| Regulatory Authority | Agency for Medicinal Products and Medical Devices | Ministry of Health |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | I, IIa, IIb and III |
| Medical Device Regulations | Medical Devices Legislations | Click Here |
| Device Classification Guidelines |
Rulebook on the detailed conditions and manner of classifying medical devices | Click Here |
| Registration Process | Medical Device Registration | Click Here |
| Registration Timeline | 3 months |
| Requirement of Authorized Representative | Yes |
| Language Requirement | Labels must be in Macedonian and English Language |
| Labeling Requirements |
Rulebook on the content and manner of labeling of the outer and contact packaging, as well as the instructions for use of the medical device "Official Gazette of the Republic of Macedonia", No. 24/09 | Click Here |
| Clinical Trials Information |
Submitting a request for clinical testing of medical devices
Article 10
The applicant for the clinical trial of the medical device performs the following tasks.
1) prepares the complete documentation required for obtaining approval for the clinical trial of the medical device as well as the documentation required for amendment and addition to the protocol, i.e. the approval for the clinical trial of the medical device
2) determines the main examiner who signs a statement that he agrees with the proposed protocols by performing the tasks related to the clinical examination of the medical device
| Click Here
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| Database | Medical Device Register | Click Here |
| Fees for Submission |
1. Application review fees: Fees depend on the number of devices, class, and if the devices hold CE certificates.
2. The fee for issuing a notification for amending or supplementing the approval for putting the medicine on the market, that is, for requesting changes that have occurred, and for change of type IA and type IB (per parameter) 160 euros in Denar equivalent for type II change - 240 euros in Denar equivalent, for a change for which a new approval is issued, 240 euros in Denar equivalent
3. Fee for issuing approval for transfer of approval to another holder 160 euros in Denar equivalent
4. Fee for issuing approval for upgrading the documentation for putting the deck into circulation for one pharmaceutical form, strength and size of package 512 euros in Denar equivalent,
| Click Here
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| Reportable Incidents |
Rulebook on the manner of reporting adverse effects during the use of medical devices, the types of reactions they cause, the actions of healthcare professionals and suppliers, as well as the manner of organizing the system for monitoring adverse effects and reactions from medical devices "Official Gazette of the Republic of Macedonia", No. 100/16 | Click Here |
| Advertising and Promotions |
Advertising of medical devices can be done through: 1) advertising in public media, via the internet, advertising in public places and other types of advertising intended for the general public (delivery of advertising material by mail, visits, etc.), 2) promotion of the medical device to healthcare professionals who prescribe the medical device, through direct information in professional journals and other forms of promotion, 3) sponsoring scientific and promotional gatherings in which members of the professional community participate. | Click Here |
| Additional Information | The form of the request for registration of medical devices class I (Form No. 1), class IIa, IIb, and III (Form No. 2), in vitro diagnostic medical (Form No. 3) and AIMD medical devices (Form no. 4) in the Register of Medical Devices in the Republic of Macedonia. |