China medical device registration review requirements have been updated by the National Medical Products Administration (NMPA). The review requirements for both medical device registration filing projects and in-vitro diagnostic (IVD) registration filing projects have undergone a comprehensive revision by the NMPA.
Some provisions have been added, some simplified, and others clarified with more detail.
The objective of this review is to further deepen the reform of the review and approval system and encourage the innovation of medical devices, in accordance with the “Administrative Measures for Registration and Filing of Medical Devices” (No. 47 2021) and other measures.
Scope of application
The newly updated registration review requirements affect all application matters such as medical device and IVD registration, licensing changes, and clinical trial approvals.
Registration project review
The Center for Medical Device Evaluation (CMDE) of the NMPA will review the application materials of the corresponding application in accordance with the revised filing review requirements during the acceptance process. They will check the completeness and compliance of the application materials entering the technical review process, and the consistency of the information provided. The application review does not analyze the rationality and adequacy of product safety, effectiveness evaluation, and does not determine the product risk-benefit ratio.
Implementation date
The revised document was released on September 1, 2022, with immediate effect. Notice No. 42 of 2019, which was the trial version, was repealed at the same time: “Notice of the National Medical Products Administration on Issuing Documents such as “Requirements for Registration of Medical Device Product Registration Projects (Trial)” (No. 42 of 2019).
How to prepare for product application review
Applicants can conduct self-inspections based on this document when preparing their registration application materials. The chapter settings are consistent with the electronic declaration and can be used in conjunction with it.
Change to product application review
The requirements for product filing review are more detailed than those of the notice No. 42 of 2019, with some new contents added and some parts being simplified.
Some examples
To illustrate the type of changes that have been introduced please refer to the tables below:
1. Product filing review documents
A comparison of the previous version to the latest version:
| Item | Before the revision | After the revision |
| CH2.4.1 Passive product descriptions are more detailed | Whether the applicable content of the following information of passive products is submitted: description of the working principle of the product, mechanism of action (if applicable), structural composition (including accessories used in conjunction), main raw materials, and features that distinguish it from other similar products; if necessary, provide illustrative descriptions. | Whether the applicable content of the following information for passive medical devices is submitted: Description of working principle, mechanism of action (if applicable), structure and composition, raw materials (material components that come into direct or indirect contact with the user and/or patient; if the device contains biological materials or derivatives, describe the source and raw materials, intended use, the primary mode of action; if the device contains an active pharmaceutical ingredient (API) or drug, describe the name of the drug, intended purpose of use, the primary mode of action, source), delivery status, and method of sterilization (if applicable, describe who performed the sterilization, sterilization method, sterilization validity period), structure diagram and/or product diagram, usage method and diagram (if applicable), and features that distinguish it from other similar products. |
| Added CH1.9 Communication Statement and CH1.12 Product Overview | New requirements added to submit a Communication Statement and a Product Overvew | |
| CH3.5.5 Added artificial intelligence module | Artificial intelligence: Use deep learning and other artificial intelligence technologies to achieve expected functions and uses, and whether to provide algorithm research materials, including basic algorithm information, data collection, algorithm training, and algorithm performance evaluation. | |
| CH3.5.3 Content of electrical system safety research has been simplified | Electrical system safety, mechanical and environmental protection and electromagnetic compatibility: Submitted the relevant product technical requirements for research and preparation instructions. The basis for determining the relevant indicators is clarified. The standard or method adopted, the reason for adopting and the theoretical basis are clarified. Electrical system safety, mechanical and environmental protection, and electromagnetic compatibility studies were submitted. The research data clarify the following information: research methods, research results, and research conclusions. | Electrical System Safety Research: – Whether research materials on electrical safety, mechanical and environmental protection, and electromagnetic compatibility are provided, indicating applicable standards and studies carried out. – Whether the research plan and research report are provided. |
2. Medical device changes
A comparison of newly released “Requirements for Registration and Review of Registration Items for Medical Device Changes-2022” and the previous “Requirements for Registration of Registration Items for Registration of Changes in Medical Device License Matters (Trial)-2019”.
