Dec 3, 2018
EMERGO SUMMARY OF KEY POINTS:
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.
The China Food and Drug Administration (CFDA) has begun recognizing certain certifications issued by the Hong Kong Medical Device Control Office (MDCO) for country-of-origin requirements.
Regulators in Hong Kong have published a new list of recognized standards applicable to medical devices as the region moves toward more formal oversight of its device market.