Check if the labeled medical device registration number is expired
Mainly depends on whether there are more than four years between the "approved registration year" and the "production date" in the labeled medical device registration certificate number. Article 14 of the Regulations on the Supervision and Administration of Medical Devices stipulates that the medical device registration certificate is valid for 4 years. Such as: labeling degreased cotton produced by Chaozhou Xiongda Sanitary Material Factory, medical device registration certificate number labeling "Guangdong Drug and Drug Control Device (Qualified) 2000 No. 1640118", and "production date" as August 2, 2005, you may suspect that the product is in trouble.
Check if the product management category in the labeled medical device registration certificate number is correct
The production of three types of medical devices should be approved by the State Food and Drug Administration, the production of two types of medical devices should be approved by the provincial drug administration, and the production of one kind of medical devices should be approved by the Municipal Drug administration. For example, three kinds of medical devices implanted into human body, such as disposable infusion device, syringe and medical sheep intestine thread, must be labeled "3" at "Product Management Category" (X4); two kinds of medical devices, such as rubber condom and thermometer, must be labeled "2" at "Product Management Category"; one kind of medical devices, such as medical infusion sticker and stethoscope, should be labeled "Product Management Category". It must be labeled "1"; conversely, it is wrong.
Zhejiang Geyi Medical Instrument Co., Ltd.
Address: No. 190 Chutian Road, Xixing Street, Binjiang Zone, Hangzhou, Zhejiang, China
Contact: Desiree Shu
Mobile: +86 15868407021