China has published the final version of the updated Medical Devices Supervision and Administration Regulations on 18 March 2021 (Order No. 739, an update on Order No. 680). The new regulations will go into effect on 1 June 2021. The following are some of the updates:
Self-inspection reports are now permitted: The new Regulations allow self-inspection report of the medical device registration applicant or filing person, or an inspection report issued by a qualified medical device inspection agency.
Less requirements for innovative devices: Innovative medical devices that have not been listed overseas may not be required to submit a certification document that the competent authority of the country (region) where the device is located, allows the medical device to be sold on the market.
Conditional product approvals: For medical devices that are used to treat rare diseases, severely life-threatening diseases without effective treatment as well as major public health emergency or other emergencies that seriously threaten public health, the State Council allow a conditional approval.
Special authorization for import of a small amount of Class II and Class III devices: The State Council may authorize the importation of a small amount of Class II and Class III medical devices for urgent clinical reasons. Imported medical devices shall be used for specific medical purposes in designated medical institutions.
New IVDs development: For IVD reagents that do not have the same product on the market in China, qualified medical institutions can develop them on their own according to the clinical needs of their own units, and use them in their own units under the guidance of medical practitioners.
New set of requirements for online sales: Online sellers of Class II and III devices must declare their operations to the local FDA at the district level. The e-commerce platform that provides medical device trade services must check the sellers' identification, including their business licences and product registration status.
New penalties for the local FDA: The new regulations set fines on the local FDA if it fails to identify and address systemic medical device safety hazards in a timely manner.
Reorganization of advertising management responsibilities: The new law transfers control of medical device advertising from the local FDA to the State Administration for Market Regulation (SAMR).
Unique Device Identifier (UDI) system: UDI will be required in China and this system will be implemented in stages, and the necessary regulations and guidelines have yet to be released.
Increased of penalties for violators of the Regulations: Fines for enterprises selling or manufacturing medical devices unlawfully have been increased from RMB100,000 to RMB150,000.
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