On 8 July 2020, the National Medical Products Administration (NMPA) published, on its official website, the 2019 Annual Report on the Management of Standards for Medical Devices in China. Based on substantial statistics and data, the report provides a comprehensive review of the status of formulation, development and management of China’s standards for medical devices, as well as the establishment of related standardisation organisations, the achievements in international standardisation, and the disclosure of standard information.
In particular, the report shares the following key points and figures:
Medical Device Standards
- Overall developments of 2019
In 2019, 5 new national standards and 72 new sectoral standards were released for medical devices, while amendments were published for 3 existing sectoral standards. This brings the total of medical device standards currently existing in China to 1,671.
At the same time, 99 of the medical device standard formulation and revision projects listed in the 13th Five-year Plan (2016-2020) were completed in 2019 – six of which being national standards, and the remaining being sectoral standards. This brings the total number of 13th Five-year Plan standardisation projects completed to 447 out of 500 (89%).
- Steady growth of standards
During the 10th Five-Year period (2001-2005), the 11th Five-Year period (2006-2010) and the 12th Five-Year period (2011-2015), China respectively formulated 292, 553 and 476 medical device standards. During the four years since the beginning of the 13th Five-year period (2016-2019) and with still one year left, the number of medical devices standards released has already exceeded previous figures: 561. This signals a steady growth of medical device standards in China, driven by the need to establish a medical device standard system that can meet and support the country’s rising demands for medical device regulation and industrial development.
- More reasonable classification of standards
By the end of 2019, among the existing effective medical device standards, there were 273 basic standards, 54 management standards, 406 method standards and 938 product standards.
This is reflected in a significant growth of basic standards and reduction of product standards on the total medical device standards in China, compared to the previous year.
- More comprehensive standard coverage
Medical device standards cover various technical fields of medical devices, including medical electrical equipment, surgical devices, and surgical implants.
According to the Chinese Classification for Standards (CCS), medical device standards mainly fall under the fields represented by codes between C30 and C49. In particular, C30 refers to comprehensive medical device standards, while the other codes mostly refer to specific product fields. The five fields that account for the highest proportion of the existing medical device standards are: C44 medical laboratory equipment (13.8%), C31 general and micro-surgical devices (11.6%), C35 orthopaedic devices (10.8%), C33 dental devices, equipment and materials (9.8%), and C43 medical ray equipment (9.1%).
If sorted according to the fields that different standardisation committees account for, the five fields with the highest number of standards are: medical electrical devices (339 standards, 20%), IVD (243, 15%), surgical implants (209, 13%), dental materials and devices (163, 10%), and infusion devices (148, 9%). Due to different specific requirements, the composition of standards in each management field may vary significantly:
- In the fields of medical electrical equipment and anaesthetic and respiratory devices, basic standards account for a relatively high proportion, both reaching 29%;
- The fields of medical device standard management and quality management have the highest proportion of management standards – 100% and 85.7% respectively;
- The highest proportion of method standards is found in the field of biological evaluation of medical devices, reaching 90.2%;
- The highest proportion of product standards is found in the fields of family planning and IVD devices – 86.2% and 86% respectively.
- Continued efforts to convert mandatory standards into recommended standards
By the end of 2019, there were 395 mandatory standards for medical devices, 85 of which being national standards, and 310 being industry standards. In 2019, in order to follow the State Council’s decision to integrate and streamline mandatory standards, NMPA issued the Notice on the conversion of 40 mandatory sectoral standards for medical devices into recommended sectoral standards. Among the 40 converted standards, which include “Protective devices against diagnostic medical X-radiation — Part 1: Determination of attenuation properties of materials”, 23 (57.5%) are product standards, 9 (22.5%) are basic standards, 7 (17.5%) are method standards, and 1 is management standard.
Management of Medical Device Standards
In 2019, NMPA issued three key documents to further refine the normative requirements of the medical device standard and regulation system:
- Requirements for the Management of Medical Device Standardisation Work Archives (September, https://www.sohu.com/a/340348284_712054);
- Key Points of Medical Device Standard Audit (not available for the public);
- Detailed Rules for Examination and Evaluation of Medical Device Standardisation Technical Committees (not available for the public);
At the same time, NMPA also revised the Detailed Rules for the Verification of Medical Device Standards, and the Workflow for the Audit and Approval of Medical Device Standards. These documents form the formative foundation for China’s medical device standard system.
Establishment of Medical Device Standardisation Organisations
In recent years, China has made great efforts in organising and establishing standardisation committees for various emerging fields. The objective is to promote the development of the medical device standard system, and in particular standardisation activities in emerging technology fields and in medical device areas where China has strong competitiveness, such as AI medical devices and nano medical devices.
In 2019, two sub-TCs were approved and established by SAC, namely:
- Active Implants Subcommittee of the National TC for Surgical Implants and Orthopaedic Devices (SAC/TC 110/SC4);
- Biological Evaluation of Nano Medical Devices Subcommittee of the National TC for the Biological Evaluation of Medical Devices (SAC/TC 248/SC1).
Three management units were approved, responsible for medical electroacoustic equipment, the medical additive manufacturing technology and AI medical devices.
Over 40 years of development since the establishment of the first TC for medical devices in 1980, the number of medical device standardisation committees in China has gradually increased to 32, thus constantly expanding the scope of medical device standardisation work.
International standardisation work
- Constantly growing alignment between Chinese and international standards
According to statistics, by the end of 2019, the total number of international standards (ISO and IEC standards) for medical devices requiring conversion by China accounted to 670. Among these, 28 were new international standards issued in 2019, while 582 had already been converted or were in the process of being converted by China. If we exclude the 28 newly-released standards in 2019, therefore, China’s conversion rate of international medical device standards exceeded 90%.
- Strengthened communication with ANSI
NMPA organised various China-US seminars on medical device standard systems to further grasp the latest trends of medical device standardisation abroad.
Disclosure of Information on Standards
- Increased disclosure of information on standards
The texts of medical device standards are disclosed on the official website of the Medical Device Standard Management Centre of NMPA. According to the annual report, the catalogue of sectoral medical device standards and the texts of mandatory medical device sectoral standards were fully disclosed. Furthermore, in 2019 the texts of the first batch of 636 recommended medical device sectoral standards without adopting international standards were made public, accounting to an 87% disclosure rate.
- Increased disclosure of information on standard formulation and revision
In order to increase the disclosure of information on standard formulation and revision, and to implement the requirements stipulated in the Management Specifications for Medical Device Standards Formulation and Revision, in 2019 NMPA made effort in the following three areas:
- Expansion of the sources of standardisation projects: NMPA opened to the public the application portal for medical device standardisation project proposals (on the official website of its Medical Device Standard Management Centre), encouraging relevant companies, organisations and individuals to submit standardisation project proposals;
- Extensive solicitation of opinions on standards: in line with the requirements of the Administrative Measures for Medical Device Standards, in 2019 NMPA published for public comments a total of 157 medical device standardisation projects and 136 standard drafts;
- Exploration of standard feedback mechanisms and establishment of public communication platforms: the public can consult about medical device standards-related issues, and contribute their opinions and suggestions through the information platform, where specialized personnel are ready to offer timely response.
For the original text of the report, visit: