In order to improve the qualification management of inspection and testing institutions and to stimulate the examination market, the China State Administration for Market Regulation (SAMR) issued a notification on the reform measures for the required qualifications of inspection and testing institutions on May 7, 2019, and publicly solicited opinions.
In this notification, the "Notice on Further Promoting the Reform of the Qualification Permit for Inspection and Testing Institutions (Draft)" and the "Administrative Measures for the Notification of Qualification Recognition of Inspection and Testing Organizations (Draft)" were issued. The gist of this reform can be summarized through the following five aspects: 1) The cancellation of the previous “Quality Assurance Agency Qualification Certification”; 2) Implementation of the notification commitment system; 3) Implementation of the self-declaration system; 4) Integration of the inspection and testing institution qualification certification certificate, and 5) Gradually establishing that one testing organization only possesses “one certificate” instead of multiple ones.
This notification is especially good news for medical device type testing, as it implies that the NMPA will not only accept testing reports issued by the officially designated agencies in the future. Combined with the announcement from the SAMR earlier this year regarding the requirements for all testing organizations to upload test reports to SAMR, it can be observed that the Chinese government is gradually adjusting the direction of supervision of testing institutions. That is, opening up for more and more 3rd-party institutions to join the inspection market, while SAMR simultaneously strengthens on supervision.