Dalian actively supervised the quality and safety of Novel Coronavirus antigen testing reagents

2022-06-02 0 By

The Chinese quality network For seriously implement the state food and drug administration and drug administration in liaoning province will be coronavirus antigen detection reagent quality and safety supervision, strengthen the will be coronavirus antigen detection reagents, product quality and safety on March 22, dalian market supervision bureau issued by the affairs of the business will be coronavirus antigen detection reagent quality safety work notice,All district, city and county market regulatory bureaus are required to fully fulfill their responsibilities of local supervision, strengthen the quality and safety supervision of novel Coronavirus antigen testing reagents in the operation process, and urge enterprises to fulfill their main responsibilities and strictly observe the bottom line of quality and safety.According to the Notice, during the epidemic prevention and control period, retail pharmacies and medical device operators with drug or medical device business licenses and corresponding storage conditions can sell novel Coronavirus antigen testing reagents offline.Novel Coronavirus antigen testing reagents shall not be sold by drug wholesale enterprises that have not obtained a business license for medical devices or enterprises that have only obtained the registration certificate for business operation of category II medical devices.At the same time, retail pharmacies and medical device operating enterprises shall make purchase inspection and sales records in accordance with the requirements of the Medical Device Operating Quality Management Standards.Sales (including network) issued by sales credentials, completes the sales records, to facilitate quality traceability, focus on whether sales product manuals indicate the individual consumers to use, etc., a professional manual indicate the use of the new champions league antigen detection reagent can’t in retail pharmacies, medical equipment management enterprise retail sales (including network).To be equipped with appropriate facilities and equipment, ensure that the transportation and storage conditions of products meet the labeling requirements of labels and instructions, and regularly check the inventory of products.Consumers should purchase novel Coronavirus antigen testing reagents from legally qualified medical device registrants and manufacturers, and pay special attention to whether the novel Coronavirus antigen testing reagents sold have been registered and approved by the State Medical Products Administration and have qualified certificates.In addition, the third category of medical device operators that have obtained the registration of online sales of medical devices can engage in the online sales of Novel Coronavirus antigen testing reagents, and the business scope indicated in the business license of their medical devices shall include 6840 in vitro diagnostic Reagent (refrigerated and frozen) or 6840 in vitro diagnostic Reagent (non-refrigerated and frozen).The business license of medical devices shall be prominently displayed on the main page of the website and the registration certificate of Novel Coronavirus antigen testing reagent and other information shall be displayed on the product page.Enterprises not qualified for online sales of medical devices shall not sell novel Coronavirus antigen detection reagents online.From March 25th, some pharmacies in Dalian began to sell novel Coronavirus antigen testing reagents. The Municipal Market Supervision Bureau immediately carried out special supervision and inspection on the quality and safety of reagents.Recently, Wang Wentao, deputy Director of Dalian Municipal Administration for Market Regulation, led a team to visit Dalian Sunshine Pharmacy Co., LTD., to learn about the current business situation, operation mode and future development ideas of the company, and to put forward requirements for the import and sales of novel Coronavirus antigen testing reagents.Wang wentao said that enterprises should strictly implement the relevant regulations of Dalian on epidemic prevention and control, strictly control the purchase inspection, storage, transportation and sales management of products, earnestly implement the main responsibility of enterprises, and ensure the quality and safety of novel Coronavirus antigen testing reagents.Law enforcement officers also supervised and checked the Novel Coronavirus antigen testing reagents sold in The Gaoji Yi Chuntang Xi ‘an Road store and Chunliu Store and the Qingni Branch of Guoda Pharmacy, focusing on the legal qualification of the products, the qualification of the supplier, purchase and acceptance records and sales records, product specifications, etc. No problems were found.Dalian Market Supervision Bureau reminds the general public:For novel Coronavirus antigen detection reagents, they should be purchased from retail pharmacies with drug business licenses or medical device business enterprises with medical device business licenses. Sample collection and antigen detection shall be carried out in strict accordance with the instructions. Meanwhile,In accordance with the novel Coronavirus Antigen Detection Application Protocol (Trial) (JCP no. 21 2022), test results and waste disposal shall be carried out.(Wang Shizhen)