Commonwealth: Therapeutic Goods Amendment (Medical Devices) Act 2002 (Cth)

Therapeutic Goods Amendment (Medical Devices) Act 2002 Act No. 24 of 2002 as amended This compilation was prepared on 3 October 2007 [This Act was amended by Act No. 56 of 2002; No. 39 of 2006; No. 140 of 2007] Amendment from Act No. 56 of 2002 [Schedule 3 (item 22) repealed item 7 of Schedule 1 Schedule 3 (item 22) commenced immediately after 4 October 2002] Amendment from Act No. 39 of 2006 [Schedule 1 (item 158) repealed and substituted item 12 of Schedule 2 Schedule 1 (item 158) was repealed by Schedule 1 (item 6) of Act No. 140 of 2007 on 3 October 2007 before it commenced] Amendments from Act No. 140 of 2007 [Schedule 1 (item 7) repealed table item 3 of subsection 2(1) Schedule 1 (item 8) repealed Schedule 2 Schedule 1 (items 7 and 8) commenced on 3 October 2007] Prepared by the Office of Legislative Drafting and Publishing, Attorney‑General's Department, Canberra Contents 1 Short title 2 Commencement 3 Schedule(s) Schedule 1—Principal amendments relating to medical devices Therapeutic Goods Act 1989 An Act to amend the Therapeutic Goods Act 1989, and for related purposes [Assented to 4 April 2002] The Parliament of Australia enacts: 1 Short title This Act may be cited as the Therapeutic Goods Amendment (Medical Devices) Act 2002. 2 Commencement (1) Each provision of this Act specified in column 1 of the table commences, or is taken to have commenced, on the day or at the time specified in column 2 of the table. Commencement information Column 1 Column 2 Column 3 Provision(s) Commencement Date/Details 1. Sections 1 to 3 and anything in this Act not elsewhere covered by this table The day on which this Act receives the Royal Assent 4 April 2002 2. Schedule 1 A single day to be fixed by Proclamation, subject to subsection (3) 4 October 2002 Note: This table relates only to the provisions of this Act as originally passed by the Parliament and assented to. It will not be expanded to deal with provisions inserted in this Act after assent. (2) Column 3 of the table is for additional information that is not part of this Act. This information may be included in any published version of this Act. (3) If a provision covered by item 2 of the table does not commence within the period of 6 months beginning on the day on which this Act receives the Royal Assent, it commences on the first day after the end of that period. 3 Schedule(s) Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms. Schedule 1—Principal amendments relating to medical devices Therapeutic Goods Act 1989 1 Part 1 (heading) Repeal the heading, substitute: Chapter 1—Preliminary 2 Subsection 3(1) Insert: accessory means an article that its manufacturer specifically intended to be used together with a medical device to enable the device to be used as the manufacturer of the device intended. 3 Subsection 3(1) Insert: application audit assessment fee means a fee payable under subsection 41LA(3). 4 Subsection 3(1) Insert: assessment fee means: (a) a conformity assessment fee; or (b) an application audit assessment fee; payable under Part 4‑10. 5 Subsection 3(1) (paragraph (b) of the definition of authorised person) Omit "Part 5A", substitute "Part 6‑2". 6 Subsection 3(1) Insert: composite pack has the meaning given by subsection 7B(2). 8 Subsection 3(1) Insert: conformity assessment fee means a fee payable under subsection 41LA(1). 9 Subsection 3(1) Insert: conformity assessment procedures has the meaning given by section 41DA. 10 Subsection 3(1) Insert: conformity assessment standard means a conformity assessment standard specified in an order under section 41DC. 11 Subsection 3(1) Insert: device number, in relation to a medical device, means any combination of numbers, symbols and letters assigned to the device under section 41FL. 12 Subsection 3(1) Insert: essential principles has the meaning given by section 41CA. 13 Subsection 3(1) Insert: exempt device means a medical device that is of a kind that is exempted from Division 3 of Part 4‑11 by the regulations. 14 Subsection 3(1) (first definition of exempt goods) Omit "Part 3", substitute "Part 3‑2". 15 Subsection 3(1) (second definition of exempt goods) Omit "Part 4", substitute "Part 3‑3". 16 Subsection 3(1) (definition of exempt person) Omit "Part 4", substitute "Part 3‑3". 17 Subsection 3(1) Insert: included in the Register, in relation to a medical device to which Chapter 4 applies, means included in the Register under Chapter 4. Note: For medical devices to which Chapter 4 applies, see section 41BJ. 18 Subsection 3(1) Insert: kind, in relation to a medical device, has the meaning given by section 41BE. 19 Subsection 3(1) (definition of licence) Omit "Part 4", substitute "Part 3‑3". 20 Subsection 3(1) (definition of manufacture) After "therapeutic goods", insert "that are not medical devices". 21 Subsection 3(1) Insert: manufacturer, of a medical device, has the meaning given by section 41BG. 22 Subsection 3(1) Insert: medical device has the meaning given by section 41BD. 23 Subsection 3(1) Insert: medical device classification means a classification specified in the regulations made for the purposes of section 41DB. 24 Subsection 3(1) Insert: medical device standard, in relation to a kind of medical device, means a medical device standard, specified in an order under section 41CB, that is applicable to that kind of medical device. 25 Subsection 3(1) Insert: refurbishment has the meaning given by the regulations. 26 Subsection 3(1) (definition of Register) Omit "section 17", substitute "section 9A". 27 Subsection 3(1) Insert: system or procedure pack has the meaning given by section 41BF. 28 Subsection 3(1) (definition of therapeutic goods) After "and includes", insert "medical devices and". 29 Subsection 3(6) Omit "or an annual licensing charge", substitute ", an annual charge for inclusion in the Register or an annual licensing charge". 30 After subsection 4(1) Insert: (1A) The reference in paragraph (1)(a) to the efficacy of therapeutic goods is a reference, if the goods are medical devices, to the performance of the devices as the manufacturer intended. 31 Subsection 6A(5) Omit "Part 5", substitute "Part 6‑1". 32 At the end of subsection 6A(8) Add: ; or (c) in the part of the Register for medical devices included under Chapter 4. 33 At the end of section 7 Add: (4) If a declaration under this section: (a) is a declaration that particular goods or classes of goods are not therapeutic goods; and (b) applies wholly or partly to goods that, apart from this section, would be medical devices; the goods are not medical devices, or are not medical devices when used, advertised, or presented for supply in the way specified in the declaration. 34 Paragraph 7B(1)(b) Omit "Part 3", substitute "Part 3‑2". 35 Paragraph 7B(1)(c) After "composite pack", insert "or a system or procedure pack". 36 Paragraph 7B(2)(b) After "contain any", insert "medical devices or". 