Rules for medical devices

Law on Medical Devices („Official gazette of RS“, No. 105/2017)

1. Rulebook on Import of unregistered medical devices
(“Official Gazette of RS”, No. 39/2018)

2. Rulebook on Essential Requirements for medical devices
(“Official Gazette of RS”, No. 65/2018)

3. Rulebook on Registration of a medical devices

3a. Application for the registration of medical device
(“Official Gazette of RS”, No. 105/2017)

4. Rulebook on Determining the Status of a Product
4a. Annex 1 – Rulebook on Determining the Status of a Product
4b. Annex 2 – Rulebook on Determining the Status of a Product
(“Official Gazette of RS”, No. 105/2017)

5. Rulebook on Advertising a medical device
(“Official Gazette of RS”, No. 105/2017)

6. Rulebook on Suspention, Withdrawl and the Technical Assessment of a medical device on the market
(“Official Gazette of RS”, No. 105/2017)

Law on Medicinal Products and Medical Devices („Official gazette of RS“, No. 30/2010; 107/2012 and 113/2017-other law)

1. Rulebook on the Contents of the Application, and/or Documentation on the Approval of Clinical Trials for Medicines and Medical Devices, as well as the Method of Implementation for Clinical Trials of Medicines and Medical Devices
(“Official Gazette of RS”, No. 64/2011)

2. Rulebook on the method of reporting, collecting and monitoring adverse reactions to medicines
(“Official Gazette of RS”, No. 64/2011)