Look at the medical device registration certificate number(like:bandages
Check whether the registration certificate number is arranged correctly. The medical device registration certificate number is arranged as: A (A1) (Food) Drug Administration Equipment (A2) AAAA3 No. A4AA5AAAA6; "A1" is the abbreviation of the registration approval department; "A2" Registration type; "AAAA3" is the year of approval for registration; "A4" is the product management category; "AA5" is the product variety code; "AAAA6" is the registration serial number; such as the "Disposable Urinary Catheterization" approved by the Jiangsu Food and Drug Administration in 2003 "Package", the correct way of arranging the registration certificate number is: Suyao Guanji (Examination) No. 2050036 2003, otherwise all are wrong. For example, the Lianshui Bureau seized the condom labeled as "Honeymoon Fun" produced by Shenzhen Yimeisi Health Products Co., Ltd., and its registration number was Shenyao Guanqi (zhun) Zi 2001 No. 39200367, which was verified as a counterfeit. To
Check whether the registration form of the registration certificate number is correct. The registration forms are divided into: "Approval, Advance, Permit, and Trial". (Quasi): refers to domestic equipment; (in): refers to overseas equipment; (permission): refers to equipment in Hong Kong, Macao, and Taiwan; (trial): refers to trial-produced equipment. For example, if the Lianshui Bureau identified a catheter produced by a Hong Kong company, its registration certificate (A2) was marked with the word "in", and it was verified as a counterfeit. ToSee whether the registration certificate number has expired The validity period of the medical device registration certificate is usually 4 years, and the validity period of the registration certificate for trial production products is two years. For example, the “Romantic Lover” condom seized by Lianshui Bureau is marked as a “romantic lover” condom produced by a latex factory in Guilin, and its “Registration Year” (AAAA3) is marked as “1991”, and the “Production Date” is July 2003, which is verified as Counterfeit.
ToSee whether the product management category in the registration certificate number is correct. The production of Class III devices requires approval, the production of Class II devices requires the approval of the provincial bureau, and the production of Class I devices requires the approval of the municipal bureau. The third type of device must be marked as "3" in the "product management category" (A4); the second type of device must be marked as "2" in the "product management category"; the opposite is all wrong. For example, the label seized by Lianshui Bureau is a single-use suction head produced by a medical device factory in Hanjiang, Yangzhou City, and its (A4) is marked as "1", and the management category belongs to the second-class medical device.
To Check whether the product variety code in the registration certificate number is correct. According to the medical device classification catalog, different varieties have different codes. For example, the code for disposable syringes is "15" and (AA5) should be marked as "15". If the registration form (A2) is (trial), then in the registration certificate number (AA5), the correct one should not be marked with "Product Variety Code" but the year of termination of trial production should be marked. For example, the “yellow rose” condom seized by the Lianshui Bureau was marked as a "yellow rose" condom produced by a latex factory in Dalian, and its (AA5) was marked as "68", while the condom variety code was "66" (registered before August 2002 as " 67”), which was verified as a counterfeit.