September 17, 2018
The National Medical Product Administration (hereinafter referred to as NMPA) has released a list of medical device industry standards covering the new and amended standards from August 7th. Notable standards included in this exhaustive list, among others, include "Electrical safety standards for medical electrical equipment", "the unique identification system for medical devices", and other mandatory standards for medical devices and in vitro diagnostic reagents.
It is noteworthy that many commonly encountered standards are still included in the list. Active medical devices for instance, still includes the basic "Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standards: Electromagnetic Disturbances Requirements and Tests".
In addition, Shandong Jinan Inspection Institute will also be developing a number of Standards related to biocompatibility testing that includes the following:
1. "Medical equipment Genotoxicity test - Part 6: In vitro mammalian cell micronucleus test"
2. “Medical device immunogenicity evaluation method - Part 6: Determination of spleen lymphocytes by flow cytometry Cell subpopulations",
3. "Medical device and platelet interaction test - Part 2: In vitro platelet activation test",
4. "Medical device complement activation test - Part 3: Determination of complement activation products",
5. “Medical device biology evaluation Medical device potential nerve Guidelines for the selection of toxicity evaluation tests."
The last items in the list, but also regarded of high importance, are related to the Medical Device Unique Identification System (UDI) which shall be implemented by the end of 2018 or 2019. This shows that NMPA implements the UDI imperatively.
We hereby recommend that all manufacturers which have already entered or are about to enter the Chinese market shall pay close attention to these changes in China's national and industry standards, and prepare relevant tests in advance to facilitate the renewal registration.