III EMERGENCY SITUATIONS

IV INFORMATION CONFIDENTIALITY

V ESSENTIAL REQUIREMENTS FOR THE MEDICAL DEVICE

1. Placing a Medical Device on the Market and into Service
Essential Requirements
2. Assumption of Conformity
3. Applicable Application
4. Assessment of Conformity
5. Foreign Documents and Marks of Conformity
6. Freedom of Movement, Medical Devices for Special Purposes
7. Incorrectly Placed Mark of Conformity
8. Protective Clause
9. Medical Device Manufactured in a Healthcare Institution for Use in that Healthcare Institution

VI TYPES OF MEDICAL DEVICES

VII APPOINTED BODY

VIII CLINICAL TRIAL

IX REGISTRATION OF MEDICAL DEVICES

X MANUFACTURE OF THE MEDICAL DEVICE

1. Manufacturer
2. Obligations of the Manufacturer
3. Issuing a License for the Manufacture of a Medical Device
4. Amendment, Addition and Renewal of the Manufacturing Authorisation of a Medical Device
5. Annulment of the Decision Granting a Licence for the Manufacture of a Medical Device
6. Registration of the Manufacturer or Authorised Representative of the Manufacturer
7. Performing the Manufacture of a Medical Device
8. Notifying the Ministry or the Agency

XI MEDICAL DEVICES MARKETING

1. Volume of Marketing
2. Wholesale Trade of Medical Devices
- 1) Requirements for Issuing a Marketing Authorization for Wholesale Trade of Medical Devices
- 2) Application for Issuing a Licence for the Wholesale Trade of Medical Devices
- 3) Issuing a Licence for the Wholesale Trade of Medical Devices
- 4) Register of Issued Licences for Wholesale Trade of Medical Devices
- 5) Amendment, Addition and Renewal of the Marketing Authorisation for Wholesale Trade of Medical Devices
- 6) Annulment of the Marketing Authorisation for Wholesale Trade of Medical Devices
- 7) Reasons for Revocation of the Licence for the Wholesale Trade of Medical Devices
- 8) Control of Compliance with the Guidelines of Good Practice in Distribution
3. Import of a Medical Device that is not Registered in the Republic of Serbia
- Importers' Obligations
4. The Obligation of Continuous Supply of the Market
5. Carrying out Marketing of a Medical Device
6. Withdrawal of the Medical Device from the Market
7. Records
- 1) The Contents of the Records
- 2) Collecting and Processing Data on Marketing and Consumption of Medical Devices
8. Plan for Urgent Withdrawal of the Medical Device from the Market
9. Informing the Ministry
10. Destruction of Medical Devices
11. Retail Trade of Medical Devices
- 1) Retailing
- 2) Amendment, Addition and Renewal of the Marketing Authorisation for Medical Devices in Specialised Shops
- 3) Retail Conditions

XII LABELLING AND INSTRUCTIONS FOR USE OF THE MEDICAL DEVICE

XIII MEDICAL DEVICE ON THE MARKET

1. Surveillance of the Medical Device on the Market
2. Data on Incidents after Placing the Medical Device on the Market : Vigilance System
3. Technical Assessment of the Medical Device on the Market

XIV PROCEDURE FOR PROTECTION AGAINST THREAT TO PUBLIC HEALTH

XV ADVERTISING THE MEDICAL DEVICE

1. The Form of Advertising
2. Comparative Promotion of the Medical Device
3. Advertising of the Medical Device to the General Public
- 1) The Mode of Advertising to the General Public
- 2) Advertising to the General Public
4. Promoting the Medical Device to the Professional Public
- 1) Promoting to the Professional Public
- 2) Free Samples
- 3) Sponsoring Scientific and Promotional Events
5. Advertising Terms

XVI MEDICAL DEVICES FOR DUAL USE

XVII SUPERVISION IN THE FIELD OF MEDICAL DEVICES

1. Execution of Inspection Supervision
2. Inspector
- 1) Conditions for the Work of the Inspector
- 2) Inspector's Legitimacy
- 3) Authorisation of the Inspector
- 4) Minutes and the Decision on Performed Inspection
3. The Duties of the Person Subject to Inspection Supervision
4. Cases in which the Obligations and Responsibilities of the Manufacturer of a Medical Device Apply to Importers, Wholesalers and Other Persons

XVIII PENAL PROVISIONS

XIX TRANSITIONAL AND FINAL PROVISIONS

Legal Acts in English