Analysis and expert interpretation of the latest progress in the special approval of innovative medical devices in China

Foreword:

Issued on February 7, 2014, and implemented on March 1, 2014The "Special Approval Procedure for Innovative Medical Devices (Trial Implementation)" stipulates a special approval channel for medical devices with Chinese invention patents, technically possessing a domestic first-creation and internationally leading level, and with significant clinical application value.Since the implementation of the "Special Approval Procedure for Innovative Medical Devices (Trial Implementation)", China has accelerated the market launch of innovative medical devices with high technological content and urgent clinical needs, while also accelerating the pace of import substitution of high-end medical devices.

Current Status of Innovative Medical Device Approval

《Special Approval Procedure for Innovative Medical Devices (Trial Implementation)》（Revised in 2017 to "Special Review Procedure for Innovative Medical Devices")Since its implementation, as of the first quarter of this year, China has225 products that have entered the special review channel for innovative medical devices, of which57 innovative medical devices have been marketed through the special review procedure.These products are mostly domestically created, internationally original, or represent significant technological advancements, filling gaps in relevant fields. Among them, in the first quarter of this year,15 products were included in the special review procedure for innovative medical devices, and 3 products were approved for marketing.

From the perspective of product approval,From 2014 to the first quarter of this year, the number of products launched annually through the special review procedure for innovative medical devices has shown a continuous upward trend. The time it takes for innovative products to go from research and development to market launch has been further shortened.According to statistics, the review and approval time for innovative medical device products is shorter on average than that of other ordinary Class III products for the first registration by83 days.。

Leading Provinces (Cities) in the Industry

From the perspective of the geographical distribution of product approvals,the four major industrial provinces (cities) of Beijing, Shanghai, Guangdong, and Jiangsu are in the first echelon in terms of the number of innovative medical devices included in the special approval (excluding imported products), with Beijing having46, ranking first, Shanghai with 38, Guangdong with 36, and Jiangsu with 31. In addition, Beijing also ranks first in the number of approved products, with 19, followed by Shanghai with 11, Guangdong with 10, and Jiangsu with 8.

The following are some of the reasons for Beijing's leading position in accelerating the launch of innovative medical devices:

First,. Beijing's drug regulatory authorities have provided advance guidance and standardization of the quality system for start-up companies' products, significantly shortening the time required for quality system verification from the original30 days to 6 days;

Second,. in the product testing phase, the Beijing Medical Device Testing Institute gives priority service to all innovative medical device products, shortening the testing period for some large medical devices with high technological content from nearly3 months to one and a half months. The average testing period for all innovative products is shortened by more than 1/3;

Third,. Beijing's drug regulatory authorities have also opened a green channel for the approval of Class II innovative medical devices within their scope of responsibility, shortening the total approval time from170 days to an average of 22 days.

Distribution of Innovative Medical Device Types

In terms of product type, the approved innovative medical devices are mainly/implantation and interventional medical devices, with high-value consumables accounting for the highest proportion, especially vascular stents in vascular interventional products.

Currently,4 vascular stents have been marketed through the special review procedure for innovative medical devices. These are the branched aortic covered stent and delivery system from Shanghai MicroPort Medical (Group) Co., Ltd., the abdominal aortic covered stent system from Beijing Humantech Medical Device Co., Ltd., the bioabsorbable coronary drug-eluting stent system from Lepu (Beijing) Medical Device Co., Ltd., and the abdominal aortic covered stent and delivery system from Shanghai MicroPort Med-Tech Co., Ltd. In 2017, the bioabsorbable coronary drug-eluting stent systems from Shanghai Baixin’an Biotechnology Co., Ltd., Beijing Amate Medical Device Co., Ltd., Shenzhen Sinopharm Bio-Medical Engineering Co., Ltd., and Shanghai Maiquan Medical Device Co., Ltd. were also included in the special review procedure. This means that China's vascular stent industry is already at the forefront of the global market and is expected to be among the first to achieve import substitution among various high-end medical devices.

In addition, pioneering blockbuster products in the fields of in-vitro diagnostics and medical imaging are also continuously being approved.

Xiamen Aid Biopharmaceutical Technology Co., Ltd.'s"Human 10 Gene Mutation Combined Detection Kit (Reversible Termination Sequencing Method)" (Weihui Jian) is the first cross-cancer NGS (next-generation sequencing) companion diagnostic product, covering the genes that need to be detected for all currently marketed targeted drugs for lung cancer and colorectal cancer.

Shanghai United Imaging Healthcare Co., Ltd. independently developed China's first integrated positron emission tomography and magnetic resonance imaging system, which was approved for marketing and officially installed and used at Huashan Hospital Affiliated to Fudan University, filling a gap in the domestic field.

Applicant Approval Status

Amongmore than 180 companies, Shanghai MicroPort Medical and its subsidiaries have a relatively large number of products included in the special approval for innovative medical devices, with a total of 15 products, 5 of which have been approved for marketing, including 2 electrophysiological products, 2 covered stents, and 1 vascular reconstruction device.

Xien Technology (Shenzhen) Co., Ltd. has8 products included in the special approval, among which the left atrial appendage closure system and implantable cardiac pacemaker were approved for marketing in June and December 2017 respectively, establishing a clear advantage in the domestic closure device and cardiac pacemaker field. Beijing Pinchi Medical Equipment Co., Ltd. has 2 sets of neural stimulation electrode kits approved, Shanghai United Imaging has 2 of its 4 applied innovative medical imaging products approved, the 2 nucleic acid detection products of BGI Group Co., Ltd. were all approved, and the 2 gene detection kits of Aid Bio were also approved.

Summary

The number and time of innovative medical device certifications and approvals reflect the role of China's innovative medical device approval policies in accelerating the market launch of innovative medical devices. From the perspective of industry regulation, regulatory authorities in various regions can refer to and learn from the experiences of Beijing and Shanghai in accelerating review and approval to enhance local medical device innovation and product launches.

In 2018, the National Medical Products Administration (NMPA) issued more than 50 announcements, notices, and policy interpretation documents.The content covered multiple aspects, including medical device catalog revisions, registration and approval, clinical trials, post-market surveillance, and production and operation.，同时，多项法规政策在Meanwhile, multiple regulations and policies were officially implemented in 2018.

In an environment of rapid regulatory updates, stricter law enforcement, and heavier penalties, domestic and foreign medical device manufacturers, upstream suppliers, and the entire medical system face a series of challenges and opportunities. How to quickly respond to regulatory updates, improve product launch efficiency, and accelerate R&D and market transformation has become an important issue for enterprises.The "Special Review Procedure for Innovative Medical Devices," as one of the updated regulations, can effectively help enterprises achieve higher efficiency in medical device research and innovation and promote the application of new medical device technologies, thereby driving the development of the medical device industry.