37 After section 9 Insert: Chapter 2—Australian Register of Therapeutic Goods 9A Australian Register of Therapeutic Goods (1) The Secretary is to cause to be maintained a register, to be known as the Australian Register of Therapeutic Goods, for the purpose of compiling information in relation to, and providing for evaluation of, therapeutic goods for use in humans. (2) Subject to subsection (3), the Register is to be kept in such form as the Secretary determines. (3) The Register is to contain these 3 parts: (a) a part for goods to be known as registered goods; and (b) a part for goods to be known as listed goods; and (c) a part for medical devices included in the Register under Chapter 4. (4) The regulations may prescribe: (a) the therapeutic goods, or the classes of therapeutic goods, that are required to be included in each part of the Register; and (b) the ways in which: (i) goods that are included in the part of the Register relating to registered goods may be transferred, or may be required to be transferred, to the part of the Register for listed goods; and (ii) goods that are included in the part of the Register relating to listed goods may be transferred, or may be required to be transferred, to the part of the Register for registered goods; and (c) the ways in which goods that have been assigned a registration or listing number may be assigned a different registration or listing number; and (d) the ways in which medical devices that have been assigned a device number may be assigned a different device number. (5) The Minister may, by notice published in the Gazette, require that specified therapeutic goods be included in the part of the Register for listed goods. (6) If the regulations are amended to require any of those goods to be included in the part of the Register for listed or registered goods, then the Gazette notice ceases to have effect in respect of the goods included in the regulations. 9B When registrations or listings of medical devices are taken to be cancelled (1) The registration or listing of a medical device to which subsection 15A(5) applied is taken to be cancelled: (a) on the second anniversary of the day on which Chapter 4 commences; or (b) if the medical device is of a kind included in the Register under Chapter 4 before that second anniversary—when that inclusion takes effect. (2) The registration or listing of any other medical device is taken to be cancelled: (a) on the fifth anniversary of the day on which Chapter 4 commences; or (b) if the medical device is of a kind included in the Register under Chapter 4 before that fifth anniversary—when that inclusion takes effect. (3) This section does not prevent the Secretary from taking action under section 30. 9C Inspection of entries in Register (1) The Register is not open for public inspection, but a person in relation to whom therapeutic goods are entered on the Register may make a written request to the Secretary for a copy of the entry in the Register in relation to the goods. (2) If the person makes such a request, the Secretary must send to the person a copy of so much (if any) of that entry as is contained in any computer database maintained by the Department for purposes connected with the administration of this Act (other than any part of that entry that was supplied in confidence by another person). (3) If the person makes such a request, then, instead of providing a copy of an entry to the person, the Secretary may, if the request is for the provision of an electronic copy, provide the information contained in the entry: (a) on a data processing device; or (b) by way of electronic transmission. 9D Variation of entries in Register (1) The Secretary may: (a) following a request by a person in relation to whom therapeutic goods are entered on the Register; or (b) on the Secretary's own initiative; vary the entry in the Register in relation to the goods if the entry contains information that is incomplete or incorrect. (2) If: (a) the person in relation to whom therapeutic goods are registered or listed has requested the Secretary to vary product information included in the entry in the Register that relates to the goods; and (b) the only effect of the variation would be: (i) to reduce the class of persons for whom the goods are suitable; or (ii) to add a warning, or precaution, that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy; the Secretary must vary the entry in accordance with the request. (3) If: (a) the person in relation to whom therapeutic goods are registered or listed has requested the Secretary to vary information included in the entry in the Register that relates to the goods; and (b) subsection (2) does not apply to the request; and (c) the Secretary is satisfied that the variation requested does not indicate any reduction in the quality, safety or efficacy of the goods for the purposes for which they are to be used; the Secretary may vary the entry in accordance with the request. (4) If: (a) particular therapeutic goods cease to be medical devices because of a declaration under subsection 41BD(3); and (b) those goods are included in the Register under Chapter 4 as a kind of medical device; the Secretary must move the entry relating to the goods from the part of the Register for medical devices to the part for goods to be known as registered goods or to the part for goods to be known as listed goods (whichever is applicable). (5) In this section: product information, in relation to therapeutic goods, means information relating to the safe and effective use of the goods, including information regarding the usefulness and limitations of the goods. Note: Variations to the Register also occur to give effect to limited cancellations of entries of kinds of medical devices from the Register: see subsection 41GO(2). 9E Publication of list of goods on Register The Secretary must, at least once every 12 months, publish a list of the therapeutic goods included in the Register. 38 Transitional for publication of list of goods on Register The first list published under section 9E of the Therapeutic Goods Act 1989 after the commencement of this Schedule must be published within 12 months after the last list published under section 33 of the Therapeutic Goods Act 1989. 39 Part 2 (heading) Repeal the heading, substitute: Chapter 3—Medicines and other therapeutic goods that are not medical devices Note: For 5 years following the commencement of Chapter 4 (Medical devices), this Chapter will still apply to medical devices that are registered or listed goods. Part 3‑1—Standards 40 Subparagraph 10(2)(a)(vii) Omit "Standards Association of Australia", substitute "Standards Australia International Limited". 41 After section 10 Insert: 10A Application of standards to medical devices A standard under section 10 does not apply to a medical device unless Part 3‑2 applies to the device. Note: Section 15A sets out when Part 3‑2 applies to a medical device. 42 Part 3 (heading) Repeal the heading, substitute: Part 3‑2—Registration and listing of therapeutic goods 43 Before section 16 Insert: 15A Application of this Part to medical devices The general rule (1) This Part does not apply to a medical device unless this section provides otherwise. Previously registered or listed devices (2) If a medical device is registered goods or listed goods before the commencement of this section, this Part continues to apply to the device unless the registration or listing is cancelled. Note: A registration or listing can be cancelled under section 30, or can be taken to be cancelled under section 9B. Pending applications (3) This Part continues to apply to a medical device if: (a) before the commencement of this section, an application was made under Part 3 for registration or listing of therapeutic goods that include that medical device; and (b) immediately before that commencement, the application was not yet finally determined; and (c) the application has not been, and is not, withdrawn either before or after that commencement. However, this Part ceases to apply to the device if, having been registered goods or listed goods, the registration or listing is cancelled. (4) For the purposes of paragraph (3)(b), an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of. Applications made within 2 years relating to certain medical devices (5) This Part applies to a medical device if: (a) regulations made for the purposes of this section specified either: (i) the medical device classification applying to the kind of medical device that includes that device; or (ii) medical