The National Medical Products Administration ("NMPA") issued the Circular on the Work Relating to the Implementation of GB 9706.1-2020 and Supporting Concurrent Standards and Special Standards (No. 14 of 2023, hereinafter referred to as the "Circular") on 16 March 2023. NMPA also released two interpretation documents relating to the Circular respectively on 16 March 2023 ("NMPA Interpretation I") and 7 April 2023 ("NMPA Interpretation II").
The national standard GB 9706.1-2020 (the General Requirements for Medical Electrical Equipment Part 1: Basic Safety and Basic Performance, "GB 9706.1-2020") was published on 9 April 2020, and all of its supporting concurrent standards have been published, while special standards are being released gradually (the aforementioned supporting concurrent standards and special standards are referred to as "Relevant Standards"). As of February 2023, 69 standards under the new GB 9706 series have been published, 67 of which are mandatory standards and 2 (usability and closed-loop controllers) are recommended standards.
The Circular specifies the obligations of medical device registrants and filing entities in implementing the GB 9706.1-2020 standard, along with the obligations of technical review, inspection, supervision and administration entities, and the below will focus on the former.
1. Strict Implementation of Relevant Standards
Section 1 of the Circular emphasizes that medical device registrants and filing entities shall ensure that the relevant products they produce comply with mandatory standards and the technical requirements of registered or filed products. Medical device registrants and filing entities are encouraged to implement Relevant Standards before their coming into effectiveness.
The Circular provides a schedule listing the effectiveness date for GB 9706.1-2020 and all the Relevant Standards (including "Supporting Concurrent Standards" and "Special Standards"). GB 9706.1-2020, as a general national standard, came into effectiveness on 1 May 2023. Each Supporting Concurrent Standard and each Special Standard have different implementation time.
Regarding the implementation time between GB 9706.1-2020, Supporting Concurrent Standards and Special Standards, according to the NMPA Interpretation I the rules are as below:
| Scenarios | Implementation Rules |
| If a medical device product is subject to a Special Standard that applies under GB 9706.1-2020 and such Special Standard has been publicized |
GB 9706.1-2020 and the relevant Supporting Concurrent Standards can be implemented simultaneously with the last Special Standard appliable to the product. - For example, the last Special Standard that will be implemented and which is applicable to pulse oximetry equipment is YY 9706.261-2023 "Medical Electrical Equipment Part 2-61: Basic Safety and Basic Performance Special Requirements for Pulse Oximetry Equipment". Then for such products, GB 9706.1-2020 and the relevant Supporting Concurrent Standards can be implemented in parallel with YY 9706.261-2023 on 15 January 2026. |
| If a product is subject to a Special Standard that applies under GB 9706.1-2020 and such Special Standard has not been publicized |
GB 9706.1-2020 and the relevant Supporting Concurrent Standards can be implemented simultaneously with the Special Standard when such Special Standard comes into force. - For example, YY 9706.278 "Medical electrical equipment Part 2-78: Basic Safety and Basic Performance Special Requirements for Rehabilitation, Assessment, Compensation or Relief Medical Robots" is under stipulation and has not yet been published. Then, for these products, GB 9706.1-2020 and relevant Supporting Concurrent Standards can be implemented at the same time as the specified implementation date of YY 9706.278 when it is released. |
| If there is no applicable Special Standard to a medical device product | GB 9706.1-2020 and relevant Supporting Concurrent Standards shall be implemented from 1 May 2023. |
2. Implementation Requirements Relating to Registration and Filing
According to Section 2 of the Circular and NMPA Interpretation I, implementation requirements applying to different scenarios are as below:
| No. | Scenario | Implementation Requirements |
| 1 |
- There is Special Standard applicable to the product and the publicized implementation time for such Special Standard is before 31 December 2025; or - There is no appliable Special Standard |
For those products that already have obtained registration certificate or have completed filing before the implementation of such standards: - there is three-year extension period for completing change of registration to carry out the new standards for registered medical products and two-year extension period for filed medical products. For instance, if the applicable Special Standards will be implemented as of 1 May 2024, then the change of registration of the already registered medical products shall be completed before 1 May 2027. - if there is no appliable Special Standard, or if the appliable Special Standard is implemented on 1 May 2023, the change of registration shall be completed before 1 May 2026 while change of filing shall be completed before 1 May 2025. |
| For those products that will apply for registration or filing for the first time after the implementation of the relevant standards, then the inspection report that conforms with the new standards shall be submitted and the products cannot be released to the market after obtaining the registration certificate or completing filing. | ||
| 2 | There is Special Standard applicable to the product and the publicized implementation time for such Special Standard is on or after 31 December 20251 |
For those products that already have obtained registration certificate or have completed filing before the implementation of such standards: - There is no extension period. The change of registration or filing for implementation of the new standards shall be completed before the implementation date of the new standards. For instance, if the applicable Special Standard will be implemented on 15 January 2026, then the medical products registrants that have already obtained registration certificate shall complete change of registration before 15 January 2026 while the medical products registrants that have completed filing shall complete change of filing before 15 January 2026. |
| For those products that have already filed application for registration or filing before the implementation of the standards, they can be inspected according to the original standards and the examination and approval can be done according to the original standards. | ||
| For those products that will apply for registration or filing for the first time after the implementation of the relevant standards, then the inspection report that conforms with the new standards shall be submitted and the products cannot be released to the market after obtaining the registration certificate or completing filing. |
According to Section III of the Circular, the inspection report can be issued by the registration applicant itself or by qualified medical device inspection institutions.
