NMPA seeks comments on the new Quality Inspection Sampling Procedure for Medical Devices

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NMPA seeks comments on the new Quality Inspection Sampling Procedure for Medical Devices

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NMPA published the draft document of National Medical Device Quality Inspection Sampling Procedure on October 13, 2020 for feedback. Feedback needs to be submitted by November 12, 2020.

The National Medical Device Quality Audit Procedure is drafted based on the Regulations on Medical Device Audit and Administration and the Measures on the Medical Device Quality Audit and Administration.

Legal Representative’s Responsibilities

China Med Device is a certified NMPA legal representative. We can help you fulfill the requirements of quality, manufacturing and post-market surveillance.

Legal representative will play a far more important role when the document is finalized:

  1. Within 15 working days after requesting samples for inspection, the medical device registrant or legal representative for imported device must send required products and supporting necessities to the inspection agency
  2. Inspection agency will contact registrant or legal representative for any missing materials
  3. Sampling can be conducted at the registrant’s manufacturing site(s) or the site of legal representative
  4. Legal representative and which province the legal representative is located in shall be identified in the Sampling Report
  5. Legal representative OR registrant can sign off on the Result Delivery Notice
  6. Registrant and legal representative shall cooperate with recall activities and release relevant actions and information if any defects found
  7. Legal representative and registrant will be responsible for corrective measures regarding identified Potential Risks and Complaints

For the English version of the National Medical Device Quality Audit Procedure or any documents mentioned above, please email info@ChinaMedDevice.com.

Sampling Procedure

This Procedure includes the following steps:

  • Protocol formulation
  • Implementation and taking samples of selected products
  • Re-inspection
  • Inspection result release;
  • Objection and appeal,
  • Data analysis, and
  • Penalization.

Highlights from the Document

The document also specifies that:

  1. Record will be kept by NIFDC for five years
  2. Penalties for defective devices include recall, suspension of sales, suspension of production, forced enterprise closure
  3. All documents from inspection plan, product sampling, repeal, CAPA will be recorded into Sampling Control System (https://www.nifdc.org.cn/nifdc/fwzn/gjcjglxt)

The 22-page document also clarifies the responsibilities of the national, provincial NMPA, and National Institute of Food and Drug Control (NIFDC) respectively.

NMPA also requires submission of a Periodic Risk Assessment Evaluation Report. This requirement is specified in Decree No. 1 Administrative Measures of Medical Device Adverse Event Monitoring and Re-evaluation (published on Aug 13, 2018, effective since Jan 1, 2019).

The quality audit protocol and audit product list are formulated under the Measures on the Medical Device Quality Audit and Administration. Please contact us Info@ChinaMedDevice.com for an initial consultation.