NMPA issued the "2022 Medical Device Industry Standards Revisions Plan" today, April 14, 2022, for public opinions. Comments need to be submitted by April 21. The plan includes 23 mandatory and 93 recommended standards. I have listed the 23 mandatory standards below for your references. If you have any feedback to NMPA, please email us. We are consolidating the feedback.
The plan includes manufacturing methods, performance testing standards, biological evaluation, non-clinical standards, and quality systems of the 86 medical devices and IVDs.
- Surgical implants - Bone joint prosthesis forgings and castings - Part 2: ZTi6Al4V titanium alloy castings
- Surgical Implants Acrylic Bone Cement
- Single-use fluid circuits and accessories for pressure infusion devices - Part 4: Backflow prevention valves
- Ophthalmic Optics-Ophthalmic Viscoelastics
- Laser Therapy Equipment Excimer Laser Corneal Refractive Therapy Machine
- Blood purification extracorporeal circulation system Hemodialyzer, hemodiafiltration filter, extracorporeal circulation blood circuit/liquid circuit for hemofilter
- Blood Purification Extracorporeal Circulation System Hemodialyzers, Hemodiafilters, Hemofilters and Hemoconcentrators
- Surgical Instruments Linear Staplers and Components
- Surgical implants Active implantable medical devices Part 6: Particular requirements for active implantable medical devices (including implantable defibrillators) for the treatment of tachyarrhythmias
- Plasma sprayed hydroxyapatite coating Titanium based dental implants
- Dentistry Root Canal Sealing Materials
- Cardiopulmonary Bypass Systems Cardiac Surgery Hard Shell Reservoirs, Venous Reservoir Systems (with or without Filters) and Soft Venous Reservoirs Bags
- Surgical implants - Active implantable medical devices - Part 7: Requirements for cochlear and auditory brainstem implant systems
- glass syringe
- General technical requirements for thermal radiation therapy equipment
- Surgical implants - Bone and joint prosthesis forgings and castings - Part 3: Cobalt-chromium-molybdenum alloy castings
- Surgical implants - Bone joint prosthesis forgings and castings - Part 1: Ti6Al4V titanium alloy forgings
- Single-use portable infusion pump non-electrically driven
- Disposable sterile surgical membrane
- Preparation and quality management of fluids for hemodialysis and related treatments Part 2: Water for hemodialysis and related treatments
- Pressure steam sterilizer biosafety performance requirements
- Ethylene oxide sterilizer
- Dentistry Polymer-Based Restorative Materials
Industry Mandatory Standards are legally binding. Decree 739 Regulation on Supervision and Management of Medical Devices, the highest law governing medical device industry in China, mandates that "medical device shall meet the national mandatory standards; if there are no national mandatory standards, they shall comply with the industry mandatory standards".
The industry recommended standards are not legally binding but recommended by regulatory authorities. The implications for manufacturers is to make sure you plan accordingly whether you are submitting new registrations or renewing your existing registration. Especially during your every 5 year renewal process, your product may not change but since the standards are changing, you may need to perform certain local type testing to ensure your products meet the new standards.
For English version of the Decree 739 Regulation on Supervision and Management of Medical Devices, please email info@ChinaMedDevice.com.
------------------------------
Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------