Guidelines on submission of documentation for registration of CE marked

medical devices in the Register of Medical Devices

I. When submitting a request for a registration of CE marked medical device in the

Register of Medical Devices, the Applicant (Proposer) shall submit the following
documentation to the Agency for Medicinal Products and Medical Devices of Serbia:

1. Applicant’s memorandum of request (cover letter), which may refer to several medical
devices of the same class and category, from the same manufacturer;
2. Completed part of the form referring to the registration of a medical device in the
Register of Medical Devices for the appropriate category or class of medical device
(Form 1 and Appendix 1) - it is necessary to submit also in electronic form (CD, USB,
etc.);
3. Manufacturer's Declaration of Conformity (original or notary-certified copy);
4. CE certificate, except for medical devices of Class I and for other In vitro diagnostic
medical devices (original or notary-certified copy);
5. QMS certificate - quality management system - EN ISO 13485 et al. (original or
notary-certified copy);
6. Proof that the medical device is approved for sale in the country of manufacture - Free
Sale Certificate (original or notary-certified copy);
7. Proof of third party insurance against consequences while using a medical device -
insurance policy (original or notary-certified copy);
8. Proof of domestic manufacturer of a medical device: a permit issued by a ministry
responsible for health affairs on the production of medical devices (a certified copy);
9. Proof that the authorized representative is manufacturer’s agent or distributor, as well as
any other natural or legal person headquartered in the Republic of Serbia, in accordance
with the law: appropriate contract with the manufacturer and translation certified by the
court interpreter;
10. Written mandate from a manufacturer confirming that the authorized representative may
act on his behalf and conduct proceedings before the authorities of the Republic of
Serbia, in accordance with the Law on Medicines and Medical Devices and regulations
adopted for the enforcement of this law (original or notary-certified copy);
11. Proof that the distributor of manufacturer has a license for the wholesale distribution of
medical devices, issued by the ministry responsible for the healthcare (certified copy);
12. Decision on registration of the applicant in the Register of the Business Registers
Agency;
13. The appearance of an outer and inner package of a medical device in foreign language
or a sample of a medical device; the appearance proposal of external and internal
packaging for medical devices that the patient uses independently, also in Serbian
language; for medical devices intended to be used by professionals (professional use)
also a sticker proposal.
 14. A manual for medical devices of foreign origin in foreign language and a proposal of
manual for medical device of foreign and domestic origin in Serbian language, signed by
a clinical doctor - it is necessary to submit also in electronic form (CD, USB, etc.).
15. In accordance with Article 14, Paragraph 1 of the Rulebook on how to register a medical
device in the Register of Medical Devices and the application for registration of a medical
device in the Register of Medical Devices, during the process of substantive assessment
documentation, Agency may request additional information, depending on the type of
medical device, which relate to: specification of product testing, methods of product
testing, certificate of analysis for In vitro diagnostic medical devices.

II​. If certain documents, which are still valid, have been submitted in earlier applications for
obtaining a marketing authorization or earlier application for the registration of a medical device
in the Register of Medical Devices, a copy of that document should be provided, with a note on
which request the document has been submitted.

III​. Documentation of the medical device should be submitted in one copy, in Serbian and/or
English, in one marked registry.