1. How should the continuation registration be carried out for products that were registered prior to the implementation of GB 9706.1-2020 and comply with parallel standards and special standards (hereinafter referred to as the new GB 9706 series standards)?
Notice regarding the Work related to the Implementation of GB 9706.1-2020 and its Supporting Parallel and Special Standards (No.14 in 2023, hereinafter referred to as No.14 Notice), does not contain any specific provisions for registration continuation; therefore, it is required that such continuation must comply with relevant laws, regulations, and normative documents.
According to Article 22 of the "Regulations on Supervision and Administration of Medical Devices" and Articles 82 and 83 of the "Measures for Registration and Filing Management of Medical Devices", a medical device registration certificate is valid for five years. If renewal is required after expiration, an application for renewal must be submitted to the original registration department six months prior to expiration. The registration shall not be renewed under any of the following circumstances: (1) the application for renewal of registration is not filed within the prescribed time limit; (2) The mandatory standards for medical devices have been revised, and the medical devices that apply for renewal of registration cannot meet the new requirements; (3) For medical devices approved with conditions, matters specified in the registration certificate of medical devices have not been completed within the prescribed time limit. Therefore, after the introduction and implementation of new mandatory standards for medical devices, any device seeking renewal of registration must meet these updated requirements. Failure to do so will result in denial of registration renewal.
Notice of the State Medical Products Administration on Matters Related to the Implementation of the Measures for the Registration and Filing of Medical Devices and the Measures for the Registration and Filing of In Vitro Diagnostic Reagents (No. 76, 2021) clearly states: "For medical devices seeking registration, if the mandatory standards referenced in the product technical requirements have been updated, and unless otherwise specified by the State Drug Administration in their implementation guidelines, such devices may be registered prior to the implementation of new standards and evaluated and approved based on original standards. From the date of implementation of the new standard, the enterprise shall fully implement the new standard, and the product shall meet the requirements of the new standard ". No. 14 circular second (a) of the implementation of the new version of the GB 9706 series of standards for product registration and record clear requirements: "Products applicable to GB 9706.1-2020 supporting special standards, GB 9706.1-2020 and supporting parallel standards can be synchronized with the implementation of the final special standards. Products do not apply to GB 9706.1-2020 supporting special standards, GB 9706.1-2020 and supporting parallel standards since May 1, 2023 implementation." Therefore, the application for renewal of registration before the implementation date of the new GB 9706 series standards stipulated in the second (I) of Circular No. 14 can be reviewed and approved according to the requirements of the original standard; Those who apply for the extension of registration after the implementation date of the new GB 9706 series standards stipulated in the second (I) paragraph of Circular 14 shall review and approve according to the requirements of the new GB 9706 series standards. For example, for products without applicable special standards, the application for renewal of registration before May 1, 2023 can be reviewed and approved according to the requirements of the original standard; Those applying from May 1, 2023 shall be reviewed and approved according to the requirements of the new GB 9706 series standards. For products with applicable special standards, such as the implementation date stipulated in the announcement of special standards is May 1, 2024, then the application for renewal of registration applied before May 1, 2024, can be reviewed, and approved according to the original standard requirements; For applications from May 1, 2024, they shall be reviewed and approved according to the requirements of the new GB 9706 series standards. The application materials for extension registration shall meet the requirements of Annex 6 "Requirements and Instructions for Extension Registration Application Materials for Medical Devices" in the Announcement on the Publication of Application Materials for Medical Devices Registration and Format of Approval Documents (No. 121, 2021).
It is recommended that the registrant promptly apply for an extension of registration in accordance with the validity period of the product registration certificate and anticipated completion date of inspection work.
2. For the recommended standard is a special standard, how can we incorporate the new GB 9706 series standard into our product registration and record-keeping processes?
Special standard GB/T 9706.266 "Medical electrical equipment Part 2-66: Special requirements for the basic safety and basic performance of hearing equipment and hearing equipment system" for the recommended standard, has not been released. In order to encourage the implementation of recommended standards, for the application of GB/T 9706.266 product registration work, GB 9706.1-2020 and supporting standards can be selected by the enterprise: If the enterprise chooses to implement GB/T 9706.266, GB 9706.1-2020 and the supporting parallel standard can be released after GB/T 9706.266, and GB/T 9706.266 together with the implementation; If the enterprise chooses not to implement GB/T 9706.266, then GB 9706.1-2020 and the accompanying parallel standard should be implemented from May 1, 2023. For example, hearing AIDS, such as enterprises choose not to implement GB/T 9706.266, since May 1, 2023, the first application for registration, should submit in line with GB 9706.1-2020 and matching standards of the test report; The registration certificate has been obtained before May 1, 2023, should be in May 1, 2026 in accordance with GB 9706.1-2020 and matching standard requirements to complete the change registration; The application for renewal of registration applied before May 1, 2023, can be reviewed and approved according to the original standard requirements; Those applying from May 1, 2023 shall be reviewed and approved in accordance with GB 9706.1-2020 and the corresponding 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 record?
For the special standards after the implementation date of the relevant standards issued by the announcement on December 31, 2025, in the 14th circular second (1) paragraph provisions of the relevant standards from the date of implementation, the first application for registration or for the first time for the record of products, shall submit in line with the requirements of the new GB 9706 series of standards of the inspection report. Those who have applied for registration and obtained acceptance before this date may conduct inspection, review, and approval according to the original standards. For example, for pulse oximeter, the last applicable special standard is YY 9706.261-2023 Medical Electrical Equipment Part 2-61: Special Requirements for Basic safety and Basic Performance of pulse oximetry equipment (implemented on January 15, 2026), therefore, since January 15, 2026, the first application for registration, shall submit the inspection report in line with the new GB 9706 series standards. Registrants of medical devices are encouraged to implement the new version of GB 9706 series standards in advance.
4. For registered products, how can the product specifications and labels be changed?
According to Article 16 and 17 of the Provisions on the Administration of Medical Device Specifications and Labels (former Order No. 6 of the State Food and Drug Administration), "the contents of the medical device specifications registered and examined by the food and drug Administration shall not be changed without authorization. In case of registration change of registered medical device, the applicant shall, after obtaining the change document, modify the description and label by himself according to the change document ", "in case of changes in the contents of the registered medical device, recorded information form, recorded product technical requirements and other contents of the description, the record holder shall modify the relevant contents of the description and label by himself". The product specification and label can be modified after the completion of the new version of GB 9706 series standard change registration or change filing.
Content source: State Medical Products Administration
