China's Ministry of Commerce (MOC), General Administration of Customs (GACC), and National Medical Products Administration (NMPA) issued a joint announcement [2020 No.5] to impose additional quality control measures on exports of certain medical supplies, effective from April 1, 2020.
Impacted products include:
- Coronavirus test kits;
- Medical/Surgical masks;
- Medical/Surgical isolation gowns;
- Ventilators;
- Infrared thermometers.
Additional control measures apply when exporters declare to China customs:
- Registration Certificate for Medical Device Products should be provided and verified with export declaration;
- Self-declaration on a valid Registration Certification for Medical Device Products issued by NMPA, along with;
- A statement showing commitment to comply with the destination country’s quality standards is required.
The original announcement (only available in Chinese) can be found here.
The self-declaration and statement (only available in Chinese) information can be found here.
The qualified medical devices which are CFDA certified can be found here or refer to the latest information published on the NMPA official website (only available in Chinese).
Sources: China's Ministry of Commerce, General Administration of Customs, and National Medical Products Administration
