On 19 May 2020, the National Medical Products Administration(NMPA) of China has formulated a document to evaluate the changes in raw materials of passive medical device products.
A medical device that has been approved for listing may often go through changes in terms of production equipment, raw materials, production process, inspection methods, and quality control standards.
As required by the medical device production quality management system, the changes in materials, product functions, and parts may affect the effectiveness and safety of the medical devices.
In order to address this issue, the guideline aims to provide a systematic risk analysis of the raw material changes and guide registrants in terms of regulating the design, registration, and quality control of related products.
The document is not applicable to changes in the scope of application, specifications, and models of passive medical device products.
As part of the risk management procedure, registrants can refer to the document requirements for medical device safety and effective basic requirements, medical device design and development related procedures, and other documents for evaluation.
The information that is incorporated in the guideline includes the decision-making evaluation path change. The process is initiated by judging the form of a material change, conducting biological evaluation, laboratory research, animal experimental and clinical evaluation, and risk assessment and control.
The evaluation process of the raw material change in a passive medical device product is presented through a flowchart in the said document.
This document serves as a guide for registrants and reviewers and excludes any administrative matters involved in registration approval, nor is it enforced as a regulation.
For more information on the guideline, you may refer to http://www.nmpa.gov.cn/WS04/CL2138/377515.html