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.
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:
For the English version of the National Medical Device Quality Audit Procedure or any documents mentioned above, please email info@ChinaMedDevice.com.
This Procedure includes the following steps:
The document also specifies that:
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.