devices of that kind; and (b) during the period of 2 years after the commencement of this section, an application was made under Part 3‑2 for registration or listing of therapeutic goods that include that medical device. However, this Part ceases to apply to the device if, having been registered goods or listed goods, the registration or listing is cancelled. Note: Medical devices that are registered or listed because of this subsection are taken to be cancelled 2 years after Chapter 4 commences, or before then if medical devices of that kind are included in the Register under Chapter 4: see subsection 9B(1). Medical devices that are exempt goods (6) This Part applies to a medical device, during the period of 2 years after the commencement of this section, if the device is exempt goods. Existing approvals under section 19 (7) This Part continues to apply to a medical device if: (a) an approval or authorisation in force under section 19 applies to the device; and (b) that approval or authorisation was in force immediately before the commencement of this section. New approvals under section 19 (8) This Part applies to a medical device if: (a) subsection (7) does not apply to the device; and (b) during the period of 2 years after the commencement of this section, an approval is granted or an authorisation is given under section 19 that applies to the device. However, this subsection does not apply after the end of that period. 44 Subsection 16(2) After "not being", insert "medical devices or". 45 Section 17 Repeal the section. 46 Saving of existing registrations and listings (1) Despite the repeal of section 17 of the Therapeutic Goods Act 1989 by item 45, any therapeutic goods that, immediately before the commencement of this Schedule, were included in the Register are taken to be included in the Register after that commencement. (2) Despite the repeal of subsection 17(5) of the Therapeutic Goods Act 1989, any notices that were in force immediately before the commencement of this Schedule, are taken to have been made under section 9A after that commencement. 47 Subsection 24B(2) Repeal the subsection, substitute: (2) Regulations made for the purposes of subsection (1) may provide that a person is not allowed to pay an evaluation fee under section 24 by instalments if any part of an instalment of: (a) that or any other evaluation fee under section 24 payable by the person; or (b) any assessment fee under section 41LA payable by the person; was unpaid immediately after the time when it became due for payment. 48 Paragraphs 25(1)(h) and (2D)(b) Omit "Part 4", substitute "Part 3‑3". 49 Subsections 25(2B), (2C) and (2G) Omit "Part 4" (wherever occurring), substitute "Part 3‑3". 50 Paragraphs 26(1)(h) and (2C)(b) Omit "Part 4", substitute "Part 3‑3". 51 Subsections 26(2A), (2B) and (2F) Omit "Part 4" (wherever occurring), substitute "Part 3‑3". 52 Subsections 26A(5) and (6) Omit "Part 4" (wherever occurring), substitute "Part 3‑3". 53 Paragraph 26A(7)(b) Omit "Part 4", substitute "Part 3‑3". 54 Sections 32 and 33 Repeal the sections. 55 Saving of existing requests for inspection or variation of the Register (1) A request for a copy of an entry in the Register under section 32 of the Therapeutic Goods Act 1989: (a) that was made before the commencement of this Schedule; and (b) that was not dealt with before that commencement; is taken, after that commencement, to be a request made under section 9C of the Therapeutic Goods Act 1989 as in force after that commencement. (2) A request for a variation of an entry in the Register under section 32 of the Therapeutic Goods Act 1989: (a) that was made before the commencement of this Schedule; and (b) that was not dealt with before that commencement; is taken, after that commencement, to be a request made under section 9D of the Therapeutic Goods Act 1989 as in force after that commencement. 56 Part 4 (heading) Repeal the heading, substitute: Part 3‑3—Manufacturing of therapeutic goods Note: The heading to section 68 is altered by omitting "Part 4" and substituting "Part 3‑3". 57 Before section 34 Insert: 33A Application of this Part to medical devices This Part does not apply to a medical device unless Part 3‑2 applies to the device. Note: Section 15A sets out when Part 3‑2 applies to a medical device. 58 Section 42 Renumber as section 41A. 59 After section 41A (as renumbered) Insert: Chapter 4—Medical devices Note: For 5 years following the commencement of this Chapter, this Chapter will not apply, and Chapter 3 (Medicines and other therapeutic goods that are not medical devices) will still apply, to medical devices that are registered or listed goods. Part 4‑1—Introduction Division 1—Overview of this Chapter 41B General The purpose of this Chapter is to ensure the safety and satisfactory performance of medical devices. It does this by: (a) setting out particular requirements for medical devices; and (b) establishing administrative processes principally aimed at ensuring those requirements are met; and (c) providing for enforcement through a series of offences. 41BA Requirements for medical devices (Parts 4‑2 and 4‑3) The requirements for medical devices are: (a) essential principles (that are about the safety and performance characteristics of medical devices); and (b) conformity assessment procedures (that are mainly about the application of quality management systems). Note: Medical device standards may be made under Division 2 of Part 4‑2, and conformity assessment standards may be made under Division 2 of Part 4‑3, but they are not requirements. 41BB Administrative processes (Parts 4‑4 to 4‑10) The administrative processes under this Chapter are: (a) issuing conformity assessment certificates for some manufacturers of medical devices; and (b) including medical devices in the Register; and (c) suspending or cancelling entries of medical devices from the Register; and (d) exempting medical devices from the requirement to be included in the Register; and (e) obtaining information about medical devices; and (f) requiring public notification of problems with medical devices, and recovery of such devices. Note: Part 4‑10 provides for assessment fees to be payable in some circumstances. 41BC Enforcement (Part 4‑11) Part 4‑11 contains offences that are aimed at ensuring that: (a) the requirements for medical devices are complied with; and (b) the administrative processes under this Chapter (particularly the inclusion of medical devices in the Register) are followed. Note: There are some offences in Parts 4‑4 to 4‑9. They generally relate to matters ancillary to administrative processes in those Parts (e.g. false or misleading statements in applications). Division 2—Interpretation 41BD What is a medical device (1) A medical device is: (a) any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following: (i) diagnosis, prevention, monitoring, treatment or alleviation of disease; (ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; (iii) investigation, replacement or modification of the anatomy or of a physiological process; (iv) control of conception; and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means; or (b) an accessory to such an instrument, apparatus, appliance, material or other article. Note: Declarations under subsection (3) exclude articles from the scope of this definition. Declarations under section 7 can also have this effect: see subsection 7(4). (2) For the purposes of paragraph (1)(a), the purpose for which an article is to be used is to be ascertained from the information supplied, by the person under whose name the article is or is to be supplied, on or in any one or more of the following: (a) the labelling on the article; (b) the instructions for using the article; (c) any advertising material relating to the article. (3) The Secretary may, by order published in the Gazette, declare that a particular instrument, apparatus, appliance, material or other article, or that a particular class of instruments, apparatus, appliances, materials or other articles, are not, for the purposes of this Act, medical devices. Note: A declaration under this section does not stop articles from being therapeutic goods. (4) A declaration under this section takes effect on the day on which the declaration is published in the Gazette or on such later day as is specified in the order. 