On March 31st, 2020, China issued the “Notice Regarding Orderly Development of Medical Goods Exports applicable to the exports of Private Protective Equipment (“PPE”)”, effective April 1, 2020 (the “Notice”).
The Notice is intended to insure the quality of PPE by requiring that Chinese manufacturers of PPE have proper certifications by the State Food and Drug Administration (“SFDA”) and that the manufacturers be listed in the national medical products registry maintained by the SFDA.
The PPE categories covered include the following types of products for fighting coronavirus which require verification:
Coronavirus Testing Kits
Medical Protective Outfits/Gowns
Medical Protective Masks
Surgical Masks
Disposable Medical Masks
Ventilators and
Infrared Thermometers
The verification involves not only testing the specific products but also verifying the manufacturers’ hardware, personnel qualification and process by the SFDA.
All such PPE exports will be checked at export customs control points to insure that proper paperwork is presented. The purpose of this Notice is to protect consumers and recipients of exported Chinese PPE from sub-standard or defective products. This memo summarizes the requirements to insure that foreign buyers select proper suppliers prior to placing purchase orders. This memo focuses on testing kits only as an example. The requirements for other PPE categories should be specifically checked against the specific regulations.
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