entry china market requirements service provider [Video]

For European baby-faced needle products or other medical aesthetic products to enter the Chinese market, they must meet a series of stringent regulatory requirements and certification processes to ensure their safety and efficacy. Below are some key requirements:

Registration with the National Medical Products Administration (NMPA): All imported medical devices and cosmetics, including medical aesthetic injection products, must first obtain approval from China’s National Medical Products Administration (NMPA, formerly CFDA). This involves submitting detailed product information, clinical trial data, quality management system certifications, among others, to demonstrate compliance with China’s relevant laws, regulations, and technical standards.

Clinical Trials: For some products, particularly new or those entering the Chinese market for the first time, clinical trials may be required in China to validate their safety and effectiveness in the Chinese population. These trials must adhere to NMPA guidelines and be conducted after obtaining necessary ethical approvals.

Good Manufacturing Practice (GMP) Compliance: Manufacturers need to prove that their production processes comply with Good Manufacturing Practices (GMP), whether at overseas or domestic facilities.

Labeling and Instructions for Use: Product labels and instructions must be prepared according to Chinese regulatory requirements, including Chinese language content, clearly stating usage methods, contraindications, precautions, etc.