Ten Highlights of Medical Device Regulation in the First Half of 2021

  • 2021-07-26
In the first half of 2021, the newly revised Regulation on the Supervision and Administration of Medical Devices (hereinafter referred to as the “Regulation”) came into force, the medical device regulatory system was improved, two sub-centers for medical device evaluation started operation, the environment for innovation and development of medical device industry was continuously optimized, and 13 innovative medical devices were approved for marketing; at the same time, medical device safety governance was advanced steadily, medical device risk and hidden danger investigation and governance were launched simultaneously in China, the Unique Device Identification (UDI) was fully implemented for the first batch of medical devices, the second batch of medical device regulatory science research projects was officially released; furthermore, the medical products administration at each level thoroughly implemented the “Four Strictest (strictest standards, regulation, punishment and accountability)” requirements, adhered to the bottom line to ensure safety, pursued the superior line to promote development, promoted the work of medical device regulation to achieve important phased results, and effectively protected the safety of the public in using medical devices.

01. Continuous strengthening of support for COVID-19 prevention and control

The National Medical Products Administration (“NMPA”) approved eight COVID-19 test kits and three pieces of COVID-19 prevention and control equipment in the first half of this year. The maximum capacity of COVID-19 test kits reached 45,414,000 tests/day by mid-July.

To effectively safeguard the quality and safety of medical devices, unannounced inspections of 12 COVID-19 test kit manufacturers were completed in the first half of this year and follow-up inspections were timely conducted to ensure that the defects found in the inspections are rectified in place. The medical products administration at each level increased supervision and administration efforts, where they dispatched cumulatively more than 40,000 inspectors to supervise and inspect 40 COVID-19 test kit manufacturers; organized special sampling inspections of COVID-19 test kits and also timely included the newly approved COVID-19 test kits in the scope of sampling inspections. Furthermore, 22 manufacturers of medical devices for COVID-19 prevention and control were supervised and inspected, which effectively ensured the quality and safety of such medical devices.

02. The newly revised Regulation coming into force

The newly revised Regulation came into force on June 1 this year, for which the NMPA organized a series of publicity work.

The NMPA issued the Notice on Learning, Publicity, and Implementation of the Regulation on the Supervision and Administration of Medical Devices on March 18; the NMPA issued a notice on March 19 that a publicity group would be set up for the newly revised Regulation, so as to strengthen the learning, publicity, and implementation thereof; the first online publicity meeting of the newly revised Regulation guided by the NMPA, organized by China Health Media Group, and co-organized by China Pharmaceutical News was held on April 8.

At the same time, each local medical products administration organized persons in charge of medical device enterprises, supervision and administration personnel, etc. to thoroughly learn the content of the newly revised Regulation. By July 12, 30 provinces (autonomous regions and municipalities) including Beijing and Zhejiang have conducted activities to publicize the newly revised Regulation.

03. Acceleration of formulation and revision of supporting documents of the newly revised Regulation

To ensure the effective implementation of the newly revised Regulation, the NMPA specially researched the formulation and revision of supporting documents of the Regulation and made explicit arrangements.

It is understood that the Administrative Measures for Medical Device Registration and the Administrative Measures for the Registration of In Vitro Diagnostic Reagents will soon be introduced. Currently, the exposure drafts of 14 normative documents including the Medical Device Registration Application Data Requirements and Approval Certificate Formats are completed, and the revision of the Good Clinical Practice for Medical Devices, etc. is organized synchronously.

The revision of the Measures for Supervision and Administration of Medical Device Production and Measures for Supervision and Administration of Medical Device Operation is being accelerated. Furthermore, the NMPA released the Catalog of Class II Medical Device Products Exempt from Business Filing on June 30.

04. Launch of the second batch of regulatory science research projects

In June this year, the NMPA launched the second batch of key projects of the Action Plan for Drug Regulatory Science in China, including research on the evaluation methods of innovative medical devices and medical devices urgently needed in clinical practice, research on the evaluation of diagnostic and therapeutic products for emerging infectious diseases, research on the evaluation of medical device safety, efficacy and quality control, and other medical device research projects.

05. Yangtze River Delta and GBA Sub-centers starting operation

The Yangtze River Delta Sub-center and the Guangdong-Hong Kong-Macao Greater Bay Area (“GBA”) Sub-center for Medical Device Evaluation, NMPA were unveiled in December 2020 and they officially started operation on May 13 this year.

The two sub-centers collaborate with the Center for Medical Device Evaluation, NMPA (hereinafter referred to as the “CMDE”). The internal quality management system of the CMDE extends to the sub-centers where more than 90 management systems including the related quality control system and information traceability system have been gradually established; the internal circulation process between the CMDE and the sub-centers has been established, and one-stop consulting services have been realized in the sub-centers.

The two sub-centers also fully mobilize review resources, staff instructors for innovative medical device projects, directionally serve the innovative R&D of enterprises, and serve the innovative development of the medical device industry in the Yangtze River Delta and the GBA. The sub-centers have already achieved positive results in terms of inspection quality management system and inspector team building.

