Bryan Gilburg - China

“The NMPA has been highly active in 2020 updating many of their regulations, standards and processes. Contact us to identify how some of the new changes could affect your time and costs. ”

Bryan Gilburg
Asia Actual 

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CHINA: REGULATORY AND COMMERCIAL UPDATES

Published August 14, 2020

Extending Digital Certification (CA) Certificates of Medical Device Registrations Online

On May 10, 2019, the Center for Medical Device Evaluation (CMDE) launched the digital certification (Certificate Authority, CA) program used in the eRPS system for medical device registrations. The CA certificates are valid for one year and for applicants with expiring CA certificates, CA certificate holders can apply for a 1-year extension online. The CMDE doesn’t charge for this.

NMPA’s 2020 Medical Device & IVD Industrial Standards Revision and Development Plan

NMPA issued their annual medical device & IVD industrial standards revision and development plan on May 19, 2020, titled the Medical Device & IVD Industrial Standards Revision and Development Plan for 2020. There are 86 medical device & IVD standards that will be revised or developed. Among the 86 standards, 9 are mandatory standards and 77 are recommended standards; 34 are revisions of current standards while 52 are newly developed.

The mandatory standards apply to the following products:

  1. Breast implants (Revision)
  2. Radiofrequency ablation for the liver (Revision)
  3. Electrical respiratory equipment (2x New)
  4. Robotic assisted surgical equipment (New)
  5. Medical robots for rehabilitation, assessment, compensation or mitigation (New)
  6. Clinical thermometers for thermometry (Revision)
  7. Active implantable – circulatory support devices (New)
  8. Intraocular Lenses (Revision)

If you would like English translation of this Plan and to see if they are applicable to any of your devices, please reach out to further discuss.

Administrative Regulation for Import Medical Devices Urgently Needed in Boao Lecheng International Medical Tourism Pilot Zone of Hainan Free Trade Port

On June 2, 2020, the Hainan government issued the “Administrative Regulation for Import Medical Devices Urgently Needed in Boao Lecheng International Medical Tourism Pilot Zone of Hainan Free Trade Port.” This replaces the previous regulation issued in April of 2018.

For devices that are urgently needed but haven’t been approved by the NMPA, manufacturers can apply through the local Hainan provincial FDA. This will speed up the product approval process and make sure patients in the pilot zone can receive the most advanced treatment available in the world. To be approved, manufacturers will need to work directly with at least one of the medical institutions in the zone where there is an urgent need the device must be approved by FDA or country of origin.

If you have any question or would like to read the full regulation in English, feel free to contact us.

Manufacturers interested in marketing their innovative products in Hainan’s Pilot Zone can learn more by viewing our article “China Changes Clinical Data Requirements for Medical Device Registration”. Contact our team to learn more about innovative product marketing strategies throughout the SE Asia region.

Class III High Risk Medical Device List Adjusted

In August 2014, NMPA released a list of Class III high risk device list that would need NMPA approval prior to starting a clinical trial in China. Originally, there were 8 major items but in June of 2020, NMPA released a revised version, which reduced the list to 6 major product types.

The Class III product categories that require clinical trials in China include implantable cardiac rhythm management equipment, implantable ventricular assisting systems, implantable drug infusion equipment, artificial heart valves and intravascular stents, tissue engineering medical products containing live cells, and absorbable long bone internal fixation implantable devices.

Process for Class II Applications that are Later Confirmed as Class III Medical Devices During the Technical Review

For medical device applications that are originally applied for as Class II but are later identified as a Class III during the CMDE technical review, a rejection letter will be issued and the review process will be terminated. When the applicant resubmits the registration application as Class III medical device, the copy of the rejection letter will need to be included and the applicant will only need to pay the difference between Class III and Class II registration fees. To expedite time to market, it’s important to correctly classify your product up front.

Actual has experienced personnel that can help determine the classification and even reach out to the NMPA for their feedback for novel products.

Asia Actual Can Help Navigate the Evolving Regulatory Process in China

The NMPA has been highly active in 2020 updating many of their regulations, standards and processes. If you are considering entering the Chinese market, please contact us to identify how some of the new changes could affect your time and costs.