The NMPA finalized the “2022 Medical Device Industry Standards Revisions Plan” on April 28, 2022, just two weeks after the draft version. The plan includes 23 mandatory and 93 recommended standards. The Standards Revisions are aimed to facilitate manufacturers with local type testing and regulatory submission and make standards more consistent with the international standards.
The plan includes manufacturing methods, performance testing standards, biological evaluation, non-clinical standards, and quality systems of the 86 medical devices and IVDs.
Industry Mandatory Standards are legally enforced. 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.
For English version of the Decree 739 Regulation on Supervision and Management of Medical Devices, please email info@ChinaMedDevice.com.
The plan lists 23 industry mandatory standards:
- 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: Particular 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
The plan also lists 93 recommended standards to be established or revised.
For English version of the 2022 Standards Revisions Plan, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.
Whether you are renewing or submitting new registration, your medical devices need to meet these new standards. Even if your renewals (every 5 years required by NMPA) have no changes, you still have to prove that your originally approved products can meet the new standards. As a result, your originally approved products will still need to go through local type testing to show that you are current with the new standards. China Med Device, LLC has test engineers at NMPA testing centers to help you assess and expedite your type testing needs and shorten your renewal or new approval time.