| Item | Before the revision | After the revision |
| CH3.4.2 is more detailed | Whether to provide a registration inspection report or a commissioned inspection report issued by a medical device inspection agency with medical device inspection qualifications for the changed part of product technical requirements. | Entrusted inspection of the whole project: – Whether an inspection report containing all the required inspection items issued by a qualified medical device inspection agency has been submitted, signed and sealed by the registration applicant. – Test report whether the test results meet the technical requirements of the product. Self-inspection of the whole project, self-inspection of some projects and inspection of some commissioned projects: – Whether an inspection report with all required inspection items affixed with the signature of the applicant has been submitted. – Whether the format of the inspection report meets the requirements of “Medical Device Registration Self-inspection report (Template)”. – Whether the test results of the inspection report meet the technical requirements of the product. – Whether to issue a self-assurance statement for the authenticity of the report. Self-inspection of the whole project, self-inspection of some projects + inspection of some commissioned projects: – Whether to issue a statement with the corresponding self-test capability. – Whether to submit Annex 2: Configuration Table of Medical Device Self-inspection Equipment (including Standard/Reference Products) and Annex 3: Medical Device Self-inspection and Inspector Information Form in “Regulations on the Administration of Self-inspection of Medical Device Registration”. Self-inspection of the whole project, self-inspection of some projects + inspection of some commissioned projects: – If the group company or its subsidiaries are authorized by the group company to carry out self-inspection by the corresponding laboratory, an authorization letter shall be submitted. Self-inspection of some items + commissioned inspection of some items: – The registration applicant should summarize the report issued by the trustee, and form a complete self-inspection report in combination with the inspection items (if any) completed by the registration applicant. In addition to indicating the entrusted inspection agency in the remark column, the original entrusted inspection report shall also be attached. – Verify that the inspection report is issued by a medical device inspection agency qualified for medical device inspection. |
| New content about Basic Review | Whether the original registration certificate related to the change is within the validity period. Or although it has expired, the application for renewal of registration has been accepted or the application for renewal of registration has been submitted on time. | |
| CH3.5.2 content has been simplified | Change-related chemical/material characterization: Submitted the relevant product technical requirements for research and preparation instructions. The basis for determining the relevant indicators is clarified. The standard or method adopted, the reason for adopting and the theoretical basis are clarified. Change-related chemical/material characterization studies were submitted. The research data clarifies the following information: research methods, research results, and research conclusions. | Research on chemical properties: – Provide the basis for determining the chemical/material characterization indicators of the change-related product, the design input source and clinical significance, the standard or method used, the reason for the use and the theoretical basis. – The research plan and research report are provided for each research material. |
3. Medical Device Clinical Evaluation Review Form (Trial)
The “Medical Device Clinical Evaluation Review Form (Trial)” released in 2019 contained three aspects:
- review form for the clinical evaluation exemption route,
- review form of the predicate route
- review form of the clinical trial route.
As for the annex released in 2022, the path of clinical exemption is separated from the other two paths, and is divided into:
- “Medical Device Clinical Evaluation Exemption Catalogue Verification Review Form”
- “Medical Device Clinical Evaluation Review Form”.
4. Clinical trial approval
A comparison of the previous and the latest versions of “Requirements for Review of Medical Device Clinical Trial Approval Projects”.
| Item | Before the revision | After the revision |
| General review questions are more detailed | For imported products, the original information and other information are issued by the applicant’s legal representative or the person in charge of the applicant’s signature, signed and stamped with the seal of the organization, and issued by the applicant’s local notary public notarized documents. | – If there are no special instructions for the declaration of materials of imported products, the original materials should be signed and sealed by the registration applicant, and the Chinese materials should be signed and sealed by the agent. The “signature and seal” of the original document means: the signature of the legal representative or person in charge of the registration applicant, or the signature and the seal of the organization; the “signature” of the Chinese document means: the official seal of the agent, or the legal representative, The person in charge signs and affixes the official seal. – The relevant documents, declaration of conformity, instructions and labels provided by the overseas registration applicant in the imported product declaration materials shall be submitted to the notary issued by the notary office where the registration applicant is located. The notarization can be handled through the electronic notarization mode, but an explanatory document on the new notarization mode issued by the overseas registration applicant shall be submitted at the same time. |
| CH1.3 definitions of abbreviations have been added | Whether to define the terms or abbreviations that need clear meanings that appear in the registration application materials according to the actual situation. | |
| CH2.5.1 has been refined | Whether the applicable content of the following information is submitted: Scope of application: It should be clear that the treatment, diagnosis, etc. provided by the product meet the purpose defined in Article 76 of the Regulations on the Supervision and Administration of Medical Devices, and can describe the medical stage to which it applies (such as post-treatment monitoring, rehabilitation, etc.); Target users and the skills/knowledge/training they should have to operate the product; state whether the product is single-use or reusable; state the device intended to be used in combination with it. Whether the applicable content of the following information needs to be submitted: Applicable population: Information on the target patient population (such as adults, children, or neonates), information on patient selection criteria, parameters that need to be monitored during use, and factors to be considered. Clarify the production process of the product, which can be in the form of a flow chart, and explain its process control points. The production and processing technology of the product is clarified, the key technology and special technology are indicated, and its process control points are explained. The use of various processing aids in the production process and the control of impurities (such as residual monomers, small molecule residues, etc.) are clarified. Clarify the production process of the product, which can be in the form of a flow chart, and explain its process control points. | Whether the applicable content of the following information needs to be submitted: Scope of application: It should be clear that the treatment, diagnosis, etc. provided by the product meet the purpose defined in Article 76 of the Regulations on the Supervision and Administration of Medical Devices, and can describe the medical stage to which it applies (such as post-treatment monitoring, rehabilitation, etc.); Target users and the skills/knowledge/training they should have to operate the product; state whether the product is single-use or reusable; state the device intended to be used in combination with it. |
5. Added “requirements for filing and reviewing medical device registration renewal projects” and “requests for filing and reviewing in-vitro diagnostic reagent registration renewal projects”.
