Medical devices are allowed for import and placing on the market of the Republic of Belarus only after state registration. At present the Application for registration may be submitted either under the “national” procedure or under the “centralized” EAEU procedure.
The procedure for national registration is described below. You can get information about registration under the EAEU’s unified rules by clicking on the link.
New registration
The procedure for national state registration of medical devices has been approved by Regulation No. 254 dated 01.04.2015 “On state registration (re-registration) of medical devices and medical equipment” and Regulation No. 41 dated 04.12.2019 “On requirements to documents submitted for state registration (re-registration) of medical devices and medical equipment”.
Foreign manufacturer must designate an Authorized representative at the territory of Belarus, as entity, responsible for claims. The Applicant for registration may be a person who manufactures or places an order for the manufacture of medical devices and medical equipment.
Expert assessment for the purpose of registration is carried out by the RUE “Center for Expertise and Testing in Healthcare”.
Registration dossier
The registration dossier for foreign medical devices consists of the application for registration, protocols or acts on the manufacturer’s letterhead for sanitary and clinical tests issued by health care organizations or signed by the head of the manufacturer, documents confirming the quality of medical devices certified in the country of manufacturer, as well as the conclusion of RUE “Center for Expertise and Testing in Health Care” on the compliance of medical devices and medical equipment with the requirements of the Republic of Belarus.
The registration dossier is submitted in English, with some sections translated into Russian or Belarusian.
Labeling and instructions for use (user’s manual) are submitted and approved in Russian and/or Belarusian.
Registration procedure
Registration procedure starts with submission of the Application to the competent authority. After payment of the state fees competent authority starts assessment of the documents and can inquire specific studies or actions, including:
- initial examination of documents;
- specialized expert examination of documents;
- inspection of the manufacturer (if necessary);
- sanitary-hygienic tests of medical devices and equipment (if necessary);
- technical tests (if necessary);
- clinical trials (if necessary).
Time to achieve registration should not exceed 150 calendar days, including the time required to answer on the deficiency letters.
After positive conclusions on above mentioned assessments and studies are granted:
- The Applicant submits the registration dossier and the conclusion of the Commission on the results of technical activities to the Ministry of Health of Belarus;
- The Ministry of Health reviews the submitted documents and make a decision on the registration of the medical device;
- The Ministry of Health issues the Registration Certificate.
The duration of the registration procedure is from 15 to 30 days.
Registration certificate is issued for 5 years.
Inspection of the manufacturing site
The procedure for inspection of manufacturing site is approved by Order No. 636 dated June 8, 2017 “On approval of instructions on procedure for inspection of industrial production of medical devices and medical equipment”. Inspection is required during the first state registration of a site performing a batch release.
Inspection is carried out by a group of state experts.
The Applicant of registration should pay for the costs of the inspection activities, as well as transport and accommodation expenses.
The results of the inspection do not have an expiration date. Periodic monitoring of compliance with manufacturing conditions is not carried out.
Language and labeling
The package labeling, instructions for use (user’s manual) are submitted and approved in Russian or Belarusian language. The choice of language is at the discretion of the Applicant.
Labeling of a medical device for Belarusian market should contain:
- name and description of a medical device (type, brand, model, article);
- name of the manufacturer of the medical device and the production site;
- name and address of the manufacturer’s Authorized representative on the territory of Belarus;
- manufacturing date (year and month);
- use before date (year and month), if applicable;
- serial number (catalog number) or batch code (if available);
- the word “STERILE” for a sterile medical device;
- sterilization method;
- information that the medical device is intended for disposable use (for disposable medical devices, medical devices);
- storage and/or operating conditions.
Renewal of registration
Renewal of registration of medical devices is performed in the following cases:
- Expiration of the Registration Certificate’s validity period.
- Change of the name of the medical device;
- Reorganization or change of the name of the legal entity of the manufacturer;
- Change of the country of manufacture;
- Changes in the manufacturing process and quality control of the medical device.
Renewal of registration due to expiration will lead to the issue of the registration certificate with the same number, but extended for 5 years validity period. Renewal due to the changes will cause issue of the amended certificate with same number and validity.
Cratia provides professional services of registration of medical devices in Belarus. We have an excellent knowledge of national legislation, necessary experience and resources.
To start cooperation or get advice, please contact us by phone: +38 068 064-78-31, +38 044 223-61-67, by e-mail: info@cratia.ua, or visit our office.