Significant achievements have been made in the supervision of the source of "six-grip" medical devices in Shaoxing City

Since the beginning of this year, the Shaoxing Food and Drug Administration has paid attention to the quality of the original product, innovative thinking, and actively explored and adopted "six-grasping" measures. The city's medical device manufacturing enterprises have achieved remarkable results in supervision.

The first is to grasp daily supervision. There are 80 medical device manufacturers and 517 medical device registered products in Shaoxing City. The bureau's daily supervision coverage reached 100%, and it ordered the site to rectify 11 times, rectify 35 times within a time limit, and investigate and handle one case.

The second is to focus on special supervision. The bureau organized a special inspection on 14 medical electrical equipment manufacturers, 6 custom dentures, and 9 in vitro diagnostic reagent manufacturers. From the inspection point of view, all medical electrical enterprise testing equipment is in place and the accuracy basically meets the requirements; all denture enterprise personnel are stable, the operating procedures have been on the wall, the process flow sheet, waste disposal and other records are complete; all in vitro diagnostic reagent companies are required A quality management system has been established and operated, and most companies have kept records related to production inspections.

The third is to focus on supervision. For the two medical device manufacturers listed in the city, which are under the supervision of the state and the province, the supervisory contact person is assigned on the principle of territorial management. The supervisory contact person checks the risk point no less than once a month. Assessed and strengthened the dynamic supervision of the management of weak companies and high-risk products, and improved the quality of the company's sense of responsibility and quality management.

The fourth is to grasp product quality. The city has completed a total of 60 batches of medical devices for sampling this year, and the sampling coverage for domestic medical dressing companies has reached 100%. At the same time, the Bureau increased the supervision and inspection of export products, and conducted spot checks on 30 batches of export products of 10 manufacturing companies for online filing and export free sales certification.

The fifth is to grasp the quality system. The Bureau continued to fully implement the implementation of the “Medical Device Manufacturing Quality Management Regulations” and “Implementation Rules for Aseptic Medical Devices”, and went deep into the enterprise for policy guidance and technological transformation, especially for Shaoxing Zhende, Fuqing, Youtegel, and Shangyuxin. The enterprises such as Yueshang are faced with the situation of original site reconstruction or relocation. The Bureau intervened in advance and provided technical guidance for the company's purification design drawing review, equipment selection, license and product declaration in accordance with the requirements of the “Code”. The city has newly increased and expanded 6 medical device manufacturers and developed 127 new products.

Sixth, we must focus on corporate training. The Bureau has organized relevant experts to organize various trainings for medical device companies. In June this year, the Bureau held a training course for diagnostic reagent manufacturers in Xinchang County to conduct special training on clinical trials, product testing, performance evaluation, and data reporting of in-vitro diagnostic reagents. In October, it produced and operated all medical devices in the city. The unit has carried out the "Measures for Medical Device Recall Management (Trial)" training, fully implemented the recall system, and strengthened awareness of the first person responsible for the company, awareness of regulations, and awareness of the crisis.

In the next step, the Shaoxing Municipal Bureau will continue to strengthen the supervision of the source of medical devices, correctly handle the relationship between supervision and service, supervision and development, and regulate and promote the development of the medical device industry in Shaoxing to serve the healthy and sustainable development of the medical device industry in Shaoxing.