Constantly changing laws and increasing regulations complicate the process for first time applicants, as well as for companies familiar with the SELO license. This is because the CML legislation is quite young and frequent adjustments are made.
Although CML regulations share similarities with
these regulations have been deemed insufficient, and subsequently supplemented by Chinese specifications. Licensing takes place according to current TSG regulations and GB standards. These include the TSG Z0004-2007 – Basic Requirements for Special Equipment Quality Assurance System on Manufacture, Installation, Alteration and Repair and the TSG 07-2019: Regulation for Production and Filling Licensing of Special Equipment.
These regulations should be implemented in the applicant’s own company and recorded into a handbook. Other Quality Management Handbooks (QMH) are not accepted by the Chinese authorities unless they perfectly match the Chinese requirements. A quality Handbook according to DIN EN ISO 9001 or TSG Z00004-2007 is no longer sufficient. The QMH must comply with the Chinese regulations according to TSG 07-2019 and must be available in English. As a result of factory inspections and the growing experience of Chinese inspectors, Chinese authorities - such as AQSIQ, SELO and the CSEI institute - further develop their existing regulations and standards. Standardized procedures simplify the inspectors’ job. However, abiding by such procedures and facilitating inspections is time consuming and often involves misunderstandings due to language barriers and cultural differences. Please find additional information on the SELO-License using the following link - free Know-How – or contact us via phone/email.
