CMDA Amended Regulations on Filings
The first document issued by the CMDE covers certain aspects related to the review of submissions filed by medical device manufacturers in the course of applying for the initial registration of a medical device. In particular, the CMDE intends to make all related procedures more structured and standardized. The authority states that all application materials filed by medical device manufacturers applying for the registration should be subject to review and examination in accordance with the detailed pre-defined requirements that regulate each step of the process. The improvement that the CMDE is going to implement is expected to make the whole application process more efficient, providing that the materials submitted by medical device manufacturers meet the appropriate quality requirements.
In order to implement the principles described hereabove, the CMDE is going to introduce the following rules:
- If data provided in the submission is incomplete or requires correction, a one-time additional payment would be required. If a one-time payment is needed for all materials to be corrected, the authority will inform the medical device manufacturer or its authorized representative (the applicant) accordingly. If the applicant fails to fulfill the request for correction issued by the authority, and the documents submitted still do not meet applicable requirements, an additional correction would be required.
- After receiving the correction request, the applicant shall revise the submission materials in accordance with the recommendations of the authority, perform the self-examination, and submit the set of application documents one more time. The CMDE also mentions that the new submission should be performed strictly in accordance with requirements related to the initial submission. At the same time, it is also important to include all necessary references to the initial submission, otherwise, the CMDE would deem the submission as an entirely new application, and not a correction to the one filed previously.
- When reviewing the submission, the authority will provide the applicant with preliminary opinions, as well as with suggestions related to possible ways to improve the submitted documents. The CMDE will also provide the applicant with additional comments and reminders, when necessary.
Chinese Requirements for the Medical Device Submissions Review
The CMDE states that initial requirements for submission filed in the course of applying for the registration of a medical device in China have been implemented by the appropriate regulation earlier in 2019 by the Circular No. 42. In accordance with the aforementioned regulation, the Center for Medical Device Evaluation will review and examine the submissions from the points of completeness, compliance with the requirements, and consistency of the application materials related to the technical aspects. During this particular stage, the CMDE would neither analyze the rationality and sufficiency of the safety and effectiveness information provided by the applicant nor analyze the benefit-risk ratio of the medical device in question.
During the course of the filing review, the authority only assesses compliance with formal requirements that the documents submitted by the manufacturer should meet. If the submitted materials are not sufficient for the authority to make a final conclusion, the whole process should be suspended and the CMDE shall require the applicant to make all necessary corrections.
The main regulation on the medical device submission review process also contains a list of questions considered by the CMDE when assessing the application filed by the medical device manufacturer. Such questions include:
- Whether the classification code indicated by the manufacturer is correct and matches the nature of the medical device in question.
- Whether both non-clinical and clinical related key aspects are properly explained by the manufacturer, and whether the alternative assessment methods used by the manufacturer, if the product is considered innovative, are properly justified.
- Whether the documents are provided in Chinese or accompanied by the translation.
- Whether the documents provided by the foreign medical device manufacturer are properly signed by the authorized person.
- Whether the content is consistent in all application materials.
Requirements for the Application for Medical Device Registration in China
The regulation also contains a checklist based on requirements that the application form shall meet. These including the following points:
- The application form should contain all applicable information and also the data verification code.
- If the applicant is a domestic entity, a copy of the business license should be submitted.
- If the applicant is a foreign entity, the certificate issued by the appropriate national regulating authority should be provided. In this case, it would also be necessary to provide all information regarding the manufacturing facilities, as well as details about other countries where the medical device subject to review is allowed to be imported, marketed and used.
- If the medical device in question falls within the scope of the “innovative” concept, a special application procedure should be used.
- The medical device manufacturer shall declare the compliance of its product with the national standards.
- The application should be accompanied by a self-assurance statement of the authenticity of the information submitted by the applicant.
- The applicant shall also declare that the medical device complies with the requirements set forth by the applicable national regulations on medical devices, including the classification rules.
- If there is an application for the priority review, such an application should be properly justified.
- If the medical device has multiple models with different specifications, the manufacturer shall also describe in detail the differences between the models. In particular, the CMDE recommends providing such information in the form of a comparison table, accompanied by pictures, charts, and explanatory texts.
Exiting the Registration Process and Re-applying
The second regulation issued by the CMDE is dedicated to a situation where the authority identifies that the medical device in question should be assigned to another category, and other requirements should be applied. In this case, the ongoing registration process should be terminated, and the medical device manufacturer shall re-apply for registration. According to the document, the applicant would have to provide the additional information required by the authority.
Summarizing the information provided above, the new regulations issued by the CMDE are intended to introduce additional structure and standardization to the medical device registration submission review.
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