In the first half of 2021, the newly revised "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the "Regulations") were formally implemented, the regulatory system for medical device supervision was accelerated, two medical device evaluation and inspection sub-centers started operation, and the medical device industry was innovated and developed The environment continued to be optimized, and 13 innovative medical devices were approved for listing. At the same time, the safety management of medical devices is advancing steadily. The investigation and management of hidden risks of medical devices has been launched simultaneously nationwide. The first batch of medical device unique identifications have been fully implemented, and the second batch of medical device supervision scientific research projects have been officially released... All levels of drug regulatory authorities have implemented in-depth implementation Implement the "four strictest" requirements, adhere to the bottom line to ensure safety, chase the high line to promote development, and promote the important phased results of the medical device supervision work, effectively guaranteeing the safety of the public's use of equipment.
01. Continuously strengthen the ability to service epidemic prevention and control
In the first half of this year, the State Food and Drug Administration completed the approval of 8 new coronavirus testing reagents and 3 new coronavirus pneumonia epidemic prevention and control related equipment approvals. As of mid-July, the maximum production capacity of new coronavirus detection reagents has reached 45.414 million copies per day.
In order to effectively protect the quality and safety of medical devices, in the first half of this year, a total of 12 unannounced inspections of new crown virus detection reagent manufacturers were completed, and follow-up inspections were carried out in a timely manner to ensure that the rectification of defects found in the inspections was implemented in place. Drug regulatory authorities at all levels have increased their supervision and inspection efforts, mobilizing more than 40,000 inspectors to carry out supervision and inspection of 40 manufacturers of new coronavirus detection reagents; organized and carried out special random inspections of new coronavirus detection reagents, and newly approved new coronaviruses The detection reagents shall be included in the sampling scope in time. In addition, 22 medical equipment manufacturers for epidemic prevention and control have been supervised and inspected, which effectively guarantees the quality and safety of medical equipment for epidemic prevention and control.
02. Implementation of the newly revised "Regulations"
On June 1 this year, the newly revised "Regulations" were formally implemented. The State Food and Drug Administration organized a series of publicity and implementation work.
On March 18, the State Food and Drug Administration issued the "Notice on Studying, Publicizing and Implementing the Regulations on the Supervision and Administration of Medical Devices"; "Learning, publicity and implementation; on April 8, the first online public welfare promotion meeting for the newly revised "Regulations" under the guidance of the State Food and Drug Administration, sponsored by China Health Media Group, and undertaken by China Medical News Agency was held.
At the same time, various local drug regulatory authorities have organized in-depth study of the contents of the newly revised "Regulations" by the leaders and supervisors of medical device companies in various forms. As of July 12, 30 provinces (autonomous regions and municipalities) including Beijing and Zhejiang have carried out publicity and implementation activities for the newly revised "Regulations".
03. Accelerate the formulation and revision of supporting documents of the newly revised "Regulations"
In order to ensure the effective implementation of the newly revised "Regulations", the State Food and Drug Administration has conducted special studies on the formulation and revision of supporting regulatory documents of the "Regulations" and made clear arrangements.
It is understood that two regulations will be issued soon. At present, 14 regulatory documents for solicitation of comments have been drafted and completed, including medical device registration requirements and approval document formats, and the revision of the "Medical Device Clinical Trial Quality Management Specification" has also been organized.
The revision of "Measures for the Supervision and Administration of Medical Device Production" and "Measures for the Supervision and Administration of Medical Device Operation" is being accelerated. In addition, the State Food and Drug Administration has issued the "Catalogue of Class II Medical Devices Exempted from Operation and Recordation" on June 30.
04. The second batch of regulatory scientific research projects was launched
In June of this year, the State Food and Drug Administration initiated the implementation of the second batch of key projects of the China Drug Regulatory Scientific Action Plan, including research on innovative and clinically urgently needed medical device evaluation methods, research on the diagnosis and treatment of emerging infectious diseases, and medical devices. Safety effectiveness and quality control evaluation research and other medical device-related research projects.
05. The Yangtze River Delta and Dawan District Centers started operation
In December 2020, the Yangtze River Delta Sub-center and the Dawan Sub-center of the State Food and Drug Administration's medical device technical review and inspection center were listed. On May 13 this year, the two sub-centers officially started operation.
The two sub-centers resonate at the same frequency as the Medical Device Technology Evaluation Center of the State Food and Drug Administration (hereinafter referred to as the Device Evaluation Center). The internal quality management system of the Apparatus Examination Center is extended to the sub-centers, and more than 90 management systems such as related quality control systems and information traceability systems have been gradually established; the internal circulation process of the Apparatus Examination Center and the sub-centers has been established to achieve one-stop consultation for the sub-centers Service.
The two sub-centers also fully mobilized review resources, arranging instructors for innovative medical device projects, oriented service companies' innovative R&D, and serving the innovative development of the medical device industry in the Yangtze River Delta and the Greater Bay Area. Sub-center inspection quality management system and inspector team building also achieved positive results.
