State registration of medical devices and medical equipment in Belarus

1. Application for state registration (re-registration) of products containing: — full and exact names of the applicant, manufacture and products for registration (see Appendix 1);

2. Obligation for installation, repair, warranty and service maintenance of the applied medical devices and medical equipment, signed by the manufacturer of medical devices and medical equipment applied for the state registration (re-registration);

3. Notarised power of attorney of the foreign manufacturer;

4.* Documents certifying the quality of the applied for medical device issued in the country of origin (original or a copy duly certified )

5. Instruction for medicinal use duly certified by the manufacturer of the applied for medical device or medical equipment;

6. Data sheet of the medical device or medical equipment, information about the guaranteed service life of a certain model of the medical device or medical equipment applied for the state registration (re-registration) containing relevant information as of the date of the application;

7. Statement about presence (indicating the amount) or absence of precious metals in the medical device or medical equipment signed by the manufacturer of the medical device or medical equipment applied for the state registration (re-registration).

* — certificates of conformity for the quality management system, certificates of conformity for products, free sale certificates, manufacturer’s declarations of conformity, registration certificates, — sanitary and hygienic tests reports for medical devices and medical equipment.

Additional information on the products quality may be provided to decide whether clinical trials are required (not required): - documents confirming clinical trials in the country of origin, results of clinical evaluation (who conducted the studies and where they were conducted, the number of patients, have all the indications stated in the operating manual for medical equipment been involved) or other documents confirming clinical efficiency of the applied for medical devices and medical equipment; - documents showing turnover of medical devices and medical equipment in domestic and foreign markets; - documents (or copies thereof duly certified) showing side effects of medical devices and medical equipment.

All the documents shall be translated into Belarusian or Russian and duly certified.

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