Dear certified organizations,

Converted equivalently from ISO 13485:2016 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes, YY/T 0287-2017 for the pharmaceutical industry (hereinafter referred to as “Old Industry Standard”) has been transitioned to GB/T 42061-2022, the recommended national standard (hereinafter referred to as “New National Standard”). The standard was released on October 12, 2022, and will take effect from November 1, 2023. To facilitate the conversion of the standard, relevant arrangements are made as follows:

CQC has fully started the conversion of the standard, and the transition period will be from the date of this notice to October 31, 2023. For the benefit of clients, CQC will not accept the certification application of the Old Industry Standard from November 1, 2023. As the standard is transitioned from the pharmaceutical industry standard to the national recommended standard, with the scope of ISO 13485 applied in the industry chain expanded, and the influence of ISO 13485 certification enhanced, the certified organizations are recommended to apply the New National Standard before the abolition of the Old Industry Standard.

CQC begins to accept the certificate conversion application from February 24, 2023. The certified organizations can complete the application in two ways

1) combined on-site audit. The certified organizations can choose the latest surveillance audit or recertification audit for the certificate conversion.

2) document audit. The certified organizations can fill out the Certificate Alteration Application Form and submit other written materials if such information as name, address, enterprise size and the certification process has not changed since the end of the last audit.

For more details of the conversion, please contact the companies of the China Certification & Inspection Group. Contact information of each company can be found on: https://ccic.e-ciie.com/cn/2018/branch_1016/2.html.