State Registration for medical devices in accordance with the national requirements of the Republic of Belarus and EAEU requirements

State Registration/Renewal/Variation approval for medical devices in accordance with the national requirements of the Republic of Belarus and EAEU requirements.

The admission into circulation of medical devices is carried out after passing the state registration procedure, which includes an examination of the submitted registration dossier, an inspection of the production site (for newly announced manufacturers) and the conduct of sanitary and hygienic tests.

PromoSolution provides services for the GAP analysis of documents provided for registration / renewal / variation approval procedures, preparation of registration dossier and full support of the mentioned procedures, including of samples for testing and documents for inspection, inspection support.