41BE Kinds of medical devices General (1) For the purposes of this Chapter, a medical device is taken to be of the same kind as another medical device if they: (a) have the same sponsor; and (b) have the same manufacturer; and (c) have the same device nomenclature system code (see subsection (3)); and (d) have the same medical device classification; and (e) are the same in relation to such other characteristics as the regulations prescribe, either generally or in relation to medical devices of the kind in question. Unique medical devices (2) If a medical device is not of the same kind as any other medical device: (a) this Chapter applies in relation to the device as if it were a kind of medical device; and (b) references in this Chapter to delivering a reasonable number of samples of the kind of device are taken to be references to delivering the device. Device nomenclature codes (3) The regulations may specify device nomenclature codes for medical devices. 41BF System or procedure packs (1) A package and therapeutic goods in the package are a system or procedure pack if: (a) the package and the therapeutic goods are for use as a unit, either in combination as a system or in a medical or surgical procedure; and (b) the package contains at least one medical device; and (c) the package and the therapeutic goods do not constitute a composite pack. (2) To avoid doubt, a system or procedure pack is a medical device. 41BG Manufacturers of medical devices (1) The manufacturer of a medical device is the person who is responsible for the design, production, packaging and labelling of the device before it is supplied under the person's name, whether or not it is the person, or another person acting on the person's behalf, who carries out those operations. (2) If subsection (1) does not apply to a medical device, the manufacturer of the device is the person who, with a view to supplying the device under the person's name, does one or more of the following using ready‑made products: (a) assembles the device; (b) packages the device; (c) processes the device; (d) fully refurbishes the device; (e) labels the device; (f) assigns to the device its purpose by means of information supplied, by the person, on or in any one or more of the following: (i) the labelling on the device; (ii) the instructions for using the device; (iii) any advertising material relating to the device. (3) However, a person is not the manufacturer of a medical device if: (a) the person assembles or adapts the device for an individual patient; and (b) the device has already been supplied by another person; and (c) the assembly or adaptation does not change the purpose intended for the device by means of information supplied by that other person, on or in any one or more of the following: (i) the labelling on the device; (ii) the instructions for using the device; (iii) any advertising material relating to the device. 41BH Meaning of compliance with essential principles (1) A medical device complies, for the purposes of this Chapter (including Part 4‑11), with the essential principles if and only if it does not contravene any of the essential principles. (2) However, a medical device is also taken, for the purposes of this Chapter (other than Part 4‑11), to comply with the essential principles if: (a) the medical device complies with one or more medical device standards that apply to it; and (b) the medical device contravenes the essential principles only in respect of a part or parts of the essential principles to which that medical device standard, or one or more of those medical device standards, relate. (3) For the purposes of this section, a medical device standard relates to a part or parts of the essential principles only if the standard specifies that part or parts. 41BI Meaning of non‑application of conformity assessment procedures (1) A conformity assessment procedure is taken, for the purposes of this Chapter, not to have been applied to a medical device if: (a) there has been a contravention of the conformity assessment procedures; and (b) the contravention relates, wholly or partly, to that device or its manufacture. (2) However, for the purposes of this Chapter (other than Part 4‑11), subsection (1) does not apply if: (a) the quality management system applied in the manufacture of the medical device complies with one or more conformity assessment standards that apply to it; and (b) the contravention is only in respect of a part or parts of the conformity assessment procedures to which that conformity assessment standard, or one or more of those conformity assessment standards, relate. (3) For the purposes of this section, a conformity assessment standard relates to a part or parts of the conformity assessment procedures only if the standard specifies that part or parts. Division 3—Application provisions 41BJ Application of this Chapter to medical devices covered by Part 3‑2 (1) This Chapter does not apply to a medical device if section 15A applies to the device, except for purposes connected with: (a) applications for including the medical device in the Register under this Chapter; or (b) including the medical device in the Register under this Chapter. Note: Section 15A sets out the circumstances in which Part 3‑2 applies or continues to apply to medical devices. (2) However, if an exemption under section 34 applied to a medical device, or the manufacturer of the device, immediately before the commencement of this Chapter: (a) Parts 4‑3 and 4‑4, and Division 2 of Part 4‑11, apply in relation to the device after the end of the period of 2 years after that commencement; and (b) Parts 4‑8, 4‑9 and 4‑10, and Divisions 3 and 4 of Part 4‑11, apply in relation to the device, to the extent that they relate to any of the provisions referred to in paragraph (a), after the end of that period. 41BK Application of the Criminal Code Chapter 2 of the Criminal Code applies to all offences against this Chapter. Note: Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility. Part 4‑2—Essential principles and medical device standards 41C What this Part is about The essential principles set out the requirements relating to the safety and performance characteristics of medical devices. Compliance with applicable medical device standards is not required, but it is one way to establish compliance with essential principles. Note: Dealing in medical devices that do not comply with the essential principles may be an offence: see Division 1 of Part 4‑11. Division 1—Essential principles 41CA Essential principles (1) The regulations may set out requirements for medical devices. (2) These requirements are to be known as the essential principles. Division 2—Medical device standards 41CB Medical device standards (1) The Minister may, by order published in the Gazette, determine that: (a) matters specified in the order constitute a medical device standard for kinds of medical devices identified in the order; and (b) medical devices of those kinds that comply with the standard are to be treated as complying with those parts of the essential principles specified in the standard. (2) A medical device standard takes effect on the day on which the order establishing the medical device standard is published in the Gazette or on such later day as is specified in the order. (3) A medical device standard is a disallowable instrument for the purposes of section 46A of the Acts Interpretation Act 1901. 