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On 18. February 2019, the Chinese market supervisory authority SAMR (State Administration for Market Regulation of the Peoples Republic of China) announced further measures and regulations in the area of special and pressure equipment. A simplification is being sought, similar to the one already initiated for the CCC (China Compulsory Certification) in 2018.This affects holders of the China Manufacturer License (CML) from the China Special Equipment Licensing Office (SELO). They include among other things pressure equipment (containers, pipes), boilers, valves, bursting discs, freight cranes, lifts, cable cars, special vehicles and amusement facilities.Based on the current official information, we can summarize the changes as follows:

1) Optimization measures for acquiring the administrative license for special devices

• Reducing the time required for approval (provided that the application has been submitted correctly and in the complete form) and simplifying the application documents.
• The manufacturer is to be given the option of self-declaration for the licence renewal.
• Simplification of the certificate renewal procedure for special equipment licensees.
• Official fees for the application will be subsidized by the Chinese government.
• Further digitization of the application procedure.

2) Intensification of surveillance measures

• More frequent inspection of manufacturers after receiving the licence due to quality defects found during factory inspections or reported to the authority. This also includes unannounced inspections.
• Stricter review and inspection of relevant safety specifications during type testing and factory inspection.
• For manufacturers who obtained a licence by self-declaration, the licence will be withdrawn by the authority if untrue content is found in the application documents.
• Publication on the Internet of information on the licence holder about accidents caused by quality problems and the discovery of false information. For Chinese companies, this will also have an impact on their point in the PRC's Social Credit System.

The self-declaration for the license extension will come into force on 01. June 2019.Other regulations are to be implemented from 01. March 2019.Many details on the concrete implementation have not yet been published by the authority SAMR and impair the ability of the responsible authority SELO to operate.It is also not yet known whether all of the above-mentioned points will also apply to foreign licensees or applicants from the time of their entry into force.

Related news from us:

https://cisema.com/en/news-en/ccc-en-2/china-ccc-certification-obligation-lifted-for-numerous-products/

In the article A fortunate opportunity? Navigating Chinese regulation challenges to ensure success Anna Fischer from Cisema Hong Kong sets out the key challenges that foreign manufacturers of medical devices face in obtaining approval for and access to the Chinese market. Read the article on MedTech ENGINE.

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