3. Implementation Requirements Relating to Renewal
NMPA Interpretation II provides the rules for renewal of medical device registration or filing in relation to the change of standards due to the implementation of GB 9706.1-2020 and Relevant Standards.
According to Article 82 and Article 83 of the Administrative Measures for the Registration and Record-filing of Medical Devices (effective as of 1 October 2021), the registration applicant shall apply for renewal of registration of medical devices six months before the expiry of the validity period. If there are compulsory medical devices standards that have been modified and the products applying for renewal cannot meet the new standards, the renewal will not be granted.
Moreover, according to the Circular of the National Medical Products Administration on Relevant Matters Concerning the Implementation of the Administrative Measures for the Registration and Record-filing of Medical Devices and the Administrative Measures for the Registration and Record-filing of In Vitro Diagnostic Reagents (effective as of 28 September 2021), for medical devices applying for registration and if the mandatory standards cited in the technical requirements of the products have changed, unless otherwise specified by the National Medical Products Administration in the document on the issuance and implementation of standards, the registration accepted before the date of implementation of the new standards can be reviewed and approved in accordance with the original standards. From the date of implementation of the new standards, enterprises shall fully implement the new standards and the products shall meet the requirements of the new standards.
Therefore, according to Section 1 of Interpretation II,
- for renewal applications made before the implementation date of GB 9706.1-2020 and Relevant Standards, the examination and approval can be made according to the original standards;
- for those renewal applications made on or after the implementation date of GB 9706.1-2020 and Relevant Standards, then the examination and approval shall be made in accordance with GB 9706.1-2020 and Relevant Standards.
4. Implementation Requirements for Recommended Standards
According to NMPA Interpretation II, it is intended to encourage medical devices enterprises to implement recommended standards. Some Special Standards are recommended standards, for instance Special Standard GB/T 9706.266. If a medical device enterprise chooses to implement GB/T 9706.266, then GB 9706.1-2020 and its Supporting Concurrent Standards can be implemented along with GB/T 9706.266 after it is publicized. If a medical device enterprise chooses not to implement GB/T 9706.266, then GB 9706.1-2020 and its Supporting Concurrent Standards shall be implemented as of 1 May 2023.
5. Label
In accordance with Article 16 and Article 17 of the Administrative Provisions on Instructions and Labels of Medical Devices (effective as of 1 October 2014), in the event of any change in registration of a registered medical device, the applicant shall, after obtaining the change document, modify the instructions for use and label according to the change by itself. In case of any change of any content recorded in the record-filing information form, the filing entity shall modify the instructions for use and label according to the change by itself.
6. Supervision and Administration
The Circular requires that, for medical device products registration applicants or filing entities that have followed the GB 9706.1-2020 with Relevant Standards and have already completed change of registration or filing, local NMPA shall require the registration applicants or filing entities to organize production in strict compliance with the mandatory standards and technical requirements of the product.
If the medical device products registration applicants or filing entities have not followed the GB 9706.1-2020 with Relevant Standards and have not completed the change of registration or filing after the implementation date of the new standards, the registration applicants or filing entities shall make commitment to complete the change of registration or filing and local NMPA shall strengthen supervision on such entities.
7. Comments
We advise that medical device companies should first check the applicable Relevant Standards that will apply to their products and determine the application date of the GB 9706.1-2020 with Relevant Standards applicable to their products. Then, medical devices companies shall take effective measures to implement GB 9706.1-2020 and Relevant Standards. For those products that have already obtained registration or completed filing according to the applicable standards back then before the coming into effectiveness of the GB 9706.1-2020, special attention needs to be paid as to before when such products shall complete the change of registration or filing content pursuant to new standards. For those products that are in the process of renewal or will apply for renewal, they need to follow the rules laid down in the Circular and NMPA interpretations as specified above.
Footnote
1. The Interpretation does not specify the applying requirement for those standards that will be implemented on 31 December 2025. For prudence, we have included those standards that will be implemented on 31 December 2025 into the category where a stricter requirement applies.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
