[CFDA Alerts] Five more medical devices failed to be registered, how to avoid or proceed with it?

Five more medical devices failed to be approved in China from 22^nd to 30^th September. The medical devices as follows:

1. Low frequency electronic pulse therapeutic apparatus
2. Visual acuity screening instrument for children
3. Ceiling lamp (used for dental surgery)
4. High potential therapeutic apparatus
5. LgE assay kit

Why these registrations didn’t pass the technical evaluation in CFDA?
Generally, the termination decision on technical evaluation will be made by CFDA when the registrations meet one of the following conditions:

1. The product is not managed as medical device in China;
2. Applicant asks to terminate the application;
3. The application item shall not be registered according to relevant regulations;
4. The application documents of the item include forge and false content proved by evidences;
5. The registration is in wrong managing class.
6. It is not submitted as right registration type;
7. Conducting clinical trial in non-clinical base without approval;
8. Conducting registration test in non-approved inspection center or inspection range without approval;
9. The applicant does not submit supplementary documents without warrant of written document while exceed 20 workdays of time limit; or submitting the supplementary documents within time limit, but the supplementary is incomplete and without warrant of written document for non-supplemented and modified part.
And applicant modifies the content of standards, instruction and so on (such as important performance index, application, etc.), and do not make any explanation.
10. The application documents of the application item do not meet the Accepted Standard of Register Application Documents of Domestic Class III and Imported Medical Device;
11. The application item do not meet the requirements of safe and effective;
12. The content of application documents is disorganized and inconsistent;
13. The content of application documents do not conform to application item.
14. The application item has other serious problems.

How to proceed with when the termination decision made by CFDA?

1. Ask CFDA for re-evaluation within 20 working days from receiving the decision. The reexamination content is limited to the original items and application materials. CFDA will decide whether to do the re-evaluation within 30 working days dating from receiving the application and give a written notice to the applicant.
2. Apply for administrative reconsideration or administrative litigation.

How to avoid situation on registration terminated?

1. Applicants shall make sure that whether their product is medical devices or not and the product is safe and effective.
2. Applicant shall make sure the application dossier meets the data requirements of medical devices registration, it is complete and right, and the content is clear and consistent. The content also shall conform to application item.
3. The registration test and clinical trial shall be conducted in Chinese institutes designated by CFDA.
4. Applicant shall submit the supplementary documents with a one-time in time (within one year). There will be required to submit a written explanation once the registrant can’t supplemented within the prescribed time.