The Medical Device Control Office (MDCO) of Hong Kong recently posted supplementary notes on registering medical devices under the Medical Device Administrative Control System (MDACS).
As discussed in Volume 6, Number 8 of the Asian Medical eNewsletter, Hong Kong implemented a voluntary registration system under the MDACS. Products listed in the MDACS require conformity assessment during both design and manufacturing. Recognized Conformity Assessment Bodies (CAB) must check and verify MDACS requirements before issuing any Conformity Assessment Certificates. Manufacturers can also meet this requirement by providing current, valid marketing approvals from a founding member of the Global Harmonization Task Force (these include Australia, Canada, the EU, Japan, and the US).
All applicants are required to prepare related documents such as the Essential Principles Conformity Checklist (MD-CCL), Risk Analysis Report/Summary, and Clinical Evaluation Documents. Or they may instead choose to submit Conformity Assessment Certificates in lieu of these three documents. However, the applicant may be required to submit these documents later if deemed necessary.
Applicants who have already prepared the Essential Requirements Checklist according to the EU Medical Device Directives and have enough evidence demonstrating MDACS compliance do not need to submit a MD-CCL.
The MDCO plans to make the MDACS a mandatory system in the future.