In Brief: Hong Kong Regulators Launch Online IVD Classification Tool

EMERGO SUMMARY OF KEY POINTS:

• Hong Kong regulators unveil online classification platform for IVD devices.
• The MDCO IVD platform is designed similarly to an existing tool for medical devices.
• MDCO medical device and IVD online classification tools are for reference purposes only.

The Medical Device Control Office (MDCO), Hong Kong’s medical device and IVD market regulator, has rolled out a new online platform to help IVD manufacturers classify their products according to the jurisdiction’s requirements.

The new MDCO tool provides “rough indications for references only,” according to the website, but nonetheless provide manufacturers with a good idea of whether their products would fall under Class A, B, C or D IVD classification under Hong Kong’s Medical Device Administrative Control System (MDCAS).

The launch of MDCO’s IVD classification tool follows the regulator’s release of a similar online platform for classification of medical devices.

Additional Hong Kong medical device regulatory information:

• Hong Kong MDCO medical device registration  consulting
• Hong Kong Responsible Person in-country representation
• Medical device classification consulting
• Regulatory process chart: Hong Kong medical device registration