How to apply for and obtain the medical device registration certificate under new CFDA regulations ——Interview with Ms Cindy Fu from CIRS MD Regulatory Technical Team

On 20^th May 2015, China CFDA released the list of 71 imported medical devicesregistration to be approved, among which, one class II medical device registration was completed by CIRS. This is a milestone showing the technical breakthrough of CIRS in the registration of medical device in China under new CFDA regulations. The writer of this article has given an interview to Ms Cindy Fu from CIRS who is in charge of project management and dossier preparation for medical device, in order to try to help the industry to cope with the problems encountered during the process of the dossier preparation and technical evaluation under new regulations. It is expected to shorten the registration period significantly if the registrant could solve these problems prior to dossier submission.

Q1: Could you please give a brief introduction to this medical device?
A: According to the CFDA regulations, this device is classified into a Class II medical device in China and its classification category is 6804: Ophthalmic Instruments. The general name of this device is called Intraocular Lens Implant System, which has the intended purpose for the fold and assisted implantation of intraocular lens, and exhibits the main features as inactive, sterilized, single used and short-termed contact with human body. Fortunately, based on the old SFDA regulations, this device is free of clinical trial, which would save a lot of cost and duration for our client.

Q2: Could you please briefly describe the registration process for us? For example, when did you start this project and how long does this project take to complete?
A: Well, this project started from 20^th Feb 2014 and ended on 11^th May 2015. At the very beginning, our work was to gather the basic information of the product, and draft the technical requirements, labels & instructions until we received samples from the client. After then, we delivered samples to the CFDA qualified laboratory, the testing started from the middle of Mar 2014 and everything just went very well, we gained the final report on the middle of July 2014. During the testing period, we finished preparing all other dossiers, such like risk analysis, clinical evaluation, research information, basic requirements list, etc. It was on the beginning of August that our submission was accepted by CFDA, and on Jan 2015 we were asked to add some supplementary to the submission, lastly on 11^th May 2015 we received the CFDA registration license and delivered it with all dossiers those used for CFDA registration to the client.

Q3: What the supplementary materials have the expert panel requested during the first technical evaluation?
The supplementary materials requested by the expert panel typically focused on two aspects:

Since this device owns a variety of models, so the expert paned asked for the very detailed supplementary description and figures of every typical model.
Second supplementary is the bio-compatibility test, it was asked to give the bio-test report of every material which directly or indirectly contacts human body.

Q4: Are there any technical innovations during this registration project?

The submission of this product was between the expiration of former regulations and the implementation of new clinical regulations, interestingly, this device is exempted from clinical trial according to former regulations, however, it is unknown if it will be exempted from clinical trial under new regulations. So just in case, we intentionally abandon the bio-test to shorten the testing duration, thus we submitted the registration application before the new regulations implemented, and then we conducted the bio-test as it was asked by the expert panel.
Regarding there are many models of this product, and it will cost a lot if we conduct testing of each model, so we just select several very typical models to do the testing and this saved much cost and duration; also for the bio-compatibility test, we listed all materials those directly or indirectly contact human body, and figure out how many different materials are there, thus we don’t need to repeat the bio-test for the same material.

Q5:What are your suggestions for enterprises to shorten registration period?
A: For foreign companies to shorten CFDA registration duration, I would like to give four suggestions:

Company should take CFDA regulatory requirements into consideration during the R&D of their products, such as product standards and clinical requirements;
Be very strict with the study of bio-compatibility, sterilization, cell toxicity and so one, since CFDA is paying great attention to the safety of medical devices;
For active devices, the EMC test and electricity safety test has to be included in the testing report;
For novel devices those have very amazing function, it is strongly suggested to provide well-known public literatures to play as theoretical basis.

Q6: What main points does the expert panel focus on during the technical evaluation?
Well, during the technical review, there were two points significantly emphasized by the expert panel. One was the safety, the other was the effectiveness. Safety was revealed in the product testing, which included physicochemical properties and bio-compatibilities. Effectiveness was revealed in the clinical evaluation, which gave the proof and confirmation to show how the product performed in terms of its intended purpose.

Q7: According to your experience in medical device registration under new CFDA regulations, what is the most difficult obstacle/ part of the process?
Compared to the former regulations, the new regulations intensify the supervision in terms of clinical trial and manufacturing site spot check.

Under the management of the former regulations, implantable medical devices those imported to China didn’t need to conduct clinical trial in China if there was already same product that had been approved by SFDA, but under the new regulations, if the overseas product is not listed in the catalogue of medical devices exempted from clinical trial and is unable to build clinical evaluation report, then it has to do the clinical trial in China.
Different from the former regulations, CFDA builds an expert panel that will be responsible for the overseas manufacturing site spot-check under the new regulations. Moreover, the new regulations will charge the company for the administrative fee, while parts of the administrative fee will be leveraged to pay the overseas spot-check travelling fee, so it is much more possible for CFDA experts to go out and check the manufacturing quality system.

Q8: What are the post-registration obligations for registrants after the approval of medical device registration?
Actually, CFDA is focusing more and more on the post-market supervision from 2014, and obligations for company to follow are as below:

The information of products imported to China has to be totally same with the information used in the registration, such as manufacturing address, agent information, instruction, label, packaging, etc.
Sale agents of the product in China have to be equipped with qualified distributing license.
Company has to apply for the change to CFDA when the information of company/agent/product changes, otherwise, penalty has to be paid for the non-corresponding information.
Any adverse events shall be reported to CFDA immediately, and effective measures shall be taken to deal with adverse events as soon as possible.
Company has to recall the product that does not meet the requirement, or it will be charged for 5 to 10 times penalty.

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