Medical network - on July 24, July 19, 37 central comprehensively deepen reform leading group meeting examined and approved the "about deepening the review for examination and approval system reform to encourage drug the opinions of the medical equipment innovation". The conference pointed out that the quality of medical devices and the development of innovation is an important guarantee for building a healthy China. To reform and perfect the evaluation system of examination and approval, the vitality of the medicine industry innovation development, the reform of clinical trial management, speed up the review of examination and approval, promote the quality of generic drugs and curative effect evaluation consistency, improve the food and drug regulatory system, to promote enterprise to improve innovation and research and development ability, to speed up the new good medicine market, meet the clinical need.
Notable is, since 2015 the state council issued by the drug review of medical equipment examination and approval system on the reform of opinion ", since the state food and drug supervision bureau in order to enhance the review for examination and approval, with emphasis on the quality, efficiency and comprehensive deployment review for examination and approval system reform work of medical equipment. We will open new channels for the review of innovative medical devices, release the catalogue of medical devices for clinical trials, focus on reform of technical reviews, and conduct clinical trial supervision and sampling. With the implementation of a series of measures, the reform of the examination and approval system for medical devices in China has achieved periodic results.
Opening up special channels to stimulate innovation and vitality
In 2014, the administration released the innovation medical instrument special approval procedures, on the premise of ensuring the product safety and effective, to conform to the product core technology invention patents and other relevant conditions of innovative medical devices, in the standard under the premise of not reduce, the program does not reduce, set up special examination and approval. In the end of 2016, we issued a guide for the preparation of special examination and approval of innovative medical devices, unified and standardized review work, and improved the efficiency of examination and approval of innovative medical devices. Released at the same time the medical equipment examination and approval procedures for priority clear for diagnosis or treatment of rare diseases, malignant tumor, aged and multiple disease, dedicated to children and urgent clinical needs by medical apparatus and instruments, as well as listed in the national science and technology major projects or the national key research and development plan for examination and approval of medical devices shall be preferred, and released in February the medical apparatus and instruments prior approval notification data writing guide.
In March 2014 to the end of 2016, received the innovation of medical equipment special request for approval of 488 items, complete the review 461, 89 products access to special approval, approval of 20 innovative product on the market. Among them, the pulmonary artery flap pipe filled the gap in the field of the high-end artificial heart valve of domestic medical devices. From January 1 to July 3 this year, nine innovative products were registered and three products were approved for priority approval.
The optimization procedure improves the efficiency of review and approval
The release of the catalogue of clinical trial medical devices will help to reduce the amount of work reported by enterprises. In 2016, the second batch of medical devices exempted from clinical trials were released, and 359 medical device products were exempted from clinical trials. In may, the administration asked for comment on a third catalogue of medical devices exempted from clinical trials.
6 April this year, the administration issued the "about adjusting part of the medical equipment the decision of the administrative examination and approval procedures for examination and approval matters", will be the third type of high-risk medical devices clinical trials for examination and approval decision, domestic class iii medical devices and medical equipment import license change decision, domestic class iii medical devices and imported medical equipment continued to register for examination and approval decision, adjustment for administration of medical devices technical evaluation center (hereinafter referred to as the "administration trial center").
We will vigorously promote the reform of classified management
Classification management is an important basis for reviewing and approving medical devices. In 2016, the general administration combed and analyzed the registered products of more than 60,000 medical devices to form a catalogue of medical devices. The newly revised catalogue framework is more reasonable, more hierarchical, more comprehensive in product coverage, and more scientific and instructive.
In march this year, the general administration announced the list of members of the first medical device classification technology committee, which is a landmark event in the regulatory process of medical devices. The classification technology committee, as an important technical support for the classified management of medical devices in the general administration, has 16 professional teams and has hired 288 members. In April this year, the general administration promulgated the work rules of the medical device classification technical committee of the state administration of food and drug administration, and further strengthened and standardized the work management of the classification technology committee.
The reporter understands that the general administration is organizing the classified technical committee of the technical committee to review and improve the newly revised catalogue of medical devices, which will be released as soon as possible.
Reshape the medical device standard system
To meet the needs of the medical device regulatory and industry development, adapting to new demand of medical devices standards development, administration organization in 2016 to carry out the measures for the management of medical instrument standard revision work. In the same year, there were 250 medical device industry standards, including 48 mandatory criteria, 202 recommended standards, and 1 standard revision list. Streamlined organization to carry out compulsory medical devices standards, and abolish 21 item, into 64, integration, paragraphs 67 and revised 100, retention, 317, mandatory industry standards to 10 mandatory national standards. As of December 2016, China has 1515 medical device standards, including 222 national standards and 1,293 industry standards. Compulsory standard 483, recommended standard 1032.
In April this year, the measures for the administration of medical devices standards, further refinement of the standard management responsibilities and work procedures and revising, has been clear about the product technical requirements and the relationship between the compulsory standards and voluntary standards, strengthen the standard implementation and tracking. In the first half of this year, the general administration organized the revision of 86 medical device standards, which improved the consistency of relevant standards and international standards. At present, the standard of medical devices in China covers the fields of medical devices, the standard system is constantly optimized, and the technical support for the supervision of medical devices is constantly strengthened.
Improve the quality efficiency of technical review
In the past two years, the model of innovation and evaluation of the general administration organ has expanded the scope of "three points" (classification, separation and segmentation) on a pilot basis. Implementation of the project team review, all innovative medical devices for examination and approval of special projects, medical apparatus and instruments for examination and approval of emergency projects, key projects, difficult product registration application projects and clinical trials for examination and approval of projects included in the project team review. In 2016, a total of 880 review projects adopted the panel review model. At the same time, to simplify the application requirements for the continuation of the registration application, the application of the continuation of registration application separately, the unified continuation of the registration of the review requirements. We will further improve the quality management system and system documents of the review and appraisal, release the implementation of the quality management regulations for registration of medical devices, and improve the quality of the review report. Improve the communication system, standardize expert consultation and improve the efficiency of evaluation. Strengthen the team building of the evaluation team, break the establishment restriction, recruit the review staff, strengthen the training of the examinator and continue education, improve the salary treatment, and constantly strengthen the team of the examinators.
In march this year, the administration device whose center, issued the measures for the administration of medical devices technical evaluation expert advisory committee, consultant responsibilities, rights, obligations and management requirements, give full play to the consultant's support, we will improve the mechanism of technical decisions. In April, the general administration of the general administration of China issued the "quality management of medical device technology review" (trial), which aims to standardize the evaluation and improve the quality of reviews.
Strengthen the management of clinical trial source
In 2016, the first "bright sword" in the clinical trial supervision of medical devices in the general administration has caused a strong response in the industry. The general administration has selected 20 registered applications from about 1,500 registered applications and inspected 40 clinical trial organizations. Administration under the state council in conjunction with the relevant ShengJu questioning authenticity problems in eight enterprises of the project, to related project will not be registered, within one year from the date of shall not be registered shall not be again to accept the decision, for alleged false clinical test report issued by the clinical test units and those responsible, instruct relevant ShengJu in accordance with the relevant provisions of the regulations on the supervision and administration of medical devices to investigate. From June 2016 to the end of 2016, 122 companies voluntarily withdrew 263 medical device registration applications.
On July 21, the administration issued notice, clear this year for the first batch of medical instrument clinical trial supervision and spot check project, involving microwave therapy apparatus (1600084) accepted number: CQZ, etc. 10 registration project. The general administration will conduct on-site supervision and inspection of the authenticity and compliance of the clinical trial data of these projects. Clinical trial supervision and spot check for strengthening the legal consciousness of the applicant and the clinical test units, the good faith consciousness, responsibility consciousness and quality consciousness, strong standard medical instrument clinical trial process, hit the fraud behavior, has played a powerful deterrent.
"If there were no medical devices, the achievements of modern medicine would not have been so brilliant; if there were no medical devices, many lives would have been lost." As medical experts have described, medical devices are indispensable for ensuring the health of the people. And constantly promote the reform of system of medical apparatus and instruments for examination and approval of the review, and to inspire the industry development and regulation innovation vitality, in ensuring that the people use the accessibility of medical apparatus and instruments, the role of the security is increasingly apparent. |
