Is it true that the medical equipment sold by Tmall Medical Museum? There are many people who look at the purchase, and I don't know if it is formal. People who know can guide me.

The OEM you refer to is professionally called OEM mode. This mode of production is allowed by the drug administration, that is, a legal mode of production.

As you described, its registration information has been found on the website of the Food and Drug Administration, which proves that the product was once allowed to go on the market. However, if the validity period has expired, the certificate is invalid. At most, it can only prove that it has been allowed to go public.

According to the Regulations on the Registration of Medical Devices, the registration of medical device products is divided into three categories: first registration, re-registration and change registration. For products that are about to expire, enterprises should apply for re-registration six months before the expiration of the registration certificate.

Meichuang Consulting-professional medical device registration agency, IVD registration agency, CRO clinical trial