The market supervision bureau of city a found during the supervision inspection of B optical shop that B optical shop was operating a product with the name of hard contact lens washing solution (marked with manufacturer: C manufacturer, health license No.: xwxzz [2015] No. 0233, executive standard: Q / xx-wj03-423-3, batch No.: 19093003, production date: September 2019). The outer package of the product was marked with "composition: the solution is hard contact lens washing solution" Sterile buffer brine solution, containing sodium chloride, disodium hydrogen phosphate, polyhexamethylene biguanide, etc. Function: This product is specially used for lens washing in the nursing process of hard contact lenses (fluorosilicone acrylate silicone acrylate hard contact lenses), so as to improve the lens cleanliness, safety comfort of wearing glasses. The production license number, registration number other information of medical devices are marked. After the supervisors contacted the production enterprise C, the enterprise provided the health license for the production enterprise of disinfection products approved by the provincial health Health Committee of the place the enterprise is located in 2019, which indicates "production project: sanitary products, production category: contact lens care solution".

Differences in product quality

The supervisors have different opinions on whether the hard contact lens care solution is a medical device a disinfection product.

The first opinion is that the hard contact lens care solution should be managed according to the medical devices, the above products should be characterized as unregistered medical devices. In the catalogue of classification of medical devices (2002 Edition), in the classification of "ophthalmic optical instruments implanted in in long-term contact with the body" in "6822 medical optical instruments, instruments endoscope equipment", the management category of "corneal contact lenses (soft, hard, molded corneal contact lenses) nursing solutions" is listed, which is class III. It is clearly listed in "16 ophthalmic devices-06 ophthalmic orthopedics protective devices-02 contact lens care products" in 2017 edition of medical device classification catalogue. The products used for cleaning, disinfection, washing storage of contact lenses belong to the third category of medical devices. The intended use of the hard contact lens rinse in this case is similar to the intended use of the contact lens care products listed in the 2017 version of the medical device classification catalog, the product ingredients "contain sodium chloride, disodium hydrogen phosphate, polyhexamethylene biguanide, etc." the 2017 version of the contact lens care products in the 2017 version of the medical device classification catalog "take sodium chloride as the main effective ingredient The physiological balance of saline solution (about 0.9%) was similar. Therefore, the above-mentioned products should be the third type of medical devices, the registration certificate of medical devices should be obtained. The production sale of the above-mentioned products without registration should be characterized as unregistered medical devices.

The second opinion is that the hard contact lens care solution should be managed according to the disinfection product, which is a legal product. Hard contact lens washing liquid is used for hard contact lens washing, which has a cleaning effect does meet the definition of traditional Chinese medical devices in the regulations on the supervision administration of medical devices. In "2. Sanitary products" of the catalogue of disinfection products released in 2002, 1, 2 3 of the fourth contact lens care products are respectively contact lens care solution, contact lens preservation solution contact lens cleaner. The eighth (ninth) (tenth) of the "third, sanitary products" in Annex 3 "classification catalogue of production categories" of the regulations on hygiene license of disinfection product manufacturers "implemented on January 1, 2010 are contact lens care solution, contact lens preservation solution contact lens cleaner. Therefore, the product should be managed according to the disinfection product approved as a legal product.

Comprehensive judgment by detailed analysis

For the same product, the drug regulatory department classifies it as the third category of medical device management, while the competent health department includes it in the management of disinfection products. Whether it is used as medical device management disinfection product management, it needs to go through the corresponding approval. So, contact lens care products contact lens care solution, contact lens preservation solution, contact lens cleaner, etc. are medical devices disinfection products?

First of all, the perspective of product attributes. Contact lens care products, such as contact lens care solution, contact lens preservation solution contact lens cleaner, are products that can clean, disinfect, wash store contact lenses.

Article 76 of the regulations on the supervision administration of medical devices specifies the definition of medical devices. Medical devices refer to the instruments, equipment, instruments, in vitro diagnostic reagents, calibrators, materials other similar related articles directly indirectly used for human body, including the required computer software. Their effectiveness is mainly obtained by physical means, by pharmacology Immunology metabolism is obtained, although these methods are involved, it only plays an auxiliary role; its purpose is: (1) diagnosis, prevention, monitoring, treatment remission of disease; (2) diagnosis, monitoring, treatment, remission functional compensation of injury; (3) examination, replacement, regulation support of physiological structure physiological process; (4) life To provide information for medical diagnostic purposes by examining samples the human body.

Article 45 of the measures for disinfection management stipulates that disinfection products include disinfectants, disinfection instruments (including biological indicators, chemical indicators packages of sterilization articles), sanitary products disposable medical products.

the composition, structure, function function of contact lens care products, the