Global Harmonization Task Force Final Document: Standards in the Assessment of Medical Devices

For Medical Devices

The following article is a Q&A regarding the release of the Global Harmonization Task Force Final Document: Role of Standards in the Assessment of Medical Devices (acknowledged in this article as the RSAMD final document).¹

Q: What is the Global Harmonization Task Force (GHTF)? A: The GHTF is a voluntary group that consists of trade association and medical device authorities from the USA, Canada, Europe, Japan and Australia.

Q: Who is the authoring group for the RSAMD final document? A: Study Group 1 of the GHTF is the authoring group.

Q: What is the objective of the RSAMD final document? A: It acts as a guidance (non-binding) that 1) allows for the convergence of medical device regulatory systems at a global level, 2) facilitates trade 3) allows for the flexible means to address public health in every region and 4) provides a description of the role that technical standards play when demonstrating that a device meets required principles of safety/performance.

The RSAMD final document is also one of a series of guidance documents used by the GHTF to provide a global model for the regulation of medical devices.

Q: What medical devices does the text of the RSAMD final document apply to? A: The RSAMD final document text applies to the medical devices defined in another GHTF document: "Information Document

Concerning the Definition of the Term 'Medical Device.'"² The text also applies to in vitro devices.

Q: Does the RSAMD final document update any previous guidance documents? A: Yes. The RSAMD final document supersedes a prior document and presents the following significant changes:

• Application to in vitro devices
• Includes guidance in regard to standards that--since the previous guidance--have been replaced or revised.

Q: Who are the expected audiences for the RSAMD final document? A: Regulatory Authorities (RAs), the Medical Device Industry and Conformity Assessment Bodies.

Q: Where should questions regarding the RSAMD final document be directed? A: Questions or comments regarding the RSAMD final document can be addressed by the GHTF Study Group 1 chairperson whose contact information can be located via GHTF's website.

Q: How are regulatory authorities expected to conform with guidance from the RSAMD final document? A: GHTF recognizes that some of the requirements regulated by certain bodies will not fall in line with global recommendations. However, GHTF encourages regulatory authorities to do everything possible to comply with global guidance.

Q: What are additional purposes of the RSAMD final document in addition to the objectives mentioned above? A: Additional purposes of the RSAMD final document include 1) to support an international consensus of standards and conformance with an earlier guidance: Essential Principles of Safety and Performance of Medical Devices (Essential Principles), 2) to encourage regulatory bodies to create systems or mechanisms that encourage the recognition of GHTF's Essential Principles and 3) to support the flexibility of manufacturers to demonstrate alternative solutions that meet the GHTF's Essential Principles.

Q: How are international standards defined in the RSAMD final document? A: Within the RSAMD final document international standards are defined as follows: "International standards, such as basic standards, group standards and product standards, are a tool for harmonizing regulatory processes to assure the safety, quality and performance of medical devices. Standards represent the opinion of experts from all interested parties, including industry, regulators, users and others."

Q: What principles are mentioned in the document for the achievement of harmonization? A: Recommended principles include the following:

• Industry personnel and RAs should support international standards development;
• RAs should also support the use of these standards;
• RAs should create a means or mechanism for the recognition of international standards;
• RAs should encourage the use of international standards but should also accept national, regional or other standards when used in conformance with the Essential Principles;
• When creating standards, Standards Bodies should consider the Essential Principles;
• When creating standards, Standards Bodies should provide information demonstrating which Essential Principles their new standards conform to;
• Standards should consider technologies and shouldn't discourage new innovative solutions.

Q: What are some of the additional duties of RAs according to the RSAMD final document? A: Additional responsibilities of RAs include 1) recognition of voluntary international standards, 2) the provision of notification to the public regarding those standards, 3) the assurance of a periodic review of national and international standards, 4) the assurance of a realignment of national and international standards in conjunction with the periodic review, and 5) the provision of any necessary publications in conjunction with these responsibilities.

Q: Is there any other information of interest in the RSAMD final document? A: The RSAMD final document also provides information regarding the following topics:

• "Revision of Recognised Standards" (Section 5.2)
• "Changes to the Recognition Status" (Section 5.3)
• "Use of Recognised Standards when Designing and Supplying Medical Devices both during and after the Transition Period" (Section 5.4)
• "Status of Devices Designed using the Superseded Version of the Recognised Standard and Supplied before the end of the Transition Period" (Section 5.5)
• "Alternatives to Recognised Standards" (Section 5.6)
• "Technical Documentation" (Section 5.7)