The decision to refuse registration shall be justified. There may be reasons for this:
- There is no evidence that medical devices meet the requirements of the manufacturer’s documentation.
- Evidence of quality, effectiveness and safety of the medical device is not confirmed.
- The data on the effectiveness and safety of the medical device do not correspond to the data stated in the manufacturer’s documents.
- The risk of harm to health when using the medical device exceeds its effectiveness.
- A sample of the medical device has not been provided for the purpose of testing (study) for measuring instruments type approval, as well as failure to execute a contract (if necessary).
- Failure to provide full documents and/or unreliable information for the medical device.
- Failure to eliminate the identified violations and/or failure to provide documents upon request (if necessary).
Thus, if all requirements are met, registration is carried out in the shortest possible time. The legislative bases of all EAEU members and the terms of the agreements reached are taken into account, and their national and regional peculiarities are also taken into account.
Our staff will manage the registration and licensing of medical devices in the EAEU and guarantee compliance with the agreements. To use our services, please fill in the feedback form, send your contact details or call us back on the phone number given in the contacts.