Recently, the Chinese Centre for the Evaluation of Medical Devices (CMDE) published two announcements concerning new procedures for the Medical Devices registration in China.
Announcement n°16 of 2020 on examination, archiving and review of documents
The CMDE announcement n°16 of 2020 lays down procedures and requirements that provide further regulation for issues concerning examination, archiving and review of documents for the registration of a device. This announcement integrates the requirements already published in the 2019 announcement n.42.
According to this announcement CMDE, during the revision of the documents, presents some suggestions and corrections useful for the applicant so that he can resubmit the application for registration complete with all the documents provided and respecting the indications that have been provided. In this way, the application can be accepted.
Announcement n°17 of 2020 on new withdrawal registration procedures for Medical Devices with a higher classification
The CMDE announcement n. 17 of 2020 lays down the procedures for the withdrawal and resubmission of registration for imported Medical Devices which were presented for registration as Class II devices but defined Class III Medical Devices after technical revision.
In those cases, the CMDE shell issue a non-approval document stating the reasons for not registering the device. A copy of this document must be included among the materials that the applicant submits in the application for registration of Class III medical device.
For what concerns the medical device registration fee, it is taken in to account the fee that the applicant had already paid for the application for registration of the device considered to be Class II.
Being however defined a Class III device, the applicant will also have to pay the difference fee.
Once the payment is confirmed, the CMDE initiates the review times of the application for registration.
Do you need any support for the Medical Devices registration in China?
Thema offers extra-EU international registrations services and support services for the registration of a medical device in China.
For more information on our services, you can contact us by sending an e-mail at the following address sales@thema-med.com.
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