How To Distinguish The Truth From The False Of Medical Devices (I)

Feb 27, 2019
How To Distinguish The Truth From The False Of Medical Devices (I)


Check if the registration form in the labeled medical device registration certificate number is correct

The forms of registration are classified as "Accurate, Advanced, Permitted and Trial". "Quasi" refers to medical devices manufactured in China; "Jin" refers to medical devices manufactured abroad; "Xu" refers to medical devices manufactured in Taiwan, Hong Kong and Macao; and "Trial" refers to medical devices manufactured on trial. For example, if the manufacturer of Otolaryngology surgical instruments labeled on the package of a medical instrument is XXX Company of Hong Kong, the correct registration form (X2) in the registration certificate number should be the word "permitted"; if the manufacturer labeled on the package is XXX Company of the United States, the correct registration form (X2) in the registration certificate number should be the word "entering". In addition, there are "trial" products before August 9, 2004. The registration certificate is valid for two years. After August 9, 2004, there are no "trial" products.


Check if the numbering of the labeled medical device registration certificate is correct

Article 5 of the Measures for the Registration and Management of Medical Devices stipulates that the numbering of medical device registration certificates shall be as follows: (X1) Drug Control Devices (X2) XXXXXX3 X4XX5XXXX6; "X1" is the abbreviation of the place where the registration and approval department is located; "X2" is the form of registration; "XXXXXXXX3" is the year of approval and registration; "X4" is the category of product management; "XX5" is the product variety code; "XX6" is the registered pipeline. Number. For example, "medical sheep intestine line" approved by the State Administration of Pharmaceutical Supervision in 2001, the correct registration number arrangement method is "National Drug Control Device (Qualified)" No. 365 0168, 2001. For example, "medical silk thread" approved by Shanghai Pharmaceutical Regulatory Bureau in 2000, the correct registration number arrangement method is: Shanghai Pharmaceutical Control Equipment (Quasi) 2000 No. 265888. In addition, attention should also be paid to the registration number arrangement issued by the State Food and Drug Administration after June 20, 2003 as follows: (X1) Food and Drug Monitoring Device (X2) XXXX3 X4XX5XXXXXX6. Such as: high-quality high-grade condom for barbaric girlfriend produced by Qinhuangdao latex factory, registration number: Jiyaguancheng (quasi) No. 267,0128, the product registration number marked on the condom package has no year of approval, and the "instrument" in the medical equipment registration certificate is printed as "city", which is a false registration number.


Zhejiang Geyi Medical Instrument Co., Ltd.

Address: No. 190 Chutian Road, Xixing Street, Binjiang Zone, Hangzhou, Zhejiang, China

Contact: Desiree Shu 

Tel: +86-571-86676319

Fax: +86-571-86676306

Mobile: +86 15868407021

E-mail: desiree@geyi-medical.com