MEDICAL DEVICE REGULATION IN BULGARIA

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According to Bulgaria’s legislation, the submission of documents for a medical device clinical trial approval shall be made to the Bulgarian Drug Agency (BDA).

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MEDICAL DEVICE REGISTRATION AND APPROVAL IN BULGARIA

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The following list of documents should be submitted to BDA:

1. Application form
2. Identification data for the medical device
3. Clinical trial design
4. Schedule of the clinical study
5. Declaration that the medical device complies with all relevant essential requirements excluding those which are object of clinical trial, and that all expected safety measures have been taken to ensure the safety and health of the subjects in the trial and of the investigating team;
6. Agreement template between the sponsor and the site;