Gain market access in Hong Kong with conformity assessment

Medical Device Administrative Control System (MDACS) registration

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).

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), such as BSI who are recognized by the Medical Device Control Office (MDCO).

Hong Kong’s regulatory system and conformity assessment procedure

Although Hong Kong (HK) is part of China, it has a different regulatory system and imports the majority of its medical products. The Department of Health in Hong Kong set up a Medical Device Administrative Control System (MDACS) based on the International Medical Device Regulators principles. The government intends to make the MDACS a mandatory system in the near future. Under the Conformity Assessment Body (CAB) recognition scheme, the Medical Device Control Office (MDCO) will only recognize CABs such as BSI, that meet all the necessary requirements.

Understanding HK’s regulatory system is key to helping you break into this very profitable market. The purpose of the MDACS is to:

Raise public awareness of the safe use of medical devices
Enable manufacturers and other interested parties to familiarize themselves with regulations
Promote acceptance of current voluntary recommendations and future mandatory requirements for medical devices of all risk classes

What is BSI's role in market access in Hong Kong?

As the first Notified Body to officially receive approval from Hong Kong (HK) Department of Health, BSI brings its extensive CAB experience in global markets to the HK market. Our team of experts understand the challenges of global markets and the regulatory requirements unique to HK.

Under CAB, the MDCAS is only permitted to recognize CABs that operate with the highest degree of professional integrity, competence, and independence. So when you choose us as your HK CAB, you can expect the benefits of working with a world-class certification body:

Differentiate your product from non-registered products
Gain a competitive advantage by completing the registration process before it becomes mandatory
Minimize the distribution of confidential technical documentation
Get CE marking and HK Registration together with one assessment

Hong Kong medical device classification and assessment

Two certificates with one assessment

The technical documentation requirement for HK is very similar to Europe. As a registered CAB in HK and a Notified Body for CE marking, we have the ability to issue two certificates (CE marking and HK CAB approval) with only one technical assessment. This streamlined process provides great cost savings to your company, eliminating time-consuming and costly registration as you expand your business globally.

Requirements for HK Classification (based on risk)
	Class I	Class II	Class III	Class IV
Product registration	Not required	Required	Required	Required
Registration of local manufacturers	Required	Required	Required	Required
Registration of overseas manufacturer or its local representative	Not required	Required	Required	Required
Registration of importer	Required	Required	Required	Required
Registration of retailer	Not required	Not required	Not required	Not required