The notification on the implementation of medical devices and in vitro diagnostic reagent registration management practices related issues-SFDA No. 247 [2015]

Provinces, autonomous regions and municipalities Food and Drug Administration:

The newly revised "Medical Device Registration" (China Food and Drug Administration Order No. 4) and "in vitro diagnostic reagent registration management approach" (China Food and Drug Administration Order No. 5) was October 1, 2014 since implementation.

To further improve the implementation of the convergence work regulations, relevant issues are hereby notified as follows:

First, on the implementation of the new mandatory standard product review before accepting questions
For applying for registration of medical devices, the mandatory technical requirements of the standard and its products referenced changes, in addition to the General Administration of the release, the implementation of standards document as otherwise provided in the implementation of the new standards before accepting registration inspection of products, still according to the original standard inspection, review and approval. Since the implementation of the rehabilitation standards, enterprises should implement the new standards, the product should comply with the new standards.

Second, on the continuation of the problem relates to the mandatory registration standard changes
When continuation of the registration, enterprises in the product remain unchanged, to adapt to changes in standards and modifications mandatory technical requirements and other licensing matters set forth in the registration certificate circumstances (such as performance structure and composition, etc.), you may submit an application in accordance with the continuation of the registration, However, medical devices shall be submitted by the inspection agency issued the inspection report in line with the mandatory standards.
Continuation of registration review, it is necessary under the new mandatory standards additional information, food and drug supervision and management department can require companies to supplement relevant information, the review confirmed the product does not comply with the new standards will not be a continuation of compulsory registration.

Third, on the biological tests of medical devices
Biological evaluation of (a) medical devices involved in the biological tests, the biological tests reported by the applicant at the time of submission of an application for registration as research data.
(B) to carry out biological tests, should be entrusted with a medical device testing accreditation, biology laboratory within the scope of its seizure in accordance with the relevant standards for testing. Biology laboratory test reports issued abroad, shall be accompanied by an overseas laboratory indicate its compliance with GLP laboratory quality assurance documentation requirements.

Fourth, on the supplementary testing inspection agency
Ask a supplementary inspection requirements for registration review, it should be tested in the original inspection bodies.

Fifth, on the continuation of the original registration certificate registration and change of convergence
Business registration certificate of the original application for registration change, register change files posted registration certificate number of the original registration certificate number; the same time, such as business registration certificate for an extension of the original registration, registration required to continue issuing new registration certificate number. In this case, in order to continue registration of the associated registration certificate to the registration change files, you can specify the original registration certificate number in the remarks column in the continuation of the registration certificate, regardless of this registration document approved by the time change before or after the approval of the continuation of registration They are able to continue with its registration approved registration certificate common use.

Sixth, on the information submitted clinical evaluation of medical devices
According to "Medical Device Clinical evaluation of technical guidelines" Article 6 of the clinical evaluation, such as the use of the production process, clinical data and other information with the variety of medical devices, the applicant shall submit the same variety of medical equipment production technology, clinical data and other information use authorization.

7, on the fill permit
Replacement medical device registration certificate shall include in replacement of Medical Device Registration Certificate remarks column "xxxx xx xx day replacement. Original xxxx xx xx day registration certificate issued void."

8, on the purpose of registration of medical devices
Approved registered medical device means the medical device registration certificate and annex defines the content is consistent and in the production of medical device registration certificate validity of medical devices.

Food and Drug Administration of Work
November 4, 2015