Two year ago, China’s National Medical Products Agency (NMPA) announced on February of 2018 that the revisions of more than 300 industry standards for Medical Devices, IVDs and their respective quality systems would be expected by the end of 2020.

Recently in March of 2020, the NMPA issued the 2020 Medical Device Industry Standards Revisions Plan . The Standards will affect 86 different medical devices and IVD standards. The NMPA plans to formulate 52 medical device industry standards and amend 34 items; of which, 9 items are mandatory standards and 77 items are recommended industry standards.  The plan also includes standards for manufacturing methods, performance testing standards, biological evaluation, non-clinical standards and quality systems of the specified Medical Device and IVDS. Chinese Health Officials aim to use these revised standards to facilitate local type testing for manufacturers as well as provide more harmonization with international standards.

Are the Standards Obligatory?

Yes, Industry Mandatory Standards are legally enforced under Decree 680: Regulation on Supervision and Management of Medical Devices. This Decree 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 are recommended by regulatory authorities.

What this Means for Medical Device Manufacturers:

A Manufacturer who is in the process of renewing or submitting a new registration for a medical devices must meet these new standards. The standards include renewals and no changes or updates to the product or label. The Manufacture must prove to the NMPA that the originally approved products meets the new standards. Consequently, for manufacturers this means that the originally approved products will need to go through another round of local type testing to show that you are current with the new standards.

Mandatory Standards:

The Plan Lists 9 Mandatory Standards:

  1. Specific Requirements for Passive surgical implants and breast implants
  2. Liver radiofrequency ablation treatment equipment
  3. Medical electrical equipment Part 2-80: Particular requirements for basic safety and basic performance of respiratory support equipment for respiratory insufficiency
  4. Medical electrical equipment Part 2-79: Particular requirements for basic safety and basic performance of respiratory support equipment for respiratory dysfunction
  5. Medical electrical equipment Part 2-78: Special requirements for rehabilitation, evaluation, compensation or mitigation of basic safety and basic performance of medical robots
  6. Medical electrical equipment. Part 2-56: Particular requirements for basic safety and basic performance of clinical thermometers for body temperature measurement
  7. Medical electrical equipment Part 2-77: Particular requirements for basic safety and basic performance of robot-assisted surgical equipment
  8. Surgical implants. Active implantable medical devices. Part 5: Circulation support devices
  9. Ophthalmic optics, intraocular lens part 8: basic requirements

About Global Regulatory Partners:

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.

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