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Hailing a Hong Kong CAB
23 Jul 2007
Topics: Medical devices, China
BSI has been named the first HK Conformity Assessment Body (CAB) by the Hong Kong Department of Health, under the Medical Device Administrative Control System (MDACS).
The Medical Device Control Office (MDCO) in the HK Department of Health launched the MDACS in 2004. Under the CAB Recognition Scheme, the MDCO will only recognize CABs that meet all necessary requirements, including the capacity to "carry out assessment and verification operations with the highest degree of professional integrity and requisite competence in the field of medical devices."
Through the voluntary listing system of medical devices (except Class I) and monitoring of adverse incidents, the MDACS is intended to raise public awareness of the use of safe medical devices. In addition, it will help manufacturers and importers become familiar with future mandatory requirements, as well as gathering industry feedback. As a consequence, current CE marking clients of BSI in the region will only need to submit a minimal amount of technical documentation and will enjoy faster HK approval. Companies will also be able to get CE mark and Hong Kong registration together with one assessment.
It's an important move for suppliers of medical devices in the region, as registration approval can help companies to differentiate their product and completing the registration process before it becomes mandatory could provide competitive advantage.
For more information
email medical.devices@bsi-global.com
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