NMPA issued the draft version of “2023 Medical Device Industry Standards Revisions Plan” on May 12, 2023, with the deadline for feedbacks on May 19. The plan proposes 15 mandatory and 102 recommended standards to be revised or established. The Standards Revisions are aimed to facilitate manufacturers with local type testing and regulatory submission and make standards more consistent with the international standards.
Scope
The plan includes manufacturing methods, performance testing standards, biological evaluation, non-clinical standards, and quality systems of the 86 medical devices and IVDs.
Legally Binding
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.
Mandatory Standards
The plan lists 15 industry mandatory standards for the items as follow:
- Medical Electrical Equipment Part 2-87: Specific requirements for basic safety and basic performance of high-frequency ventilators
- Electric gastric lavage machine
- Blood pressure sensor
- Bone joint implant devices Metal bone screws
- Bone joint implant device Metal bone plate
- Traditional Chinese medicine equipment Electroacupuncture treatment instrument
- Single-use leukocyte de-leukocyte filter
- Laser Treatment Equipment Q-switched eye laser treatment machine
- Cardiopulmonary diversion system One-time use of arteriovenous cannula
- Hemoperfusion equipment
- Single-use hollow fiber plasma separator and plasma component separator
- Dentistry Water-based Hydrostatine Part 2: Resin-modified Watergate Enterpistine
- Dentistry Artificial teeth for restoration
- Dentistry Polymer-based crowns and veneer materials
- Dentistry Matching tests of metal-ceramic and ceramic-ceramic systems
The draft plan also lists 102 recommended standards to be established or revised.
For English version of the 2023 Standards Revisions Draft Plan, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.
Huge Impact
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.
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- Source: https://chinameddevice.com/standards-revisions-2023/
