Class II medical device MDACS registration in Hong Kong refers to the regulatory process through which a moderate-risk medical device is formally approved for sale and distribution in the Hong Kong market. The registration process is managed under the Medical Device Administrative Control System (MDACS), which is overseen by the Medical Device Control Office (MDCO) of the Hong Kong Department of Health.

Key Points of Class II Medical Device MDACS Registration:

1. Class II Devices:

   • Class II medical devices are typically devices that pose a moderate risk to patients and users. These devices are more complex than Class I devices but less risky than Class III devices, which are considered high-risk.

   • Examples of Class II devices include diagnostic instruments, therapeutic devices, and certain surgical tools, such as infusion pumps, electrocardiograph machines, and contact lenses.

2. MDACS (Medical Device Administrative Control System):

   • MDACS is a system set up by the Hong Kong Department of Health to regulate medical devices that are imported, sold, or used in Hong Kong. It requires manufacturers or importers to ensure that devices meet local safety, efficacy, and quality standards before they can be marketed in Hong Kong.

   • MDACS registration is mandatory for Class II, III, and IV medical devices. Class I devices, which are deemed low-risk, are generally exempt from the registration process but may still need to comply with other regulatory requirements.

3. Purpose of MDACS Registration:

   • The registration ensures that the medical device meets the required safety and quality standards as outlined by the Hong Kong government.

   • The process includes reviewing the device’s technical documentation, clinical evidence, and manufacturing processes to ensure it complies with international standards (such as ISO or CE marking).

   • It is a legal requirement for manufacturers and distributors to complete this registration before selling or distributing their medical devices in Hong Kong.

4. Registration Requirements:

   • Manufacturers or their Authorized Representative (AR) in Hong Kong need to submit an application to the Medical Device Control Office (MDCO).

   • The submission includes device descriptions, performance data, clinical evidence, and compliance with relevant international standards (such as ISO 13485 for quality management systems or ISO 14971 for risk management).

   • In addition to the documentation, manufacturers may be required to provide information about adverse event reporting systems, post-market surveillance procedures, and other safety protocols.

5. Approval:

   • Once the MDCO reviews and approves the submitted application, the device will be granted registration, allowing it to be sold in Hong Kong.

   • A unique registration number will be issued, which must be included on the product labeling, indicating that the device has been properly registered and approved for market use.

6. Post-Market Responsibilities:

   • After registration, manufacturers and importers are required to ensure that their devices continue to meet safety and performance standards throughout their lifecycle.

   • This includes keeping track of post-market surveillance, reporting adverse events, and ensuring proper maintenance and recall procedures are in place.

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