06. Further acceleration of the marketing of innovative medical device products

The NMPA approved the registration application of the innovative product G-iliac™ iliac artery bifurcation stent graft system produced by Lifetech Scientific (Shenzhen) Co., Ltd. in January this year, making it the 100th innovative medical device approved for marketing since the NMPA set up the fast track for innovative medical devices in 2014.

The NMPA has so far approved 113 innovative medical devices and included 38 medical devices in the priority review. Among them, 13 innovative medical devices were approved for marketing in the first half of 2021 alone, including seven products urgently needed in clinical practice. These innovative medical devices are close to or at the international advanced level, with significant clinical application value, and some innovative medical devices fill the gaps in related fields in China to better meet people’s demand for high-quality, high-level medical devices.

07. Nationwide advancement of medical device risk and hidden danger investigation and governance

In March this year, the NMPA arranged to carry out medical device quality and safety risk and hidden danger investigation and governance and sorted out nine categories of products and enterprises, including medical devices for COVID-19 prevention and control and products selected in the centralized volume-based procurement, as the focus of the risk and hidden danger investigation and governance work.

The demand for sterile small-size syringes for single use increased dramatically with the extensive COVID-19 vaccination in China. The NMPA promptly arranged to conduct relevant research and special inspections and also arranged to conduct inspections fully covering relevant enterprises of sterile small-size syringes for single use.

Furthermore, the NMPA also arranged localities to continue to carry out the “Clean the Web” campaign for medical devices and guided them to strengthen the supervision and inspection of operating enterprises and using entities of sterile and implantable medical devices and supervise the relevant medical device operating enterprises and using entities as well as third-party platforms that provide online transaction services to conduct comprehensive self-inspections and establish a ledger of the risks and hidden dangers identified for rectification in place.

08. Acceleration of UDI implementation

The UDI for the first batch of 69 varieties of medical devices in nine categories has been implemented since January 1 this year. To expand UDI coordination and application, the NMPA held a UDI advancement meeting in April this year to advance UDI coordination and application in medicine, health care, medical insurance, and other areas.

On July 19, the NMPA started to solicit public opinions on the Announcement on the Unique Device Identification for the Second Batch of Medical Devices (Exposure Draft), intending to include other Class III medical devices (including in vitro diagnostic reagents) in the second batch for UDI implementation in addition to the first batch of 69 varieties in nine categories and support and encourage UDI implementation for other medical device varieties.

In the first half of this year, to guide UDI implementation in the industry, the NMPA increased training in UDI-related basic standards; applied for the approval of the standard, Unique Device Identification and Carrier Representation, and organized the formulation of relevant standards, to stipulate the basic requirements for the creation and grant of unique device identifiers and effectively solve the common problems in the current implementation of the UDI system.

09. Further optimization of the medical device standard system

On March 30, the NMPA and the Standardization Administration jointly issued the Opinions on Further Promoting the High-Quality Development of Medical Device Standardization to plan and arrange the key tasks of medical device standardization.

The NMPA also formulated the Work Plan for the Optimization of Mandatory Standards for Medical Devices to define the principles of assessing mandatory standards, organize the optimization and assessment of the formulation and revision projects of 396 medical device mandatory standards currently in force as well as 62 mandatory standards that have been established, and publicize the planned annual formulation and revision projects of 77 medical device industry standards in 2021 according to the procedures.

The development of the standard system further promoted the research and development of new biomaterials and the achievement transformation thereof in the field of medical devices: the NMPA issued the Guidelines for Naming Recombinant Collagen Biomaterials on March 15 to further regulate the naming of recombinant collagen biomaterials; the NMPA approved the establishment of the formulation and revision projects of two medical device industry standards, i.e., Recombinant Collagen, and Tissue Engineering Medical Device Products - Collagen Part 3: Collagen Content Detection by Liquid Chromatography-Mass Spectrometry on March 18; the NMPA issued the Classification Principles of Recombinant Collagen Medical Products on April 15 to regulate the management attributes and management categories of recombinant collagen medical products. The Recombinant Human Collagen Type III Lyophilized Fibers product was approved for marketing on June 28, which is the first medical device prepared with recombinant human collagen, a new biomaterial developed independently by China, laying a good foundation for the clinical application and industrial transformation of related materials.

10. Continuous strengthening of regulatory capacity building

Inspector capability building is an important element of regulatory capacity building. In the first half of this year, the NMPA strengthened inspector training and education and held advanced inspector training courses and continuing education and training, including the specifications for unannounced inspections of medical device manufacturers, production and quality control requirements for implantable medical devices, and other courses. Furthermore, the NMPA also determined 15 enterprises in Suzhou, Shanghai, etc. as medical device inspector training bases to continue to advance inspector training base construction.

In terms of reviewer team building, the NMPA held two sessions of medical device registration application training and four sessions of medical device registration review training in the first half of this year, involving more than 3,000 people. Furthermore, the NMPA also set up the “CMDE Online Class” training platform to provide R&D registration, regulation and research personnel with courses such as review process introduction, rules and regulations interpretation, and review requirements explanation, to meet the individual needs of all parties in the medical device industry.

Source: China Pharmaceutical News