China and the Export of PPE
This notification comes from AfA Regulatory Compliance Committee member Michael Ford of BDP for those with customers ordering personal protection equipment (PPE) from China:
China 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;
- 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 as follows (only available in Chinese):
The self-declaration and statement as follows (only available in Chinese):
The qualified medical devices which are CFDA certified can be found
or refer to the latest information published on
official website (only Chinese version available).