Medical device registration verification, why difficult to pass

Medical network December 15 hearing with the medical device life cycle management philosophy put forward the standardization of China's medical device industry, regulatory standards continue to improve, scientific supervision and management began to implement and improve one by one.According to statistics, since 2016, nearly 300 The products were withdrawn voluntarily during the registration phase. 'The reasons are mainly the defects or deficiencies in R & D compliance, risk management, clinical authenticity and production practices, etc.' Jiang Haihong, Director of Medical Device Supervision Department of Shanghai Medical College of Health, broke through the phrase.

Recently, the first medical device registration verification points and post-listing regulatory forum held in Kunming. At the meeting, the long-term responsibility for the registration of medical device products in Guangdong Province Food drug Yang Guang, deputy director of the Administrative Licensing Office of the Supervisory Authority, said:

'medical instruments Registration of quality management system verification is the last pass of the product market, determines whether the product can be registered, but also to ensure the real security of listed products, stable and reliable quality management system verification .Quality management system construction should cause our country medical equipment enterprise The height of attention.

The core of the medical device registration quality management system verification (hereinafter referred to as 'registration verification') is to extend the inspection of the overall quality system of the enterprise through the verification of the application and management of product samples, storage management, production management, inspection and management, and departmental responsibilities Establishment and operation of the enterprise so as to judge whether the quality management system established by the enterprise can effectively analyze and control the product risk and then draw the conclusion that the enterprise applies for the product sample.

'From a practical point of view, the one-time pass rate of registration of medical device companies' products is almost zero, even though enterprises like Shenzhen Mindray fail to pass them one time. "Yang Guang sighed.

According to reports, in 2016 Guangdong Provincial Bureau completed more than 700 types of second-class device registration verification, coupled with the State Food and Drug Administration commissioned the completion of 170 third-class registration of equipment in the country, completed a total of more than 870 products listed on the market Verification work, of which, once completely denied 10%, the rest of the basic have to go through 'rectification and re-examination' in order to pass the inspection.

Shanghai Food and Drug Administration, Lin Feng, director of registration of medical devices also said that the majority of Shanghai medical device registration verification most of the need for 'review after rectification', after review in line with << Medical Device Manufacturing Quality Management Code >> and related appendix requirements of all relevant items in order to Grant registration.

The last few "did not pass the verification", the technical examination and approval department made a review of the registration is not registered.Product registration can not be a one-time pass, need to review the rectification of the enterprise should be a one-time within six months to submit to the original verification department to review the application and Rectification report.This will not only waste regulatory resources, but also delay the product time to market.

'2014 revised "Medical Device Supervision and Management Ordinance," after the implementation of the original device quality management system assessment replaced by the registration quality management system verification, higher requirements.' Yang introduced, based on the registration verification is pre-market medical device quality management system Verification of the last pass, shoulder the solemn responsibility of the authenticity of on-site verification, so registration verification for the successful registration of medical devices has a veto power.

'Even if the other registration information, the registration test done no matter how good.' Yang stressed that after a vote was vetoed, companies need to re-apply for registration, wasting valuable time and registration fees, especially the time to market, because all the processes To re-queue.

There are more than 200 provisions in the 4 guiding principles of "Good Manufacturing Practices for Medical Device Production" and related appendices. If any one of the key items with "*" sign does not meet the requirements, it will fail to pass the examination. Other non-critical items The project allows 3 to 5 does not meet the requirements, but the review suggested that the conclusion of 'rectification and re-examination'. 'This means no small pressure on the business,' Yang said.

According to the Beijing Fuller Technology vice president and manager of the representative of Qiu Wanyu introduced, the company received an annual average of 2 new product registration verification. 'In the "medical device manufacturing quality management guidelines for medical device implant site inspection guidelines," the orthopedic There are nearly 300 items of material requirements, of which 46 are key items, each one must be treated with caution.

One does not pass, the declaration of registration was abandoned. "He said that any minor problems in the quality management system, even non-critical items, must be rectified as required, after review of qualified before allowing registration, it is bound to be on the market Time has an impact.

According to Guangdong's experience in the registration and verification of medical device products in recent years, it can be found that most enterprises are prone to problems in the following aspects:

First, the terms of understanding there are deviations, such as not pay attention to the production address information, environmental monitoring report approved, the technical requirements did not leave the factory testing and type testing;

Second, the declaration of information problems, such as declaration of product development and manufacturing address is not clear, the declaration of the product has not yet completed the design and development, do not have the appropriate production conditions, the hardware there are serious shortcomings;

Third, irregular verification items were found during on-site verification. For example, quality management system can not meet product risk management, lack of effective control over design and development, and lack of substantive R & D activities.

Quality management, to be "systematic" work hard

Yang Guang said: 'In order to meet the strict regulatory requirements, medical device companies must extend the management chain, especially SMEs, if we are struggling to meet the ever-increasing technical and business threshold, the importance of quality management system is easy to recognize, Neglecting the management of the system problems, it means there are hidden dangers of quality, companies must pay attention to this.

'If it is to correct the hardware project, rectification and construction of the longer time required; if you encounter key project defects, registration verification can not be passed; if it is the preparation of documents, on-site operation and other soft terms, the correction is relatively easy. Correct scientific management concepts, training outstanding full-time manager representatives, good quality management system is the only cure. "Yang Guangru said.

Beijing Food and Drug Administration on November 14 issued a "medical device manufacturers in Beijing on behalf of the management system (Trial)", requiring that from January 1, 2018 onwards, the Beijing Municipal Medical Device Manufacturing Executive Executive Representative System.Determine the definition of manager representative refers to the medical device manufacturers in the corresponding professional background or technical qualifications, and the corresponding work experience, authorized by the person in charge of production enterprises, overall responsibility for the effective operation of quality management system managers, Previously, Guangdong and Shanghai issued regulatory guidelines for managers of medical device manufacturers in 2010 and 2015, respectively.

Many start-ups focus only on the production technology itself, while ignoring the establishment of a quality management system and the lack of professional quality management staff. "Li Yong, manager representative of Shanghai Minimally Invasive Medical Devices (Group) Co., Ltd., It is very necessary for a medical device manufacturer to set up a full-time manager's representative. Professionals should do professional work.

Management representatives can make good records of the system support documents, to participate in product development, clinical, production, until after the listing Adverse reactions Monitoring, tracking follow-up, product recall and other life cycle management.

Yang reminded, medical device manufacturers should strengthen management representatives Regulations , Normative documents learning and understanding; regulators should also strengthen the supervision and verification personnel and business communication, promote each other to improve the verification efficiency, speed up the approval of medical devices listed.