Hong Kong Regulatory Processes Overview
Medical Device regulations and import in Hong Kong operates under its own framework, controlled by the Medical Device Control Office (MDCO), a division of the Department of Health (DOH).
Products that conform to the requirements of the Medical Device Administrative Control System (MDACS) are listed in the “List of Medical Devices” and issued an MDCO listing number. Although presently voluntary, the MDCO listing number is necessary for purchasing by both most private and government payers, allowing you to gain competitive advantage and differentiate from other non-registered devices.
Classification and registration
As for many other markets, the regulatory framework in Hong Kong follows an IMDRF model and requirements vary with the device risk Class, presently:
- Class I (Low risk) medical devices and Class A-C IVDs are not registerable
- Class II-IV Medical Devices (comparable with devices IIa, IIb and III under MDD/MDR for example) and Class D IVDs are voluntarily registerable
MDCO has established a range of Technical Reference documents that highlight the requirements for compliance with the MDACS. Most requirements, including Essential Principles of Safety and Performance, are broadly similar to that of Europe and typically no additional requirements apply for Hong Kong-specific clinical testing or type testing as part of the registration process.
Labelling requirements (e.g. IFUs) are also similar, however information on the Local Representative (see below), as well as the listing number, must either be displayed on the outer packaging of every device or sales unit or on a document that is included with the device or with each delivery to the end-user or user facility.
The conformity assessment audit of a product application is conducted by a CAB (an MDCO-designated body) but will be not needed with approval in a reference market (Australia, Canada, the EU, Japan or the U.S.).
Compliance with MDACS also requires manufacturers to be ISO 13485-certified and evidence of certification is as a part of the medical device application process. MDCO registrations by listing number are valid for 5 years.
Applying under the voluntary system can also provide long-term strategic advantages. A statutory control framework for medical devices is being developed by the government to ensure that medical devices are safe, of good quality, and can perform as intended before they are allowed to be placed on the local market. The DOH has suggested that products registered under the voluntary system will be transferred directly to the regulation list without another dossier submission; those not on the voluntary list when the mandatory registration is initiated can expect long-lead times for regulatory approval.
As for most markets, companies without a local presence in Hong Kong must appoint a Local Responsible Person (LRP). The LRP must be “a legal person incorporated in Hong Kong, or a natural or legal person with a business registration in Hong Kong.” The LRP:
- applies for the device listing,
- is identified in the registration,
- is also responsible for post-market activities, including adverse incident reporting, complaint handling, and recalls.
Brandwood Biomedical has established its presence in Hong Kong, provides LRP services and can help you navigate through your pre and post-market Regulatory requirements. We work as part of your team to help you define and implement a personalized market access strategy that meets your specific business objectives. Contact us to discuss your needs and how we can help. You can drop us an Email [email protected] or call 1 888-271-5063 (US toll free) ♦ 400-842 7017 (Beijing – toll free) ♦ +61 2 9906 2984 (Sydney)