Application for state registration (re-registration) of a medical device and state registration of changes made in the registration documents of a medical device
4.1. State registration (re-registration) of the medical device and state registration of the changes made in the registration documents of the medical device includes the stages of making an application in the manner determined by part 4 of these Rules, conducting the examination by the Institution and issuing the registration certificate to the medical device in the manner determined by Part 7 of these Regulations, in accordance with the “Rule for conducting the examination of medicinal products, including simplified examination” approved by the Resolution No. 502 of the Cabinet of Ministers of the Republic of Azerbaijan dated December 25, 2019, in accordance with clause 4.4 of these Rules,
4.2. According to Article 1.0.8 of the Law, in order to obtain state registration (re-registration) of medical devices with a higher, high and (or) medium risk level, the following shall be submitted by the applicant to the Ministry together with the application in Appendix No. 1 of these Regulations:
4.2.1. a copy of the document confirming the production right of the manufacturer of the medical device and its annex;
4.2.2. a notarized copy of any of the following documents translated into Azerbaijani:
4.2.2.1. a document confirming the state registration of the medical device in the country where it is manufactured, and if it is not state registered in that country, the document (documents) confirming its state registration in another country (countries);
4.2.2.2. a certificate on free sale or export of a medical device (if any);
4.2.3. a brief description of the fields of application, purpose and component of the medicinal product provided by the manufacturer of the medicinal product;
4.2.4. information on the labeling and packaging of the medical device provided by the manufacturer of the medical device (color models of packaging and labels, content in Azerbaijani);
4.2.5. if the medicinal product provided by the manufacturer contains a medicinal substance, the composition, quantity of that medicinal substance, information on the compatibility of the medicinal substance with medicine;
4.2.6. biosafety information provided by the manufacturer;
4.2.7. a notarized copy of the document provided by the manufacturer containing information on the validation of testing methods and packaging, test results for containing microorganisms (bioburden rate), pyrogenicity and sterility, and process validation in relation to sterile medical devices, translated into Azerbaijani by a notary;
4.2.8. declaration of compliance with the safety and effectiveness requirements of the production of the medical device, indicating the risk level given by the manufacturer;
4.2.9. a copy of the certificate on the quality management system of the production of the medical device issued by the manufacturer;
4.2.10. Documents stipulated in Articles 18.2.1-18.2.3 of the Law of the Republic of Azerbaijan “On Licenses and Permits”.
4.2.11. a copy of the document issued by the manufacturer on the usability of medical devices (in relation to used medical devices).
4.3. Subclauses 4.2.1, 4.2.2, 4.2.8 and 4.2.9 of these Regulations do not apply to medical devices produced in the Republic of Azerbaijan, subsection 4.2.5 does not apply to medical devices used to obtain information by examining samples from the human body in a test tube, subsection 4.2.6 does not apply to medical devices that do not come into contact with the human body.
4.4. If there is information about the medicinal substance in the documents submitted during the state registration of medicinal products prepared in a pharmaceutical form with a certain dose, consisting of natural, synthetic substances and their combinations, in order to determine the quality, effectiveness and safety of the medicinal substances in its composition, before being registered with the state, the “Analytical Expertise Center” public legal entity (hereinafter – the Institution) must be examined.The implementation of this expertise is carried out according to the “Rule for conducting the expertise of medicinal products, including simplified expertise” approved by the Resolution No. 502 of the Cabinet of Ministers of the Republic of Azerbaijan dated December 25, 2019.
4.5.. The documents or information that must be attached to the application in clauses 4.2 and 4.3 of these Rules by the institution are obtained in accordance with clause 3.6 of these Rules.
