Advocacy to alleviate bottlenecks for medical device industry in implementation of GB 9706 standards series

Background

The National Standard GB 9706.1-2020 Medical Electrical Equipment series was revised by the National Medical Products Administration (NMPA) in order to adopt the international standard IEC 60601-1:2012 while taking Chinese characteristics into account. The resulting new Chinese standards have a broader scope and more content requirements, with the fundamental change in the introduction of a new concept of risk management, which poses additional challenges in understanding and implementing the standards.

According to the State Council’s Decree 739, Measures for the Supervision and Administration of Medical Device Manufacturing, which came into effect on 1^st June 2021,“[a]fter a mandatory standard is promulgated, registrants of medical devices should fulfill their obligations of product change registration in a timely manner.”  Under the National Standard GB 9706.1-2020 Medical Electrical Equipment series, 75 standards have been released, 47 of which came into force as of 1^st May 2023. Of those 47 standards, 45 are mandatory. The changes to registration of medical devices mandated by this series of standards require additional type tests. However, taking into account the quantity of medical devices that will need to be re-registered, the number of available qualified testing institutes and their testing capacity are insufficient to allow for the completion of those tests and registration changes prior to the implementation of the new standards. As a result, the supply of medical products and their availabilty to Chinese patients and medical staff would be adversely affected.

Official data reveals that the NMPA received around 4,000 applications for ‘registration changes’ in 2022. However, according to calculations by the European Chamber’s Healthcare Equipment Working Group, the number of registration certificates of Class II and III medical devices involved in the implementation of this series of standards has reached 2,680,000, which is equivalent to the NMPA’s workload for approximately 6.7 years.

Efforts

With its members under pressure due to these registration challenges, the Healthcare Equipment Working Group actively engaged in policy advocacy: joining NMPA symposiums for chambers and associations, submitting advocacy letters prior to and proposing recommendations to the NMPA during the meetings.

Moreover, the working group collaborated with the Medical Products Administrations as well as Standard Management Departments at both national and local levels to conduct thorough research, as well as to urge member companies to have their management, compliance, quality and production departments actively participate in training sessions and industry seminars on the implementation of the new standards. The working group also facilitated enterprises—in  particular small and medium-sized enterprises, including their overseas headquarters—to understand the standards, implementation policies and requirements, and organised study tours to the Medical Device Inspection and Testing Institute in both Beijing and Liaoning Province.

Throughout 2022 and into early 2023, the working group maintained close communication and cooperation with the NMPA to seek solutions together.

Results

On 16^th March 2023, the NMPA published the Implementation Measures for GB9706.1-2020 and its Supporting Standards (Announcement #14/2023). It states that for registered Class III and Class II medical electrical devices, registrants should apply for registration changes promptly, submit inspection reports that meet the requirements of the new standards and complete the product registration changes in accordance with the new standards within a period of three years from the effective date of the relevant standards.

This decision grants a three-year extension for the completion of product registration changes, which alleviates the dilemma encountered by both the industry and regulatory authorities. It provides the industry with sufficient time to complete the implementation of the new standards and avoid compliance risks.