The application rate is 14.7%.

Innovation is an important driving force for economic growth under the new normal, and it is also a strategic deployment of the CPC Central Committee and the State Council on Several Issues on Deepening the Reform of Institutional Mechanisms and Accelerating the Implementation of Innovation-Driven Development Strategies. In order to encourage the innovation and development of the medical device industry, in March 2014, the State Food and Drug Administration issued the “Special Approval Process for Innovative Medical Devices (Trial)” (hereinafter referred to as the “Special Approval Procedure”). Then, how many applications have entered or passed the review of the special approval process, how can the relevant departments ensure that the approval process is scientific, rigorous and fair? Over the past year or so, these issues have received a lot of attention from the society. The reporter recently learned from the Medical Device Technology Evaluation Center of the State Administration of Taxation (hereinafter referred to as the “Review Center”) that as of April this year, the review center received 196 applications for special approval for innovative medical devices, and completed the review of 156 applications. Among them, 23 applications were approved, and the overall adoption rate was 14.7%; 6 registration applications have entered the technical review process, and the evaluation center has given priority review, and 3 of them have been concluded.

Develop a standardized joint review

The reporter learned from the evaluation center that after the publication of the Special Approval Procedure, the Evaluation Center established the Innovative Medical Device Examination Office according to its requirements. The review office is led by a deputy director of the evaluation center. The members include the head of the registration department of the Medical Device Registration Management Department of the State Administration of Taxation, the head of the evaluation center, the head of the China Biomedical Engineering Society, and the head of the secretariat. Collective research and decision-making on expert review opinions and related issues in the form of member work meetings to ensure the scientific and fair review work.

The Evaluation Center drafted the “Regulations on the Examination and Approval of the Application for Special Approval of Innovative Medical Devices (Trial)”, established the work system confirmed by the expert review and review office, and selected the principles of experts, the procedures for determining the experts, the procedures for reviewing the procedures, and the procedures for determining the opinions. The aspect formed a clear working system and formulated scientific and rigorous work norms for the review.

According to reports, in the selection of review experts, the evaluation center commissioned relevant societies to recommend review experts in accordance with the prescribed conditions, and the classmates will eventually select the most authoritative experts and scholars in the relevant research fields to participate in the review. The expert review will implement the team leader responsibility system.

At the same time, the Evaluation Center also formulated the “Innovative Medical Device Communication and Technical Review Operational Practices (Trial)”, which clarified the duties, procedures and exit conditions of innovative medical device communication and technical review into the special approval process. It provides a legal basis for the realization of innovative medical device communication and priority review within the protection center.

In addition, for the case problems in the actual operation process and the weak links in the review process and mechanism, the review office will convene a member work meeting in a timely manner, study the handling of related matters, collectively form a handling opinion, and strengthen the acceptance with the State Administration by holding a working symposium. Communication and coordination between the Center and local provincial bureaus for innovative medical device review.

The three types of equipment apply the most

The relevant person in charge of the evaluation center told the reporter that as of the 196 applications received in April this year, 4 applications for imported innovative medical devices were applied, and the applications for innovative medical devices in China involved 17 provinces and cities, and the three provinces and cities with relatively more applications applied separately. It is Beijing, Jiangsu, and Guangdong. In terms of product categories, there are 188 applications for management of medical devices in the third category, accounting for 96%; in terms of product types, the proportions from high to low are passive implantable products, in vitro diagnostic reagents, and active Products, passive non-implantable products, accounted for 35.6%, 30.9%, 22.3%, 11.2%.

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