Medical device registration in Hong Kong has been voluntary. Over the last 10 years or so, medical devices could be registered on Hong Kong’s voluntary registration list. However, only about 20% of the medical devices sold in Hong Kong are on the voluntary registration list under the Medical Device Administrative Control System (MDACS). On June 21, the Hong Kong Department of Health (DOH) has now decided to initiate a new program for the procurement of medical devices. Going forward, all medical devices purchased by the DOH will need to be voluntarily registered on the Hong Kong MDACS. If they are not, the DOH will not buy them. Given the fact that the Hong Kong DOH is the largest buyer of devices in Hong Kong, this is a big change. This new policy will help confirm that medical devices being bought by the DOH will be safe, efficacious, and meet international requirements. Also, it is anticipated now that the HK DOH will now expedite the requirements for mandatory device registration in HK.
This change in policy was a result of a mounted examination lamp incident in the US. The supplier of this medical device did not report this problem to the Hong Kong DOH because the product was not listed on the Hong Kong voluntary listing system MDACS. This same incident occurred in HK and the product fell from the ceiling and injured the Hong Kong operator, but the medical device supplier was able to get away without any legal responsibility in Hong Kong.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.