China GB9706 Medical Electrical Equipment Standards Expert Consultation Mechanism is launched

China GB9706 Medical Electrical Equipment Standards Expert Consultation Mechanism was launched by the National Medical Products Administration (NMPA) on August 29, 2023.

The GB9706 Expert Consultation Mechanism has been introduced to study and solve major technical problems in the implementation of the GB 9706.1-2020 standard and its supporting parallel or special standards in a timely manner.

Background:

GB 9706.1-2020 “Medical Electrical Equipment Part 1: General requirements for basic safety and basic performance standard” and its supporting parallel standards came into effect on May 1, 2023.

It is the basic standard for China medical electrical equipment and this new series introduced 76 changes, which have far-reaching and much-increased levels of standards meaning the industry needs to commit to high-quality development.

The GB 9706.1-2020 standard and its supporting parallel standards, such as the Puliu Standard and Yikuanchuan Standard, play a crucial role in the regulation of medical devices and electrical medical equipment in China.

Significant technical challenges have been encountered during the execution of GB9706.1-2020 and its associated parallel and special standards. These challenges often involve discrepancies in the interpretation of standards among regulatory bodies, technical review departments, and medical device inspection institutions.

To address major technical issues impacting the implementation of these standards, an expert consultation mechanism has been established. This mechanism aims to facilitate collaboration, resolve differences in understanding, and promote standardized implementation, ultimately ensuring the successful adoption of these standards.

Member Units of the China GB9706 Medical Electrical Equipment Standards Expert Consultation Group:

The leading unit responsible for managing this mechanism is China’s National Institute for Food and Drug Control (NIFDC), specifically its Center for Medical Device Standards Management (CMDE).

Other member units include the NMPA’s Center for Medical Device Evaluation and relevant standards' Technical Sub-Committees for Standardization of Medical Devices.

Local Medical Products Administration (MPA) departments, technical review departments, and medical device inspection institutions involved in standards consultations can also participate based on the standards in question.

GB9706 Expert Consultation Working Procedures:

Provincial MPA departments, technical review departments, and medical device inspection departments facing major technical challenges can submit written consultations to the Center for Medical Device Standards Management.
The Center for Medical Device Standards Management organizes the Technical Committee for Medical Device Standards to research the matter under consultation. The committee communicates with the proposing unit and provides opinions within 15 working days. If consensus is not reached, an expert consultation may be initiated.
Expert consultation involves meetings where expert consultation group member units recommend which experts should be involved. The Center for Medical Device Standards Management presides over the meeting, reaching consensus or conducting voting if needed.
For issues affecting the full implementation of standards, explanatory documents are drafted based on expert consultation. National standards are submitted to the Department of Standardization Administration under the State Council, while industry standards are issued by the NMPA.

Please note that this announcement is for information purposes only. Medical device and medical equipment manufacturers cannot request an Expert Consultation on the interpretation of GB9706 and its parallel or special standards.