Guangdong Provincial Drug Administration promotes high-quality development of medical device industry

In 2018, Guangdong Province's medical device output value was approximately 160 billion yuan, with a compound annual growth rate exceeding 20%; as of September this year, Guangdong Province had 3191 medical device manufacturing enterprises, and in Shenzhen alone, there were 53 companies with an output value exceeding 100 million yuan in 2018. These data showcase the booming development of Guangdong's medical device industry.

Recently, reporters conducted in-depth investigations into Guangdong Province's drug regulatory departments and medical device enterprises, deeply experiencing the warmth and intensity of Guangdong's medical device supervision, as well as the speed and height of the industry's development.

Releasing Dividends: Pilot Implementation of the Registrant System

In the exhibition hall of Guangzhou MaiPu Regenerative Medical Technology Co., Ltd., reporters saw a craniomaxillofacial repair system made of polyetheretherketone. Compared to traditional titanium mesh, this new material offers better biocompatibility and more perfect shaping.

“The implementation of the medical device registrant system pilot program has provided MaiPu with a new direction, helping us achieve our goals of centralized production and optimized production capacity.” Deng Kunxue, director of the R&D department of Guangzhou MaiPu Regenerative Medical Technology Co., Ltd., introduced that the craniomaxillofacial repair system was originally produced by its wholly-owned subsidiary, Shenzhen MaiPu Regenerative Medical Technology Co., Ltd. To reduce production costs and achieve centralized production, MaiPu started preparing to reregister the product at its headquarters in Guangzhou in December 2017. After Guangdong Province implemented the medical device registrant system pilot program in August 2018, Shenzhen MaiPu immediately applied to entrust Guangzhou MaiPu with the production of the craniomaxillofacial repair system, and obtained the first national Class III medical device registration certificate under the pilot program in October of this year.

It is understood that in the more than one year since the pilot program of the medical device registrant system in Guangdong Province, companies such as Shenzhen MaiPu, Shenzhen Libang, and Shenzhen Yangzijing have applied to be registrants through the method of internal group entrusted production, achieving optimized resource allocation.

Recently, the Guangdong Provincial Drug Administration also piloted changes to internal medical device registrants. That is, for enterprises that meet the conditions for inclusion in the Guangdong Province medical device registrant system pilot program, where elements related to product quality have not changed, the quality system and product technical documents have been effectively transferred, and the subject of product quality responsibility is clear, changes to the registration matters are processed.

Encouraging Innovation: Accelerated Progress in Import Substitution

Domestic high-end medical devices are constantly emerging, especially those capable of import substitution, which has positive significance for meeting clinical needs. Guan Zhiyong, general manager of the central R&D management department of Shenzhen Mindray Bio-Medical Electronics Co., Ltd., said that in the field of monitoring equipment, domestic equipment accounts for more than 60% of the market share.

Taking Mindray Medical as an example, through global layout and increased R&D innovation efforts, it has achieved good results in replacing imported products. Data from Great Wall Securities shows that in 2018, Mindray Medical's market share in the domestic monitoring equipment market was 64.8%, ranking first; its market share in anesthesia equipment was 16%, ranking third; and its market share in operating room equipment (lights and beds) was 11%, ranking second. Mindray Medical's products cover nearly 110,000 medical institutions in China and more than 99% of Class-A hospitals.

Zhu Liming, chairman of Shenzhen Anke High-Tech Co., Ltd., believes that the rapid rise of domestic medical devices in Shenzhen is closely related to the support of drug regulatory departments at all levels. The implementation of electronic filing of medical device registrations by the national drug regulatory authorities, opening up special approval channels for innovative medical devices, etc., has played an important role in shortening product launch cycles for enterprises and seizing market opportunities. The Guangdong Provincial Drug Administration has also continuously promoted various regulatory measures, standardizing market competition order, and promoting compliant operation, intensive training, and steady development of enterprises.

Innovative Supervision: Accelerated “Delegation, Regulation, and Service” Reform

As of now, Guangdong enterprises have 39 innovative products that have entered the national special review process for innovative medical devices, accounting for approximately 20% of the national total; 7 have entered the priority review process of the National Medical Products Administration, accounting for approximately 36% of the national total… A vibrant innovation industry cannot be separated from the impetus of scientific supervision.

“The current average administrative approval time is only one-third of the statutory time limit.” Fang Wei, director of the Administrative Licensing Office of the Guangdong Provincial Drug Administration, introduced that the Guangdong Provincial Drug Administration actively implemented the requirements of the “delegation, regulation, and service” reform, innovated its supervision approach, adjusted its internal organizational structure and optimized processes, implemented one-stop approval, implemented list-based and standardized management of all matters, and accelerated the overall administrative approval process by 72%; it promoted the associated review system for some medical device matters, implementing “one-window acceptance, combined inspection, parallel approval, and simultaneous licensing”; it explored the informed consent system for approval, with most businesses speeding up to completion within 1 working day, with the fastest approval speed reaching 95%.

In addition, the Guangdong Provincial Drug Administration actively promoted reforms to the review and approval system, giving priority to the approval of registration applications for some clinically urgently needed products, key research and development products, and medical devices with innovative technologies. The time limit for registration testing and technical review was reduced by more than 40% compared to the statutory requirements, and the administrative approval time limit was reduced by more than 50% compared to the statutory requirements.

To strengthen the full-chain supervision of medical devices, the Guangdong Provincial Drug Administration also actively carried out a “cleanup” operation for medical devices; it increased the intensity of flying inspections, listing the production of sterile and implantable medical devices as a priority for flying inspections, resolutely safeguarding the bottom line of quality and safety.

Relevant officials from the Guangdong Provincial Drug Administration stated that a strong industry requires a strong regulatory foundation, and the bureau will continue to promote the Guangdong medical device industry to become a shining name card for the domestic medical device industry.