Mar 17, 2022

Medical device market regulators in China have issued several guidelines and updates in recent weeks covering issues such as registration of additive manufacturing and 3D printed devices, recordkeeping requirements for low-risk medical devices and in vitro diagnostic (IVD) products, and compilation of product technical requirements.

Plus, the Chinese National Medical Product Administration (NMPA) has provided updates regarding efforts to develop national standards for medical device safety and performance.

(All links to regulatory documents below are in Chinese.)

CMDE guidelines for 3D-printed medical device manufacturers

First, China’s Center for Medical Device Evaluation (CMDE), a division of the NMPA that provides technical evaluation of devices, has issued new guidelines covering registration of additive manufactured devices including polyetheretherketone implants; research on additive manufactured metal implant physical and chemical properties; and registration of laser selective melting metal materials for additive manufactured prosthodontic devices.

Revised Class I device record filing guidance

Next, the NMPA has opened a consultation period for revised guidance on Class I medical device record filing requirements. The revisions hew more closely to current NMPA regulations for medical devices and IVDs. (The consultation period ends March 31, 2022.)

Updated medical device standards from NMPA

Chinese regulators have also published a report on medical device standards development over the course of 2021. According to the report, the NMPA published 35 national standards, 146 medical device industry standards and three revisions to existing medical device standards last year.

NMPA 2022 medical device inspection plan

The NMPA has also published its National Medical Device Sampling Product Inspection Plan for 2022, which lists device types the regulator plans to inspect as well as associated rationales for inspections, i.e., compliance to mandatory standards or technical requirements. The plan also identifies relevant sampling and re-inspection institutions along with specific requirements for re-inspections.

Product technical requirements for medical devices

In addition, the NMPA has issued new guidelines to help medical device and IVD registrants compile their product technical requirements (PRTs). The guidelines cover required contents of PRT submissions, including device classification and performance indicators.

Learn more about Chinese medical device and IVD regulations at Emergo by UL:

  • China NMPA medical device registration and approval consulting
  • Medical device clinical and testing requirements assessment for China
  • Whitepaper: China NMPA medical device registration
  • Webinar: Medical device registration in China

Author

  • Stewart Eisenhart

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