Undertake overseas production site inspection | Strict control of imported medical equipment safety risks

Pharmaceutical Network February 22 hearing To prevent the risk of imported products, the State Food and Drug Administration to increase the scope of overseas production site inspections and efforts in the field of medical equipment, only in 2017, has the United States, Germany and other 10 countries 46 imported products from 24 medical device manufacturers (including 6 in trial products) conducted field inspections on overseas sites involving orthopedic implants, vascular stents, staplers, vascular catheters, dressings and in vitro diagnostic reagents.

On January 17, 2018, the official website of China's State Food and Drug Administration announced the results of on-site inspection of 9 overseas manufacturers of medical equipment enterprises, which is the first time that the results of on-site inspection of overseas production of 5 medical equipment enterprises were announced on November 28, According to the inspection results, the above enterprises are mainly distributed in countries and regions with advanced technological level in the United States and Europe, and their defects and problems are mostly related to product registration, plant and facilities, Quality control, process flow, purchase , Document management, etc. Among them, two companies were halted because of the existence of irregularities.

According to reports, in 2015, the State Food and Drug Administration staff organized on-site inspections of two medical equipment manufacturing enterprises overseas. In 2016, a total of 33 varieties of 19 medical device manufacturing enterprises in 8 countries were inspected on site In 2017, production site inspections were conducted on 46 products (including 6 audited products) from 24 enterprises in 10 countries such as the United States, Germany and the United Kingdom, etc. The number of inspections in 2018 will reach more than 30 and the inspection intensity Increased year by year.

'From the perspective of the entire operation, the first year was a pilot project, so we chose Johnson & Johnson and Medtronic, the leading players in technology and management, mainly on the basis of learning experiences and exploring ways of working. The following year, the scope of inspection was expanded The results of the inspection were not released until the end of 2017. The results of overseas production site inspections were not announced on the website of the SAIC, indicating that the overseas inspection of medical equipment in China has been put on the track. 'The State Food and Drug Administration's Food and Drug Audit and Inspection Center (hereinafter referred to as' Verification Center ') Wang Aijun, Director of the Medical Device Verification Department, said that the results of overseas production site inspections of 24 enterprises examined in 2017 will be announced one after another on the Internet and the penalty will be punished for any illegal activities that actually exist in the enterprise.

According to the "Regulations on Overseas Inspection of Medical Devices" issued by the State Food and Drug Administration on December 9, 2016, the State Food and Drug Administration shall complete the annual review of the overseas inspection of medical devices for the next fiscal year by November 30 of each year, including the annual Check the variety of raised, confirmed, approved, convened to be inspected varieties of manufacturing enterprises ventilation, etc. Verification Center according to the characteristics of product categories selected qualified inspectors, combined with the production area, inspection time, the preparation of annual inspection plan, reported that the national food and drug Supervision Department of Medical Device Supervision Division, after the approval of the leadership in charge of the General Administration, Department of International Cooperation Department.

'All enterprises included in the annual inspection plan, to open the gas will be to determine the specific product in which country, the specific production status of the product, etc.' Wang Aijun said the inspection plan is not easy to formulate.Many times the product's foreign registered address and release Address is not in one place, need to determine the main production processes in order to determine the inspection plan.

According to reports, the inspection plan set down, the inspector also need to determine the comprehensive consideration of many factors.

'Overseas inspection, the qualifications of inspectors, staffing, inspection methods and methods are different with the territory.' Wang Aijun told reporters that each species or business generally check 4 to 5 days, each group usually assigned 3 to 5 inspectors , Covering testing, registration, review, system inspection and other professionals, and sometimes including the State Food and Drug Administration Medical Device Registration Division or Medical Device Supervision Department staff.

Overseas inspection workload, high professional requirements, faced with many unexpected situations, therefore, the inspectors is a big challenge.

Zhao Guangyu, a national equipment inspector who first participated in the overseas production site inspection in 2015, said that overseas inspection needs to declare the plan ahead of time and send an invitation letter to other enterprises according to the requirements of foreign affairs. So it has not yet achieved random and non-informative overseas inspection, which to a certain extent, restricted the effectiveness and scale of the inspection.

Li Xintian, who led the on-site inspection in Japan, claimed that due to differences in language, cognition, culture and customs, various unexpected situations may still occur on the inspection site even though the preparations and plans have been fully carried out in advance. , Commissioned the production, quality management system related functions broken down to a number of related or unrelated companies.

'Inspectors are constantly tested abroad and their ability to handle communication,' said Li Xintian.

In October 2017, the Office of the State Council and the State Council issued the Circular on Deepening the Reform and Approval of the Examination and Approval System for Reviews drug medical instruments Innovation Opinions "(hereinafter referred to as" Opinions "), the medical device regulatory authority to make the general requirements.

It is understood that the State Food and Drug Administration in light of the actual situation, in-depth investigation and study based on the scientific design of the medical device regulatory authority to determine the system of division of power, adhere to all levels of supervision to assign the task of supervision and inspection, supervision and inspection around the guidance, focusing on strengthening Overseas production enterprise Site inspection to ensure that inspection tasks are not exhausted.

In order to standardize the overseas inspection of medical and medical equipment, the State Food and Drug Administration released the Provisions on the Administration of Overseas Medical Equipment Inspection (Draft for Comment) in December 2017, the general rules for the overseas inspection of medical and medical equipment, the determination of inspection tasks Process, inspection process, audit and handling processes and principles, and related by-laws, attachments have made it clear.

Wang Aijun said that the increase of overseas production site inspection of medical equipment, on the one hand you can urge foreign manufacturers to comply with China's medical equipment manufacturing quality management practices and other related Regulations , But also exercise our country's medical device inspectors of the international inspection capabilities and international level.

However, according to the new regulatory authority for medical devices, the face of more than 4,000 overseas enterprises and hundreds of domestic production and management companies each year's flight inspection tasks, rely on the existing part-time inspectors is far from enough to support.

It is learned that the next step, the State Food and Drug Administration Medical Device Supervision Division will speed up the implementation of "opinions" requirements, issued guidance to promote the establishment of national and provincial level full-time inspectors team to train inspectors with a high level of international inspection capabilities , Strive for the early realization of the import of high-risk medical device products full coverage inspection objectives.