Therapeutic Goods Amendment (Overseas Regulators) Determination 2019
I, Miranda Lauman, as delegate of the Secretary of the Department of Health, make the following determination.
Dated 8 April 2019
Miranda Lauman
Assistant Secretary
Medical Devices Branch
Health Products Regulation Group
Department of Health
Contents
1 Name
2 Commencement
3 Authority
4 Amendments
Schedule 1—Amendments
Therapeutic Goods (Overseas Regulators) Determination 2018
1 Name
This instrument is the Therapeutic Goods Amendment (Overseas Regulators) Determination 2019.
2 Commencement
(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
Commencement information |
Column 1 | Column 2 | Column 3 |
Provisions | Commencement | Date/Details |
1. The whole of this instrument | The day after this instrument is registered. | |
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
3 Authority
This instrument is made under subsection 41BIB(2) of the Therapeutic Goods Act 1989.
4 Amendments
Each instrument that is specified in a Schedule to this instrument is amended as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
Schedule 1—Amendments
Therapeutic Goods (Overseas Regulators) Determination 2018
1 Section 3
Omit “Act”, substitute “Therapeutic Goods Act 1989”.
2 Section 4
Insert:
IAF accredited conformity assessment body means a body that is accredited to undertake certification for compliance with ISO 13485 by an accreditation body member that is a signatory to the Multilateral Recognition Arrangement of the International Accreditation Forum, Inc., otherwise known as the IAF MLA.
ISO 13485 means International Standard ISO 13485:2016 Medical devicesQuality management systemsRequirements for regulatory purposes, issued by the International Organization for Standardization in March 2016, as in force or existing immediately before the commencement of this instrument.
Note: ISO 13485 is published at: https://www.iso.org.
3 Section 5
Insert:
(aa) an IAF accredited conformity assessment body;
4 Paragraph 5(e)
Omit “and”.
Overview
The Therapeutic Goods Amendment (Overseas Regulators) Determination 2019 was made by Miranda Lauman, acting as the delegate of the Secretary of the Department of Health, under subsection 41BIB(2) of the Therapeutic Goods Act 1989. This legislation was introduced to address specific gaps in the existing regulatory framework concerning the recognition of overseas regulators for therapeutic goods. The primary objective of this determination is to amend the Therapeutic Goods (Overseas Regulators) Determination 2018 to ensure that it aligns with current standards and practices, particularly in the context of medical devices. The commencement of this determination occurred the day after it was registered, and it aims to incorporate changes that reflect the evolving landscape of medical device regulation and the international standards set by bodies like the International Accreditation Forum.
Scope and Application
The Therapeutic Goods Amendment (Overseas Regulators) Determination 2019 applies to the Therapeutic Goods Act 1989, specifically modifying the Therapeutic Goods (Overseas Regulators) Determination 2018. This determination outlines the requirements for conformity assessment bodies that are accredited by the International Accreditation Forum (IAF), thereby ensuring compliance with ISO 13485:2016, which pertains to quality management systems for medical devices. The legislation impacts entities involved in the certification of medical devices, ensuring that these entities meet international standards for quality and safety. The scope of this Act is national, applying across Australia, and it is applicable to any person or entity engaged in the certification process of medical devices as regulated by the Therapeutic Goods Act 1989. There are no specific exclusions mentioned in the text, but the application is limited to conformity assessment bodies accredited by the IAF. This Act extends its reach through subordinate instruments, which may further define and refine the application of these standards within Australia.
Key Provisions
The Therapeutic Goods Amendment (Overseas Regulators) Determination 2019 amends the Therapeutic Goods (Overseas Regulators) Determination 2018. The primary changes include updating references to the Therapeutic Goods Act 1989, defining new terms such as "IAF accredited conformity assessment body" and "ISO 13485," and expanding the list of acceptable conformity assessment bodies in section 5 to include IAF accredited bodies. These amendments aim to align the legislation with current international standards and accreditation practices.
The amended legislation imposes obligations on entities that wish to rely on the assessments of overseas regulators for therapeutic goods. These entities must ensure that any conformity assessment conducted by an accredited body adheres to ISO 13485 standards. They must also ensure that the conformity assessment body is either listed in the Therapeutic Goods Order No. 87 or accredited by an IAF member that is a signatory to the IAF MLA. The determination seeks to maintain high standards of quality and safety in the importation of therapeutic goods.
Failure to comply with the provisions of this determination can result in significant consequences. The Therapeutic Goods Act 1989 provides for various offences and penalties for non-compliance. For example, knowingly supplying therapeutic goods that do not comply with the Act can result in substantial fines. The maximum penalty for individuals can be up to $330,000 or imprisonment for up to five years, or both. For corporations, the penalty can be much higher, reaching up to $1.65 million. These penalties reflect the seriousness with which the Australian government treats the regulation of therapeutic goods to protect public health.