Documents checklist
1. Manufacturer’s business registration2. ISO 13 485 (or ISO 9001)
3. Certificate MDD 93/42/ЕЕС (or another applicable Directive for medical product)
4. Declaration of conformity
5. List of components
6. Technical file (that was used for CE certification, including test reports, clinical evaluation, risk management)
7. Product User’s manual (with all accessories and reference numbers description)
8. Marking label draft for each product
9. Product photos including accessories and product components
Factory inspection is required and is carried out by 3−4 specialists from Belarus Ministry of Health:
- Represenative of Belarus Ministry of Health «Center for Examinations and Tests in Health Service «
- Represenative of applicable clinic (1 or 2 doctors depending on the project)
- Represenative of «Center for Hygine, Epidemiology and Public Health»