Hold Details, Easy Your Registration

On November, 25^th 2014, CFDA issued the 129^th notification named “Concerned Problems on Registration of Medical Devices (Including IVD)”, which gives the further guidance on details of medical devices registration during this transition period.

1. For the clinical requirement of general medical devices, you should pay attention to following matters:

• If your product is listed in the , you shall submit the equality proof materials between your product with the exempted product, which includes (a) comparison materials between your product information and description in the ; (b) statements and supporting materials between your product and domestic post-market device of the same species in the .
• If your product is not listed in the , but in line with the Article Seventeenth in the , which states clinical trial exemption requirements, you can submit clinical evaluation materials to CFDA and CFDA will determine whether your product can be exempted from clinical trial or not.
• If your product cannot be exempted from clinical trial, then you shall submit the clinical trial agreement, the ethics committee approvals, clinical trial programs and clinical trial reports after the completion of clinical trials.

2. For the clinical requirement of IVD reagents, you should pay attention to following matters:

• If your company has signed at least one clinical trial protocol before October 1, 2014, then you can submit materials as original requirements.
• If your company has not signed any clinical trial agreement before October 1, 2014, then only after you have obtained the qualified inspection report can you conduct clinical trials, the registration of IVD must strictly follow the newly revised regulations.
• Each clinical trial institute shall provide “Written Opinion of Ethics Committee’s agreement for carrying out clinical trials”; if no ethics committee, then must explain the absent of the ethics committee and provide ethical review of clinical trials.

3. Medical Device Registration Certificate will be faced with the continuous registration or the change, the change includes registration matters change (e.g. name and address of the applicant, or the agent, domestic manufacturing address etc.) and licensing matters change (e.g. product name, model, specification, structural composition, applicable range, technical requirements etc.) In view of these, what details we shall keep eyes on?

• When do the change of licensing matters, the testing report of changed technical requirement parts shall contain the pre-assessment.
• You can apply for the combined change of both registration matters and licensing matters, just fill two application forms respectively, and mark the note of “combination change”.
• You can apply for the combined application of both the continuous registration and the change before April 1^st 2015, just fill two application forms respectively, ensure that information in the Continuous Registration Application Form is in accordance with those in the original Registration Certificate, and finally note the “combination application”.

4. How to use original dossiers of registration

• For several registration applications of the same product, original dossiers shall be submitted with one of registration applications; when dossiers are required next time, just submit their copies and note where the source is.
• If original dossiers are not available when applying for the continuous registration, then the copies, explanation and consistence declaration shall be submitted.

All in all, there had been something significant change and new regulations issued in 2014, to comply with new regulations and to drive the market during this transition period, you must trace the regulation without any delay and strengthen the regulatory training of your staffs. Only if you are sensitive to regulations can you get rid of the risk.

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