41CC Content of medical device standards (1) Without limiting the scope of section 41CB, an order establishing a medical device standard for kinds of medical devices may be specified by reference to: (a) the safety or performance characteristics of the devices; or (b) a monograph in the British Pharmacopoeia, the European Pharmacopoeia or the United States Pharmacopoeia; or (c) a monograph in a publication approved by the Minister for the purposes of this subsection; or (d) such a monograph as modified in a manner specified in the order; or (e) a standard published by a standards organisation; or (f) such other matters as the Minister thinks fit. (2) For the purposes of paragraph (1)(e), these are standards organisations: (a) Standards Australia International Limited; (b) the International Organisation for Standardization; (c) the International Electrotechnical Commission; (d) the European Committee for Standardization; (e) the European Committee for Electrotechnical Standardization; (f) any other organisation declared by the Minister by notice published in the Gazette. 41CD Inconsistencies between medical device standards (1) A medical device standard that: (a) applies to a kind of medical device; and (b) is inconsistent with another medical device standard that applies only to some of the devices of that kind; is, to the extent of the inconsistency, of no effect in relation to the devices referred to in paragraph (b). (2) A medical device standard that applies to a kind of medical device that consists of a combination of component parts takes precedence over any medical device standard that applies to the component parts. Part 4‑3—Conformity assessment procedures 41D What this Part is about The conformity assessment procedures set out the requirements relating to the application of quality management systems for medical devices, and other requirements imposed on manufacturers. Compliance with applicable conformity assessment standards is not required, but it is one way to establish that one or more parts of the conformity assessment procedures have been applied to medical devices. Note 1: Dealing in medical devices that have not had the conformity assessment procedures applied may be an offence: see Division 2 of Part 4‑11. Note 2: See section 41BI on applying the conformity assessment procedures. Division 1—Conformity assessment procedures 41DA Conformity assessment procedures (1) The regulations may set out requirements relating to the obligations of manufacturers of medical devices. (2) These requirements are to be known as the conformity assessment procedures. (3) The conformity assessment procedures, or any part of the conformity assessment procedures, may: (a) be limited in their application to one or more medical device classifications; or (b) apply differently to different medical device classifications, different kinds of medical devices or different manufacturers. (4) Without limiting subsection (1), the regulations may relate to all or any of the following: (a) application of quality management systems for the manufacture of medical devices; (b) certification of compliance with the essential principles, or the quality management systems for the manufacture of medical devices; (c) notification of, and assessment of, changes to a manufacturer's product range, product design or quality management systems; (d) declarations to be made by manufacturers of medical devices that conformity assessment procedures have been applied to the devices; (e) marks to be affixed to medical devices indicating the application of the conformity assessment procedures to the devices; (f) monitoring and inspecting the design of medical devices or the manufacturing processes for medical devices; (g) monitoring the performance of medical devices; (h) corrective action required in relation to the design, manufacture, packaging, labelling and supply of medical devices; (i) keeping records of the manufacture of medical devices, the design of medical devices or the manufacturing processes for medical devices. 41DB Medical device classifications The regulations may specify: (a) classifications, to be known as medical device classifications, applying to medical devices or kinds of medical devices; and (b) matters in relation to the classification of medical devices or kinds of medical devices. Division 2—Conformity assessment standards 41DC Conformity assessment standards (1) The Minister may, by order published in the Gazette, determine that: (a) matters specified in the order constitute a conformity assessment standard for quality management systems identified in the order; and (b) a quality management system that complies with the standard is to be treated as having had applied to it those parts of the conformity assessment procedures specified in the standard. (2) A conformity assessment standard may be limited to particular kinds of medical devices. (3) A conformity assessment standard takes effect on the day on which the order establishing the conformity assessment standard is published in the Gazette or on such later day as is specified in the order. (4) A conformity assessment standard is a disallowable instrument for the purposes of section 46A of the Acts Interpretation Act 1901. 41DD Content of conformity assessment standards (1) Without limiting the scope of section 41DC, an order establishing a conformity assessment standard for a kind of medical device may be specified by reference to: (a) procedures to be carried out under the quality management systems for the design, manufacture and final inspection of the devices; or (b) a standard published by a standards organisation; or (c) such other matters as the Minister thinks fit. (2) For the purposes of paragraph (1)(b), these are standards organisations: (a) Standards Australia International Limited; (b) the International Organisation for Standardization; (c) the European Committee for Standardization; (d) any other organisation declared by the Minister by notice published in the Gazette. 41DE Inconsistencies between conformity assessment standards A conformity assessment standard that: (a) identifies quality management systems to which it applies; and (b) is inconsistent with another conformity assessment standard that applies only to particular kinds of medical devices; is, to the extent of the inconsistency, of no effect in relation to the devices referred to in paragraph (b). Part 4‑4—Conformity assessment certificates 41E What this Part is about The Secretary can issue a conformity assessment certificate (which may be limited to some medical devices) in respect of a manufacturer of medical devices, signifying one or more of these: (a) that relevant quality management systems have been applied to the device; (b) the essential principles for the device have been complied with; (c) other certification requirements of the conformity assessment procedures have been met. Note: A conformity assessment certificate may be required before a valid application can be made for including a kind of medical device in the Register under this Chapter: see subsection 41FC(2). Division 1—Issuing conformity assessment certificates 41EA When conformity assessment certificates are required The regulations may prescribe: (a) kinds of manufacturers in respect of whom a conformity assessment certificate must be issued before valid applications can be made for kinds of medical devices, manufactured by those manufacturers, to be included in the Register; or (b) kinds of medical devices in respect of which a conformity assessment certificate must be issued before valid applications can be made for those kinds of medical devices to be included in the Register. Note: The regulations may prescribe different levels of fees for different kinds of manufacturers and medical devices: see subsection 41LA(2). 