Medical Device Registration in
Ministry of Health
Medical Device Regulation
Regulations on the procedure of the state registration of medicinal products, medical devices and medical equipment and the issue of a registration certificate.
Class I, IIa, IIb and III
- Determine the device classification
- Appoint an Authorized Representative
- Submission of the Application for registration, copies of the certificate of state registration of the applying company, registration dossier, and a sample of the medical device, if necessary.
- Primary (preliminary) examination.
- The signing of the Agreement between the Applicant and the State Center for Expertise and Standardization of Medicinal Products.
- Receipt and payment of examination bills.
- After payment is confirmed, registration materials and samples are sent for specialized expertise to the structural units of the State Centre for Expertise and Standardization of Medicinal Products
- At the meeting of the Expert Council a decision to register the medical device and to use it in medical practice is made.
- The decision of the council and the materials are forwarded to the Head Department for Quality Control of Medicinal Products and Medical Equipment of the Ministry of Health for the publication of the Order related to the registration.
- The registration certificate is produced and issued to the Applicant after the Order is signed.
- Power of Attorney
- Manufacturer’s Information
- Registration certificates issued by other competent authorities
- IFUs, Labels or User manuals
- Technical documents
- Clinical studies protocols
- Legalized copies of compliance documents
- Stability data
- Promotion materials
- Quality, efficiency and safety protocols of medical devices
Class I – 6 months
Class II – 6-9 months
Class III – 12 months