Device Registration

Hong Kong launches next phase of its medical device regulatory system

The Hong Kong Medical Device Control Office (MDCO) has announced the launch of a new conformity assessment body (CAB) recognition scheme¹. Organisations recognised under the scheme will be authorised to carry out independent assessments of products intended for listing under the MDCO's Medical Device Administrative Control System (MDACS).

The MCDO has issued three guidance documents to assist CAB applicants. These are^2-4:

• Guidance Notes GN-04: Conformity Assessment Framework and Conformity Assessment Bodies;
• Technical Reference TR-001: Principles of Conformity Assessment for Medical Devices; and
• Technical Reference TR-002: Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED).

In order to gain a MDACS listing for a device, a manufacturer needs to demonstrate device conformity compliance either through audits conducted by a CAB or by presenting current, valid marketing approvals for the device from one or more of the Global Harmonization Task Force's founding members (namely Australia, Canada, the EU, Japan and the US). Class I (low-risk) devices fall outside of the scope of listing under the MDACS.

The CAB recognition scheme, launched on 13 October 2006, represents Phase III of the implementation the MDACS. The MDCO set up the MDACS to facilitate the transition to eventual statutory control of medical device listing in Hong Kong. Currently there is no legislation to regulate medical devices and registration is voluntary, but the government intends to make these mandatory in the future through the phased implementation of MDACS⁵. Phase I commenced in November 2004 and marked the start of a voluntary listing system for Class IV medical devices. Phase II began in November 2005 and involved the extension of the MDACS to include the listing of Class II and III medical devices. In the remaining phases, the MDACS will be extended to include the listing of importers and local manufacturers.

References

1. MDCO News Release, 13 October 2006, www.mdco.gov.hk/english/news/news_20061013.html

2. GN-04 Conformity Assessment Framework and Conformity Assessment Bodies, 13 October 2006, www.mdco.gov.hk

3. TR-001 Principles of Conformity Assessment for Medical Devices, 13 October 2006, www.mdco.gov.hk

4. TR-002 Summary Technical Documentation for Demonstrating Conformity to the Essential Principled of Safety and Performance of Medical Devices (STED), 13 October 2006, www.mdco.gov.hk

5. The Regulatory Affairs Journal - Devices, 14(4), 248