41EB Applications (1) An application for a conformity assessment certificate must: (a) be made in accordance with a form approved, in writing, by the Secretary or in such other manner as is approved, in writing, by the Secretary; and (b) be delivered to an office of the Department specified by the Secretary. Note: A conformity assessment fee is payable under section 41LA for consideration of the application. (2) An application is not effective if: (a) the prescribed application fee has not been paid; or (b) the application contains information that is false or misleading in a material particular. Note: A person might also be guilty of an offence if the person makes a statement in an application that is false or misleading in a material particular: see section 41EI. (3) An approval of a form may require or permit an application or information to be given in accordance with specified software requirements: (a) on a specified kind of data processing device; or (b) by way of a specified kind of electronic transmission. (4) The Secretary may, by written notice given to an applicant for a conformity assessment certificate, require the applicant to allow an authorised person, at any reasonable time specified in the notice, to inspect: (a) the premises (including premises outside Australia) and equipment, processes and facilities that are being or will be used to manufacture medical devices of the kind in question; and (b) any other kinds of medical devices on those premises. 41EC Considering applications (1) If the application is made in accordance with section 41EB, the Secretary must decide whether to issue the conformity assessment certificate. (2) In deciding whether to issue the certificate, the Secretary must consider some or all aspects of whether the conformity assessment procedures relating to one or more of the following have been applied to the medical device: (a) the application of quality management systems for the manufacture of medical devices; (b) the certification of compliance with the essential principles; (c) any other requirement of the conformity assessment procedures specified in regulations made for the purposes of this subsection. 41ED Time for making decisions on applications (1) If the application relates to the issuing of a conformity assessment certificate in relation to which a period has been prescribed under paragraph 63(2)(dc), a decision on the application must be made within that period, unless the application lapses under section 41EG. (2) A failure to make a decision on the application within that period does not render the Commonwealth, the Secretary or a delegate of the Secretary liable to a person in respect of loss, damage or injury of any kind caused by, or arising out of, the failure. 41EE Procedure following making a decision whether to issue certificate (1) After making a decision whether to issue a conformity assessment certificate, the Secretary must: (a) notify the applicant in writing of his or her decision within 20 working days; and (b) if the decision is not to issue the certificate—state in the notice the reasons for the decision; and (c) if the decision is to issue the certificate and all assessment fees that are due and payable for the application have been paid: (i) issue the certificate to the manufacturer in relation to whom the application was made; and (ii) give the applicant a copy of the certificate (if the applicant is not the manufacturer). (2) A conformity assessment certificate must specify whether it covers: (a) all medical devices manufactured by the manufacturer; or (b) only specified medical devices manufactured by the manufacturer. 41EF Duration of certificate (1) The conformity assessment certificate commences on the day specified for the purpose in the certificate. (2) A conformity assessment certificate has effect at all times: (a) unless the certificate is suspended under Division 3; or (b) until the end of the period (if any) specified in the certificate; or (c) until the certificate is revoked under Division 4. 41EG Lapsing of applications An application for a conformity assessment certificate lapses if: (a) the applicant does not deliver to the office to which the application was made such information (in a form approved in writing by the Secretary) as will allow the certificate to be issued; or (b) the applicant does not comply with a requirement by the Secretary to deliver to the office to which the application was made a reasonable number of samples of the kind of medical device to which the application relates; or (c) the applicant fails to comply with a notice under section 41JA to give to the Secretary information relating to a kind of medical device to which the application relates within a further 10 working days from the day specified in the notice; or (d) information given to the Secretary by, or on behalf of, the applicant in connection with the application, including information given for the purpose of a notice under section 41JA, is false or misleading in a material particular; or (e) the applicant fails to allow an authorised person to carry out any inspection as required under subsection 41EB(4); or (f) the applicant fails to pay an assessment fee for the application within the period, specified in the regulations, after being notified of the decision to issue a conformity assessment certificate under section 41EE. 41EH Treating applications as having been refused (1) The applicant for an application for a conformity assessment certificate may give the Secretary written notice that the applicant wishes to treat the application as having been refused if: (a) a period is prescribed under paragraph 63(2)(dc) for making a decision on the application; and (b) at the end of the period, the applicant has not been notified of a decision whether to issue the certificate. (2) The notice may be given at any time before the applicant is notified of the decision. (3) If a notice has been given, this Act (except for subsection 60(5)) has effect as if: (a) the Secretary had decided not to issue the certificate; and (b) the Minister had made a decision under subsection 60(3) confirming the decision of the Secretary; and (c) the Minister's decision had been made on the day on which notice was given to the Secretary. 41EI False statements A person is guilty of an offence if: (a) the person makes a statement (whether orally, in a document or in any other way); and (b) the person knows that the statement is false or misleading in a material particular; and (c) the statement is in or in connection with an application for a conformity assessment certificate. Maximum penalty: 60 penalty units. Division 2—Conditions Note: Breaching conditions of the conformity assessment certificate may lead to suspension or revocation of the certificate (see Divisions 3 and 4), and may be an offence (see subsection 41MN(2)). 