The second interpretation of the “Notice on the Implementation of GB 9706.1-2020 and its supporting parallel standards and special standards”

1. For products registered before the date of implementation of GB 9706.1-2020 and supporting parallel standards and special standards (hereinafter referred to as the new version of GB 9706 series standards), how to continue the registration?

The “Notice on the Implementation of GB 9706.1-2020 and Supporting Collateral Standards and Special Standards” (No. 14 of 2023, hereinafter referred to as Circular No. 14) does not specifically stipulate special regulations for renewal registration, and renewal registration shall comply with relevant laws and regulations and normative document requirements.

According to Article 22 of the “Regulations on the Supervision and Administration of Medical Devices” and Articles 82 and 83 of the “Measures for the Administration of Medical Device Registration and Filing”, the validity period of the medical device registration certificate is 5 years. If it is necessary to renew the registration upon expiration of the validity period, an application for renewal of registration shall be submitted to the original registration department 6 months before the expiration of the validity period. Under any of the following circumstances, the renewal registration will not be granted: (1) The registration renewal application is not submitted within the prescribed time limit; (2) The mandatory standards for medical devices have been revised, and the medical devices applying for renewal registration cannot meet the new requirements; (3) For medical devices approved with conditions, the matters stated in the medical device registration certificate have not been completed within the prescribed time limit. Therefore, after the release and implementation of the new mandatory standards for medical devices, if the medical devices applying for registration renewal cannot meet the requirements of the new standards, the registration renewal will not be granted.

The “Notice of the State Drug Administration on the Implementation of the “Measures for the Administration of Registration and Filing of Medical Devices” and the “Measures for the Administration of Registration and Filing of In vitro Diagnostic Reagents” (No. 76, 2021) clearly states: “For medical devices applying for registration, other If the mandatory standards quoted in the product technical requirements change, unless otherwise stipulated by the State Food and Drug Administration in the release of the implementation standard documents, if the registration is accepted before the date of implementation of the new standards, the review and approval can be carried out according to the original standards. From the date of implementation of the standard, enterprises should fully implement the new standard, and products should meet the requirements of the new standard.”

Paragraph 2 (1) of Circular No. 14 clearly requires the implementation of the new version of GB 9706 series standards for product registration and filing: “If the product is applicable to the supporting special standards of GB 9706.1-2020, GB 9706.1-2020 and the supporting parallel standards can be combined with the last implemented special standards. Standards are implemented at the same time. If there is no supporting special standard for GB 9706.1-2020, GB 9706.1-2020 and supporting parallel standards will be implemented on May 1, 2023.” Therefore, the new version stipulated in the second (1) of the Circular No. 14 Those who apply for registration renewal before the implementation date of the GB 9706 series standards can be reviewed and approved according to the requirements of the original standards; those who apply for registration renewal after the implementation date of the new version of the GB 9706 series standards stipulated in the second (1) of the Circular No. 14 should follow the new version of GB The 9706 series of standards require review and approval. For example, for products without applicable special standards, the registration renewal application applied before May 1, 2023 can be reviewed and approved according to the requirements of the original standards; those applied after May 1, 2023 should be reviewed and approved according to the requirements of the new version of GB 9706 series standards. Review and approval. For products with applicable special standards, if the implementation date stipulated in the announcement of the special standards is May 1, 2024, the registration renewal application applied before May 1, 2024 can be reviewed and approved according to the requirements of the original standards; in 2024 Applications starting from May 1 shall be reviewed and approved according to the requirements of the new GB 9706 series of standards. The application materials for renewal registration shall meet the requirements of Annex 6 “Requirements and instructions for application materials for renewal registration of medical devices” in the “Announcement on Publishing the Requirements for Application Materials for Medical Device Registration and the Format of Approval Documents” (No. 121, 2021).

It is recommended that the registrant apply for renewal of registration in due course according to the validity period of the product registration certificate and the expected completion of the inspection work.

2. For those special standards that are recommended standards, how to implement the new version of GB 9706 series standards in the product registration and filing work?

The special standard GB/T 9706.266 “Medical Electrical Equipment Part 2-66: Special Requirements for Basic Safety and Basic Performance of Hearing Devices and Hearing Device Systems” is a recommended standard and has not yet been released. In order to encourage the implementation of recommended standards, for the registration of products applicable to GB/T 9706.266, GB 9706.1-2020 and supporting parallel standards can be determined by the choice of the enterprise: if the enterprise chooses to implement GB/T 9706.266, then GB 9706.1-2020 and supporting standards The parallel standard can be implemented together with GB/T 9706.266 after the release of GB/T 9706.266; if the enterprise chooses not to implement GB/T 9706.266, then GB 9706.1-2020 and supporting parallel standards should be implemented from May 1, 2023. For example, for hearing aids, if the enterprise chooses not to implement GB/T 9706.266, the first application for registration from May 1, 2023 shall submit an inspection report that complies with GB 9706.1-2020 and supporting parallel standards; For the registration certificate, the modification registration shall be completed in accordance with the requirements of GB 9706.1-2020 and supporting parallel standards before May 1, 2026; the renewal registration application applied before May 1, 2023 may be reviewed and approved according to the requirements of the original standards; May 2023 Applications starting from January 1st shall be reviewed and approved according to the requirements of GB 9706.1-2020 and supporting parallel standards.

 3. For the implementation date of special standards after December 31, 2025, how to implement the new version of GB 9706 series standards for product registration and filing?

For special standards with an implementation date stipulated in the announcement of relevant standards after December 31, 2025, products that apply for registration for the first time or undergo filing for the first time from the date of implementation of the relevant standards specified in paragraph 2 (1) of Circular No. 14, An inspection report that meets the requirements of the new GB 9706 series of standards should be submitted. Those who apply for registration before this and are accepted, can be inspected, reviewed and approved according to the original standards. For example, for pulse oximeters, the last applicable standard is YY 9706.261-2023 “Medical Electrical Equipment Part 2-61: Special Requirements for Basic Safety and Basic Performance of Pulse Oximeter Equipment” (January 15, 2026 implementation date), therefore, starting from January 15, 2026, those who apply for registration for the first time should submit an inspection report that complies with the new version of GB 9706 series standards. Encourage medical device registrants and filers to implement the new version of GB 9706 series standards in advance.

 4. For registered products, how to change product instructions and labels?

According to Articles 16 and 17 of the “Regulations on the Administration of Medical Device Instructions and Labels” (the former State Food and Drug Administration Order No. 6), “the contents of the medical device instructions that have been registered and reviewed by the food and drug administration shall Changes. In the event of a change in the registration of a registered medical device, the applicant shall, after obtaining the change document, modify the instructions and labels by itself according to the change document.” If other contents of the instruction manual change, the filer shall amend the relevant contents of the instruction manual and label by himself.” After the product has completed the change registration or change filing of the new version of GB 9706 series standards, the product instruction manual and label may be modified.