Hong Kong to Introduce Conformity Assessment Framework for Medical Devices

The Hong Kong Medical Device Control Office (MDCO) is planning to introduce a conformity assessment (CA) framework as part of its its Medical Device Administrative Control System (MDACS). The framework is intended to improve the quality management of medical devices. The CA would demonstrate that a medical device is safe and performs as intended by the manufacturer. When implemented, it would be a necessary stage of being listed in the MDACS.

In the proposal, CA would be conducted by an independent Conformity Assessment Body (CAB). This body must be recognized by the government and based in Hong Kong. The manufacturer must draw up a set of documents to demonstrate its product’s safety and accurate performance, depending on the product’s risk classification. The CAB will not only conduct the assessment but also judge the conformity of products. Alternatively, medical devices which have already undergone CA in countries such as Australia, Canada, Japan, the US, or the EU will be able to receive certification on that basis without going through a CAB.

Listing in the MDACS is not currently compulsory, and is only done on a voluntary basis. However, one of its objectives is to familiarize manufacturers with its requirements for when it becomes a system of compulsory registration in the future. Currently, there is no comprehensive set of legislation to regulate the import or sale of medical devices in Hong Kong. The MDCO launched the MDACS program in November 2004.

The MDCO plans to hold briefing sessions on its proposals on August 10, 2006. The proposed documents to be introduced are available on the MDCO website (http://www.mdco.gov.hk).