06. Speed up the launch of innovative medical device products
In January this year, the State Food and Drug Administration approved the registration application for the innovative product "Iliac Artery Bifurcation Stent System" produced by Lifetech (Shenzhen) Co., Ltd. This is since the National Food and Drug Administration set up a fast-track approval channel for innovative medical devices in 2014 , The 100th innovative medical device approved for listing.
So far, the State Food and Drug Administration has approved 113 innovative medical devices, and 38 medical devices have been approved for priority. Among them, 13 innovative medical devices were approved for the market in the first half of 2021 alone, including 7 priority products that are urgently needed for clinical use. These innovative medical devices are close to or reach the international advanced level and have significant clinical application value. Some innovative medical devices fill the gaps in related fields in my country and better meet the people's demand for high-quality and high-level medical devices.
07. Promote the investigation and management of hidden risks of medical equipment simultaneously across the country
In March of this year, the State Food and Drug Administration deployed medical device quality and safety risk investigation and management work, sorting out 9 categories of products and companies, including epidemic prevention and control medical devices, and centralized procurement of selected products, as the focus of risk investigation and management.
With the large-scale vaccination of the new coronavirus vaccine across the country, the demand for single-use sterile small-format syringes has increased sharply. The State Food and Drug Administration promptly deployed and carried out relevant investigations and special inspections. At the same time, it is deployed to carry out full coverage inspections for enterprises related to single-use sterile small-size syringes.
In addition, the State Food and Drug Administration has also deployed various localities to continuously carry out the “cleaning network” of medical devices, guiding local governments to strengthen the supervision and inspection of sterile and implantable medical device operators and users. Supervise relevant medical device operating companies, users, and third-party platforms for online transaction services to conduct comprehensive self-examinations, form a ledger for the hidden risks discovered, and implement rectifications one by one.
08. Speed up the implementation of the unique identification of medical devices
Starting from January 1 this year, the first batch of 69 medical device varieties in 9 categories will implement unique identification. In order to expand the application of unique identification, in April this year, the State Food and Drug Administration held a promotion meeting for unique identification to promote the application of unique identification in the fields of medicine, medical care, and medical insurance.
On July 19, the State Food and Drug Administration issued a public comment on the "Announcement on Doing a Good Job in the Implementation of the Second Batch of the Implementation of the Unique Identification of Medical Devices (Draft for Solicitation of Comments)." The remaining third-class medical devices (including in vitro diagnostic reagents) are included in the second batch of implementation of unique identification, and other medical devices are supported and encouraged to implement unique identification.
In the first half of this year, in order to guide the industry to implement unique identification, the State Food and Drug Administration increased training on the basic general standards related to unique identification. Apply for the standard project of "Medical Device Unique Identification and Carrier Representation" and organize the formulation of relevant standards, which stipulate the basic requirements for the creation and assignment of unique identification, and effectively solve the common problems in the implementation of the current unique identification system.
09. Further optimization of the medical device standard system
On March 30, the National Standardization Management Committee of the State Food and Drug Administration issued the "Opinions on Further Promoting the High-Quality Development of Medical Device Standardization", planning and deploying key tasks for medical device standardization.
The State Food and Drug Administration formulated the "Medical Device Compulsory Standards Optimization Work Plan", clarified the compulsory standard evaluation principles, and organized optimization evaluations of 396 currently effective medical device compulsory standards and 62 established mandatory standard revision projects Work, and publicize 77 medical device industry standards annual revision plan projects in 2021 according to procedures.
The construction of the standard system has further promoted the research and development of new biomaterials and the transformation of their achievements in the field of medical devices: On March 15, the State Food and Drug Administration issued the "Guiding Principles for the Naming of Recombinant Collagen Biomaterials" to further standardize the naming of recombinant collagen biomaterials; On March 18, approved two medical device industry standard revision projects, "Recombinant Collagen" and "Tissue Engineering Medical Device Product Collagen Part 3: Collagen Content Detection-Liquid Chromatography-Mass Spectrometry"; April On the 15th, the "Principles for the Classification and Definition of Recombinant Collagen Medical Products" were issued to standardize the management attributes and management category determination of recombinant collagen medical products. On June 28, the recombinant type III humanized collagen freeze-dried fiber was approved for marketing. This product is my country's first self-developed medical device prepared with a new type of biological material-recombinant humanized collagen, which has laid a good foundation for the clinical application and industrial transformation of related materials.
10. Continued strengthening of regulatory capacity building
Inspector capacity building is an important part of supervisory capacity building. In the first half of this year, the State Food and Drug Administration strengthened the training and education of inspectors and held training courses for senior inspectors and continuing education and training, including courses on unannounced inspections for medical device manufacturers, and requirements for the production and quality control of implantable medical devices. In addition, 15 companies in Suzhou, Shanghai and other places have been identified as training bases for medical device inspectors, and continue to promote the construction of inspector training bases.
In terms of reviewer team building, two phases of medical device registration and application training and four phases of medical device registration and review business training were carried out in the first half of this year, covering more than 3,000 people. In addition, an online training platform of "Device Review Cloud Classroom" has been built to provide R&D registrants, supervisors, scientific researchers, etc., with courses such as introduction to review procedures, interpretation of rules and regulations, and explanation of review requirements to meet the needs of all parties in the medical device industry. Individual needs.