Medical Device Registration in Hong Kong

Does your company need help with medical device registration in Hong Kong? PBM’s regulatory consultants can help your product achieve cGMP compliance and access the Hong Kong medical market.

The market for medical devices in Hong Kong is more than $900 million. Hong Kong is now a part of China, but as a special administrative region, Hong Kong has its own medical device regulations separate from China. While regulations are less strict in Hong Kong, a recently-proposed regulatory framework may require licenses for certain medical device products.

Read on to learn more about the Hong Kong regulatory process, and discover how PBM regulatory consultants can get fast approval and market access for your medical device.

Hong Kong Medical Device Regulations & Approval Process

The Department of Health (DOH) is the main health authority in Hong Kong. Under the DOH, the Medical Device Control Office (MDCO) regulates medical devices.

Hong Kong currently has no mandatory registration for medical devices, but manufacturers and importers can opt for voluntary registration under the Medical Device Administrative Control System (MDACS). The government intends to make the MDACS a mandatory system in the near future.

New Hong Kong Medical Device Registration Requirements

For products voluntarily listed in the MDACS, conformity assessment during both design and manufacturing is now a requirement. Manufacturers can demonstrate their compliance with an audit conducted by a Conformity Assessment Body (CAB), a third-party assessor recognized by the Medical Device Control Office (MDCO).

Hong Kong is planning to implement new mandatory regulations on medical devices with a system that classifies products by risk level. Companies looking to stay competitive in the Hong Kong medical marketplace are hiring third-party consultants to help them maintain current good manufacturing practice (cGMP) compliance throughout this regulatory transition.

PBM Can Register Your Medical Device in Hong Kong

PBM consultants can help you voluntarily register your medical device in Hong Kong. We can help you stay ahead of regulatory trends in order to remain competitive on the Hong Kong medical markets. PBM will prepare your product for MDACS mandatory registration in order to speed your medical device past regulatory hurdles.

Whether you need consulting for medical equipment, instruments, devices or supplies, PBM regulatory affairs consultants can make sure your product gets fast market access and future MDACS approval.

Contact PBM Today

Need assistance with medical product registration in Hong Kong? Contact PBM today to receive a free consultation with a Hong Kong healthcare compliance consultant.

Need more information? Browse the PBM publications listed below for the latest info on Hong Kong medical device regulations and the MDACS.

Click here for a free 15 minute consultation from Pacific Bridge Medical

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