GB9706 series standards status update has been released by the National Institutes for Food and Drug Control (NIFDC) on January 19, 2024. As of January 8, 2024, a total of 1885 certificates have been issued for 75 GB 9706 new standards. Additionally, there are 103 institutions certified for the GB 9706.1-2020 qualification and 125 institutions certified for the YY9706.102-2021 qualification.
In this article, we provide a comprehensive overview of the frequently asked questions received by various provincial MPAs to address the commonly seen issues impacting the implementation of GB 9706 standards.
Question 1: What are the basic requirements for registrants and filers under the GB9706 standards?
As outlined in the “Notice of the National Medical Products Administration on the Implementation of GB 9706.1-2020 and Supporting Parallel Standards and Special Standards” (No. 14 of 2023, hereinafter referred to as the 14th Notice), medical device registrants and filers must diligently implement the requirements of the “Standardization Law of the People’s Republic of China,” the “Regulations for the Supervision and Administration of Medical Devices,” the “Measures for the Administration of the Registration and Filing of Medical Devices,” and the “Measures for the Supervision and Administration of the Production of Medical Devices.” This ensures that the products they produce comply with mandatory standards and technical requirements either through registration or filing. Registrants and filers are encouraged to proactively implement the new standards.
Question 2: How do I determine the date for implementing the new standards for my product?
According to the 14th Notice and its interpretation:
- For products covered by specific standards associated with GB 9706.1-2020, the implementation date of the new standards is determined based on whether the specific standard is mandatory or recommended.
- If the specific standard is mandatory, compliance is necessary
- If the specific standard is recommended, companies may choose to comply or not. However, if decided to comply with the associated parallel standard, synchronization with GB 9706.1-2020 and its associated parallel standards shall be carried out upon the publication of this specific standard.
- For products without specific standards associated with GB 9706.1-2020, the new standards and parallel standards have been implemented from May 1, 2023, onwards.
Question 3: What are the considerations when implementing the new standards for registration and filing?
- For initial registration/filing: Compliance with the new standards is required for products applying for registration or filing after the implementation date specified in the 14th Notice.
- For registration renewal:
- Application timing: Renewal applications should be submitted at least 6 months before the expiration date.
- Evaluation requirements: Renewal applications submitted before the implementation date specified in the 14th Notice will be evaluated according to the original standards, while those submitted after will be evaluated according to the new standards.
- Documentation requirements: Submission documents should adhere to the requirements outlined in the relevant regulations.
- Non-renewal circ*mstances: Non-renewal may occur if deadlines are missed, if products cannot meet new mandatory standards, or if conditions specified in the registration certificate are not fulfilled.
- Recommendation: Timely renewal applications are advised based on product registration validity, applicability of new standards, and progress of inspection work.
Question 4: Is registration modification mandatory after the implementation of GB 9706.1 on May 1, 2023?
Yes, according to Article 39 of the “Measures for the Supervision and Administration of the Production of Medical Devices,” registrants and filers must identify differences between product technical requirements and mandatory standards promptly. If modification is necessary, relevant procedures should be completed accordingly.
Question 5: Which medical devices are subject to the GB9706 series standards?
Medical devices subject to the GB9706 series standards include a wide range of equipment across various medical fields. The GB9706.1 standard primarily focuses on general safety requirements for medical electrical equipment, covering protection against electrical, mechanical, radiation, and overheating hazards, along with extensive risk management content in the new version. Additionally, specific standards within the series apply to equipment with certain functionalities or intended uses, such as radiation protection, alarms, household applications, emergency aid, and physiological closed-loop controllers.
Question 6: Are there online training resources available for the GB9706 series standards?
To facilitate understanding and ensure uniformity in implementing GB9706.1-2020, the National Medical Products Administration’s Standards Management Center has produced of explanatory videos for 59 published standards in the 9706 series. These videos, created in collaboration with relevant technical committees and key editors, are freely accessible on the Center’s official website. Additionally, the Center plans to continue releasing similar training videos for newly published 9706-related standards.
For further information and access to training videos, please visit: National Medical Products Administration’s Standards Management Center Official Website.
This Q&A aims to provide clarity on the implementation of new medical device standards and the necessary procedures for compliance. Should you have any further inquiries or require assistance, please do not hesitate to contact us.
Further information
Read our article on GB9706.1-2020 that came into effect on May 1, 2023.
Read our article clarifying implementation of GB9706.1-2020.
Read the previous article GB9706.1-2020 implementation explained by NMPA.
Discover our services for medical device registration, renewals and NMPA Legal Agent.
