To sell medical devices in the Chinese market, the following conditions must be met:
- NMPA Certification: Obtain approval from the National Medical Products Administration (NMPA) by submitting necessary documentation and passing inspections or testing if required.
- Local Representation: Foreign manufacturers must appoint a local agent or distributor in China.
- Quality Management System: Compliance with ISO 13485 or a similar quality management standard is necessary. The manufacturer's quality system should align with Chinese regulations.
- Clinical Trials: Depending on the device classification, you may need to conduct clinical trials within China to demonstrate safety and efficacy.
- Labeling and Documentation: Ensure product labeling meets Chinese requirements, including Chinese language labels, and prepare comprehensive product documentation in line with local regulations.
- Customs and Import Regulations: Comply with Chinese customs regulations and import requirements, including proper registration and documentation for importation.
Meeting these conditions ensures compliance with Chinese regulations and facilitates the smooth introduction of medical devices into the market.
Contact Us:
Whatsapp or Wechat:+86 15816864648;email address:hito.lin@grzan.cn
.jpg)