According to Bulgaria’s legislation (LMD and the relevant regulations), the submission of documents for a medical device clinical trial approval shall be made to the Bulgarian Drug Agency (BDA) and the Ethics Committee for Multicentre Trials (ECMT) in case of a multi-centre study, or to the relevant Local Ethics Committee in case of a single-centre study.
The application documents can be submitted to the BDA simultaneously with the submission to the LEC/ECMT.
Clinical trials of implantable medical devices, active implantable medical devices, invasive medical devices for long-term use in class IIa and IIb and medical devices in class III which take place on the territory of the Republic of Bulgaria can commence upon receiving a positive stand from the Ethics Committee for Multicentre Trials (ECMT) or from the Local Ethics Committees (LECs) and an approval from the Executive Director of the Bulgarian Drug Agency(BDA).
Clinical trials of medical devices different from the ones listed above which take place on the territory of the Republic of Bulgaria can commence upon a notification to the Executive Director of the BDA, if the relevant Ethics Committee has given a positive stand.
Submission to Ethics Committee:
The following documentation should be submitted:
1. Administrative documents;
2. Information about the subject
3. Documentation on the study protocol;
4. Documentation on the investigated medical device;
5. Documentation about the technical specifications and the personnel;
6. Data on the financing and administrative organization of the study.
If the EC finds the submitted documentation incomplete it notifies the applicant within 14 days and sets a deadline for removing the omissions.
Within 30 days after submission of the valid documentation EC passes a stand which is presented to BDA and the applicant.
Submission to BDA:
The following documentation should be submitted to BDA within 60 days before the commence date of the clinical trial in order to get an approval for clinical trials of implantable medical devices, active implantable medical devices, invasive medical devices for long-term use in class IIa and IIb and medical devices in class III:
1. Application form
2. Identification data for the medical device on paper and CD;
3. Clinical trial design, which describes the purpose, scientific, technical and medical rationale for conducting the trial, its scope, methodology and organization of the trial and the number of devices;
4. Start date, final date and schedule of the clinical study;
5. Positive stand by the EC in case that the applicant has submitted the application to EC and BDA consequently;
6. 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;
7. Insurance policy covering the responsibility of the sponsor and the investigator for causing material and non-material damages to the subjects in the trial during and as a result of conducting a clinical study;
8. Agreement template between the sponsor and the site;
9. Document for paid fee;
On simultaneous submission of the applications to EC and BDA, the applicant can submit a stand under item 5 after its receiving but not later than 60 days since the submission to BDA.
Within 60 days after submission to BDA, the
Executive Director notifies in writing the applicant of its stand. In case of lack of notification within the set timeframe of 60 days, the Sponsor can commence the clinical trial immediately.