41EJ Automatic conditions on conformity assessment certificates Entry and inspection powers (1) A conformity assessment certificate is subject to the conditions that the manufacturer in respect of whom the certificate is issued will: (a) allow an authorised person: (i) to enter, at any reasonable time, premises (including premises outside Australia) at which the person or any other person deals with medical devices of a kind covered by the certificate; and (ii) while on those premises, to inspect those premises and medical devices of that kind at those premises and to take samples of devices of that kind; and (iii) to carry out tests, or require tests to be carried out, on the premises on medical devices of a kind covered by the certificate; and (b) if requested to do so by an authorised person: (i) produce to the person such documents relating to devices of that kind, or to the manufacturer's quality management system, as the person requires; and (ii) allow the person to copy the documents. Review (2) A conformity assessment certificate is subject to the condition that the manufacturer in respect of whom the certificate is issued will cooperate in any review by the Secretary of the certificate to determine whether the conformity assessment procedures relating to the following matters have been applied to the kinds of medical devices covered by the certificate: (a) the application of quality management systems for the manufacture of medical devices; (b) the certification of compliance with the essential principles; (c) any other requirement of the conformity assessment procedures specified in the regulations made for the purposes of subsection 41EC(2). Notification of substantial changes (3) A conformity assessment certificate is subject to the condition that the person in respect of whom the certificate is issued will notify the Secretary, in writing, of any plan for substantial changes to: (a) quality management systems; or (b) the product range covered by those systems; or (c) the product design of kinds of medical devices; in respect of which the certificate is issued. Fees (4) A conformity assessment certificate is subject to the condition that the applicant for the certificate will pay a fee, prescribed in the regulations, for a review under subsection (2), when the fee becomes due and payable. (5) The regulations may prescribe different levels of fees for different kinds of manufacturers and medical devices. Conditions do not limit other conditions (6) A condition imposed under this section is in addition to any conditions imposed under this Division. 41EK Conditions imposed when conformity assessment certificates are issued If the Secretary issues a conformity assessment certificate in respect of a manufacturer, the Secretary may, in writing, impose conditions on the certificate in respect of: (a) one or more kinds of medical devices covered by the certificate; or (b) the manufacturer's quality management system. 41EL Conditions imposed after issuing a conformity assessment certificate (1) The Secretary may, by written notice given to a manufacturer in respect of whom a conformity assessment certificate has been issued: (a) impose new conditions on the certificate in respect of: (i) one or more kinds of medical devices covered by the certificate; or (ii) the manufacturer's quality management system; or (b) vary or remove existing conditions. The power may be exercised at the request of the applicant for the certificate or on the Secretary's own initiative. (2) The imposition or variation of a condition under this section takes effect: (a) if the notice states that the action is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or (b) in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person. Division 3—Suspension of conformity assessment certificates Note: Suspension of a conformity assessment certificate leads to suspension from the Register of the kinds of medical devices to which the certificate applied (see subsection 41GF(1)). Applications to include such devices in the Register are not effective (see paragraph 41FC(2)(c)). 41EM Suspension of conformity assessment certificates (1) The Secretary may, by written notice given to the person in relation to whom a conformity assessment certificate is issued, suspend the certificate if the Secretary is satisfied that it is likely that there are grounds for revoking the certificate under section 41ET. (2) The suspension may be limited to some medical devices of that kind, as specified in the notice. (3) The notice must specify the period of the suspension. The period must not exceed 6 months. Note: The period of the suspension may be extended under section 41EO. 41EN Notice of proposed suspension (1) However, before suspending a conformity assessment certificate, the Secretary must: (a) inform the person in writing that the Secretary proposes the suspension and set out the reasons for it; and (b) give the person a reasonable opportunity to make submissions to the Secretary in relation to the proposed suspension. (2) The Secretary is not to make a decision relating to the proposed suspension until the Secretary has had regard to any submissions the person makes under paragraph (1)(b). (3) This section does not apply if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury. 41EO Duration of suspension (1) The suspension takes effect: (a) if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or (b) in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person. (2) The suspension has effect until: (a) the Secretary revokes it under section 41EP; or (b) the expiry of: (i) the period specified in the notice under section 41EM; or (ii) if the period is extended under subsection (3) of this section, the period as so extended. Note: Unless a suspension of a conformity assessment certificate has been revoked, the certificate is automatically revoked: see section 41ER. (3) If a person in relation to whom a kind of medical device is included in the Register shows that he or she has taken steps to address the grounds for revoking the certificate under section 41ET, the Secretary may, by written notice given to the person, extend the period specified in the notice under section 41EM by a further specified period not exceeding 6 months. 41EP Revocation of suspension (1) The Secretary must revoke the suspension if the Secretary is satisfied that: (a) the ground on which the conformity assessment certificate was suspended no longer applies; and (b) there are no other grounds for suspending the certificate. (2) The Secretary's power to revoke the suspension may be exercised: (a) if: (i) the manufacturer in relation to whom the conformity assessment certificate was issued; or (ii) the person who applied for the certificate (if the applicant was not the manufacturer); applies in writing to the Secretary; or (b) on the Secretary's own initiative. (3) After revoking the suspension, the Secretary must, within 20 working days after the revocation, give written notice of the revocation to the person in relation to whom the conformity assessment certificate was issued. (4) If the Secretary decides, after an application is made under paragraph (2)(a), not to revoke the suspension, the Secretary must: (a) notify the applicant in writing of his or her decision within 20 working days after the decision is made; and (b) state in the notice the reasons for the decision. 41EQ Powers of revocation of conformity assessment certificates unaffected (1) This Division does not affect the Secretary's powers to revoke a conformity assessment certificate under Division 4. (2) To the extent that a suspension under this Division relates to a conformity assessment certificate to which such a revocation relates, the suspension ceases to have effect. Division 4—Revocation of conformity assessment certificates Note: Revocation of a conformity assessment certificate leads to cancellation of the entry from the Register of the kinds of medical devices to which the certificate applied (see paragraph 41GK(b)). Applications to include such devices in the Register are not effective (see paragraph 41FC(2)(c)). 