6. Review Form for Clinical Evaluation of In Vitro Diagnostic Reagents
The “Review Form for Clinical Evaluation of In Vitro Diagnostic Reagents – 2019” consisted of two parts: the Review Form for Clinical Trials, and the Review Form for Clinical Catalogue Exemption in the newly released requirements for review in 2022 the two parts are renamed:
- “Review Form for Clinical Evaluation of In Vitro Diagnostic Reagents (Non-clinical Trials)”
- “Review Form for Clinical Evaluation of In Vitro Diagnostic Reagents (Clinical Trials)”.
7. IVD product registration review requirements
A comparison of the latest and the previous versions of “In-Vitro Diagnostic Reagent Product Registration Item Registration Requirements”:
| Item | Before the revision | After the revision |
| CH1.11.1 is more detailed | The applicant declares that this product complies with the current national standards and industry standards, and provides a list of compliance with the standards. | Whether the applicant declares that this product complies with the current national standards and industry standards, and provides a list of conforming standards; whether it has submitted a list of products that conform to national standards. Whether the above documents list all applicable current mandatory national, industry standards and national standard products. |
| New sections have been added: CH1.12 Communication Statement, CH2.2 Product Overview, CH2.6 Product Listing History, CH3.3 List of Basic Principles of Safety and Performance, CH3.6.4 Usability Study, CH6A Quality Management System Document | Requirements have been added to submit a Communication Statement, a Product Overview, a History of Product Listing, a List of Basic Principles of Safety and Performance, a Usability Study, and Quality Management System Documentation | |
| CH1.5 Packaging has been added | Whether to list the packaging specifications, main components of the product to be declared, and the identification (such as article number, device unique identification, etc.) and description of each packaging specification in tabular form. | |
| CH5.2 has been simplified | Submitted a sample packaging label for the smallest sales unit. Imported products should also submit labels approved or recognized by overseas government authorities and their Chinese translations. The submitted label contains the content required by Article 13 of the Regulations on the Administration of Instructions and Labels of Medical Devices. | – Submitted label samples for all minimum sales units. – The submitted label contains the content required by Article 13 of the Regulations on the Administration of Instructions and Labels of Medical Devices. |
8. Requirements for filing and reviewing registration items for changes in in-vitro diagnostic reagents
The difference between “Requirements for filing and reviewing registration items for changes in in-vitro diagnostic reagents – 2022” and “Requirements for filing and reviewing registration items for changes in in-vitro diagnostic reagents licensing items (for trial implementation) – 2019”:
| Item | Before the revision | After the revision |
| CH3.5.4 is more details | Submitted study data on measurement accuracy (including precision). | Submitted studies on measurement accuracy (accuracy/correctness and precision). Precision includes repeatability, intermediate precision, and reproducibility. |
| The following sections have been added: CH1.9 Communication CH1.12 Main Document Registration CH3.4.2 Technical Requirements Change Comparison Table and Inspection Status Chapter 6 Management System Documents | ||
| CH1.04 new requirements for the review of innovative medical devices have been added | The application form is complete with all applicable information. The application form has a data check code. | – The application form is complete with all applicable information. And the application form has a data verification code. – When applying for a change of registration according to innovative medical devices, verify whether the products with the original registration certificate are reviewed in accordance with the “Special Review Procedures for Innovative Medical Devices”. |
| CH3.5.5 has been simplified | Studies on analytical sensitivity were submitted. | The research data of blank limit, detection limit and quantification limit. |
Further information
Please refer to the links below for the latest medical device and IVD registration review requirements and forms:
- Requirements for filing and reviewing medical device product registration projects
- Requirements for filing and reviewing medical device change registration items
- Medical Device Exemption from Clinical Evaluation Catalogue Verification Form
- Medical device clinical evaluation file review form
- Requirements for filing and reviewing in-vitro diagnostic reagent product registration projects
- Requirements for filing and reviewing registration items for changes in vitro diagnostic reagents
- Review form for clinical evaluation of in-vitro diagnostic reagents (non-clinical trials)
- Review Form for Clinical Evaluation of In-Vitro Diagnostic Reagents (Clinical Trials)
- Requirements for the examination and approval of medical device clinical trials
- Requirements for filing and reviewing medical device registration renewal projects
- Requirements for filing and reviewing in-vitro diagnostic reagent renewal registration projects
If you would like to know how the changes affect your medical device or IVD registrations, renewals or changes, or for details of our registration and CRO services for pharmaceuticals, medical devices, IVDs, cosmetics, health foods, and industrial or consumer goods, please contact us.
