Same Variety Products Comparison Clinical Evaluation Difficulties

Under the CFDA regulation, the class II & III medical device not included in ‘The Catalogue of Class II & III Medical Devices Exempted from Clinical Trials’ can not be exempted from Clinical Trials. And the same variety product comparison is one of the conditions can be exempted from clinical trials for the clinical trial required medical devices, but it will have certain difficulties.

Unable to find enough clinical literature.
If the imported products are class II medical devices in the original oversea listing country, it is not necessary to do the clinical trials before listing. One of the other conditions is that the product listing time is not long enough and the reference literature are also limited.

The conclusions of the clinical literature are different that the supporting evidence is not strong enough.
Although some products can find a lot of clinical literature, the conclusions of the clinical literature are not the same so they still can't be the powerful clinical evidence. Also the CFDA Appraisal Center will focus on how persuasive the evidence is but not the amount of clinical literature. If the clinical literature are persuasive and keep consistent on the conclusion, a small amount of clinical literature will be enough. Otherwise, hundreds of clinical literature with different conclusions can not be strong supporting evidence.

The difficulty of obtaining Chinese subaggregatea data.
Under the CFDA regulation, the clinical data collecting should including the Chinese population. It will always be a challenge for the imported products clinical trial data commection. On the one hand, there are not so many Chinese/Asian population involved in the European and the United States clinical trials. On the other hand, some European and the United States clinical trials will not clarify the racial of the data. As a result of this situation, it is really hard to pull out the Chinese/Asian population from the whole database. If it is unable to provide Chinese/Asian population in medical device clinical evaluation report, CFDA Appraisal Center will request the applicant to do the clinical trials in China.

Up to now, the medical device regulations are keep improving. Medical device registraton required clinical trials in China shows a positive phenomenon.

Related links

* If you have any comments or questions, please contact us at md@cirs-group.com.

We have launched a LinkedIn newsletter to keep you up to date on the latest developments across the chemical industry including food and FCMs and personal and home care.

Same Variety Products Comparison Clinical Evaluation Difficulties

Same Variety Products Comparison for the Clinical Trials Exemption