41ER Automatic revocation of conformity assessment certificates The Secretary must, by written notice given to the person in relation to whom a conformity assessment certificate is issued, revoke the certificate if: (a) the certificate has been suspended under section 41EM; and (b) the period applying to the suspension under subsection 41EM(3) or 41EO(3) (as the case requires) expires before the suspension is revoked under section 41EP. 41ES Immediate revocation of conformity assessment certificates The Secretary may, by written notice given to the manufacturer in relation to whom a conformity assessment certificate is issued, revoke the certificate if the manufacturer requests in writing the revocation of the certificate. 41ET Revocation of conformity assessment certificates after notice of proposed revocation (1) The Secretary may, by written notice given to the person in relation to whom a conformity assessment certificate is issued, revoke the certificate if: (a) the conformity assessment procedures have not been applied to medical devices of a kind to which the certificate applies; or (b) the manufacturer in relation to whom the certificate is issued refuses or fails to comply with a condition to which the certificate is subject; or (c) the Secretary gives to the person a notice under section 41JA that requires the person to give to the Secretary information or documents relating to: (i) a kind of medical device; or (ii) a quality management system to which the certificate applies; and the person fails to comply with that notice within a further 10 working days from the day specified in that notice; or (d) the manufacturer in respect of whom the certificate is issued no longer manufactures any of the kinds of medical devices to which the certificate applies. (2) However, before revoking the certificate, the Secretary must: (a) inform the person in writing that the Secretary proposes the revocation and set out the reasons for it; and (b) give the person a reasonable opportunity to make submissions to the Secretary in relation to the proposed revocation. (3) The Secretary is not to make a decision relating to the proposed revocation until the Secretary has had regard to any submissions the person makes under paragraph (2)(b). 41EU Limiting revocation of conformity assessment certificates to some medical devices of a particular kind (1) If the Secretary is satisfied that the ground for revoking a conformity assessment certificate applies only to: (a) some of the kinds of medical devices to which the certificate applies; or (b) some medical devices of the kinds to which the certificate applies; the Secretary must limit the revocation to the medical devices to which that ground or any other ground for revocation applies. (2) If the revocation of the certificate is so limited, the Secretary must vary the certificate so that it no longer applies to the medical devices referred to in subsection (1). 41EV Publication of revocation etc. of conformity assessment certificates The Secretary must cause to be published in the Gazette, as soon as practicable after revoking a conformity assessment certificate, or varying a conformity assessment certificate under subsection 41EU(2), a notice setting out particulars of the revocation or variation. 41EW Date of effect of revocation etc. of conformity assessment certificates If the Secretary revokes a conformity assessment certificate, or varies a conformity assessment certificate under subsection 41EU(2), the revocation or variation has effect: (a) if the revocation is under section 41ER or 41ES, or the variation relates to a ground of revocation in section 41ER or 41ES—on the day on which the notice of revocation or variation is given to the person in relation to whom the certificate was issued; or (b) in any other case—on such later day as is specified in the notice. Part 4‑5—Including medical devices in the Register 41F What this Part is about Kinds of medical devices can be included in the Register if they comply with the essential principles, and conformity assessment procedures have been applied to the kinds of devices (and certain other requirements are complied with). Inclusions in the Register are subject to certain automatic conditions and the Secretary may impose further conditions. Division 1—Including medical devices in the Register 41FA What this Division is about Kinds of medical devices are usually included in the Register automatically once a proper application is made, together with the required certification. However, applications may be selected for audit, which involves checking some or all aspects of the application and certification. Note 1: In some cases, an application relating to a kind of medical device will not be effective unless that kind of device is covered by a conformity assessment certificate under Part 4‑4: see paragraph 41FC(2)(c). Note 2: Dealing in medical devices of a kind not included in the Register may be an offence: see Division 3 of Part 4‑11. 41FB How this Division works This diagram shows how this Division applies to an application for a kind of medical device to be included in the Register. Subdivision A—Applications 41FC Applications (1) An application for a kind of medical device to be included in the Register must: (a) be made in accordance with a form approved, in writing, by the Secretary or in such other manner as is approved, in writing, by the Secretary; and (b) be delivered to an office of the Department specified by the Secretary. (2) An application is not effective if: (a) the application is not made in accordance with subsection (1); or (b) the prescribed application fee has not been paid; or (c) regulations made for the purposes of section 41EA require the manufacturer of the kind of device to have a conformity assessment certificate relating to the kind of medical device before an application under this section can be made, and no such certificate is in force; or (d) the application contains information that is false or misleading in a material particular. Note: A person might also be guilty of an offence if the person makes a statement in an application that is false or misleading in a material particular: see section 41FE. (3) An approval of a form may require or permit an application or information to be given in accordance with specified software requirements: (a) on a specified kind of data processing device; or (b) by way of a specified kind of electronic transmission. 41FD Matters to be certified The applicant must certify that: (a) devices of the kind in question are medical devices; and (b) devices of that kind are intended for a specified purpose, as ascertained under subsection 41BD(2); and (c) the kind of device is correctly classified according to the medical device classifications; and (d) devices of that kind comply with the essential principles; and (e) the applicant: (i) has available sufficient information to substantiate that compliance with the essential principles; or (ii) has procedures in place, including a written agreement with the manufacturer of the kind of devices setting out the matters required by the regulations, to ensure that such information can be obtained from the manufacturer within the period specified in the regulations; and (f) an appropriate conformity assessment procedure has been applied to devices of that kind; and (g) the applicant: (i) has available sufficient information to substantiate the application of those conformity assessment procedures; or (ii) has procedures in place, including a written agreement with the manufacturer of the kind of devices setting out the matters required by the regulations, to ensure that such information can be obtained from the manufacturer within the period specified in the regulations; and (h) devices of that kind comply with every requirement (if any) relating to advertising applicable under the regulatio