BILATERAL SCREENING MEETING

Transcription

1 Negotiating Group for the Accession of the Republic of Serbia to the European Union - Chapter 28, Consumer and Health Protection BILATERAL SCREENING MEETING Chapter 28 Consumer and Health Protection Brussels, 3-4 February 2015

2 Negotiating Group for the Accession of the Republic of Serbia to the European Union - Chapter 28, Consumer and Health Protection MEDICAL DEVICES Chapter 28 Consumer and Health Protection Brussels, 3-4 February 2015

3 MEDICAL DEVICES ACTIVE IMPLANTABLE MEDICAL DEVICES IN VITRO DIAGNOSTIC MEDICAL DEVICES

4 CONTENT I II III IV V LEGAL FRAMEWORK (NATIONAL) LEGAL FRAMEWORK IN EU TRANSPOSING AND HARMONIZATION INSTITUTIONAL FRAMEWORK ADMINISTRATIVE CAPACITY FUTURE PLANS AND CHALLENGES

5 I. LEGAL FRAMEWORK (NATIONAL)

6 LEGAL ENVIRONMENT Medical devices in RS are governed by: Law on Medicines and Medical Devices (OG RS No. 30/10, 107/12) Rulebooks

7 RULEBOOKS IMPLEMENTED BY ALIMS 1) Rulebook on the Procedure for the Registration of a Medical Device with the Medical Devices Register and the Contents of the Application for the Registration of a Medical Device with the Medical Devices Register (OG RS No. 57/11, 101/14, 111/14) 2) Rulebook on advertising of medicinal products or medical devices (OG RS No. 79/10) 3) Rulebook on classification of medical devices (OG RS No. 46/11) 4) Rulebook on the contents and method of labelling the outer and immediate packaging of a medical device and contents of the instruction for use of medical device (OG RS No. 64/11)

8 RULEBOOKS IMPLEMENTED BY ALIMS 5) Rulebook on the method of reporting, collecting and monitoring adverse reactions to medical devices (OG RS No. 64/11, 21/14) 6) Rulebook of the method of quality control of medicines and medical devices (OG RS No. 64/11, 63/13) 7) Rulebook on conditions for import of medicinal products and medical devices which do not have the marketing authorisation (OG RS No. 2/14, 14/14, 111/14) 8) Rulebook on the Contents of the Application, and/or Documentation for 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 (OG RS No. 64/11, 91/13)

9 RULEBOOKS IMPLEMENTED BY MOH 1) Rulebook on conditions for the production of medical devices (OG RS No. 10/12) 2) Rulebook on conditions for the wholesale of medicinal products and medical devices, the data entered in the Register of the wholesale, distribution of medicinal products and medical devices, as well as the mode of entry (OG RS No. 10/12) 3) Rulebook on conditions for the retail sale of medical devices in specialized stores (OG RS No. 10/12)

10 Jobs review of ALIMS regarding MD 1) Vigilance of medical devices 2) Clinical investigation of medical devices Medical Devices Department Issues authorizations for conduct of clinical investigation of MD, decide on variations of the authorisations, and/or protocols on the conduct of clinical investigation, and make decisions regarding the application of clinical investigation, and control the conduct of clinical investigation.

11 Jobs review of ALIMS regarding MD 3) Categorization and classification of MD s Medical Devices Department

12 Jobs review of ALIMS regarding MD 4) Registering in the Register of MD kept by the Agency, variations, renewal, transfer and removal from the register of MD Medical Devices Department 5) Approval for the imports of medical devices for treating a particular patient or group of patients, and medical devices for scientific research

13 Jobs review of ALIMS regarding MD 6) and 7) National Centre for Information on Medicines and MD 6) authorization to advertise MD 7) collecting and processing data on of MD traffic and consumption 8) Medical Devices Department 8) connects with international information networks about MD and with the agencies in charge of MD and their associations

14 Jobs review of ALIMS regarding MD 9) i 10) National Control Laboratory 9) participates in the planning and implementation of systematic control of MD s and taking random samples from the market 10) controls the quality of medical devices

15 MEDICAL DEVICES DEPARTMENT JOBS Medical Devices Vigilance Clinical investigations of MD Classification and categorization of MD Registering in the Register of MD, revision, supplementation and renewal Expert opinions in the field of MD Additional labels Importation of unregistered MD Entering the Master Data for MD MD/Vigilance Database/MD Register

16 MEDICAL DEVICES VIGILANCE *2014 change of Rulebook only serious adverse reactions and FSCA from abroad are reported *

17 MEDICAL DEVICES VIGILANCE Law on medicines and medical devices (OG RS No. 30/2010, 107/12) Rulebook on the method of reporting, collecting and monitoring adverse reactions to medical devices (OG RS No. 64/11, 21/14) EU Guidelines on a medical devices vigilance system MEDDEV 2.12/1 rev. 8

18 CLINICAL INVESTIGATION

19 Clinical investigations of MD Law on medicines and medical devices (OG RS No. 30/2010, 107/12) 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 (OG RS No. 64/2011) Good Clinical Practice in Clinical Trials (OG RS, No. 28/2008) EU Guidelines on a medical devices vigilance system MEDDEV 2.12/1 rev. 8

20 REGISTRATION IN THE REGISTER OF MD MD with CE mark Administrative procedures (30+60) Registration in the Register of MD - Declaration of Conformity - EC Certificate - ISO Certificate - Free sales Certificate (no testing is required)

21 Registration in the Register of MD The assessment of quality, safety and efficacy of MD (30+210) The transitional period (for domestic producers) MD without CE mark target MD with CE mark

22 NUMBER OF APPLICATIONS FOR THE REGISTRATION IN THE REGISTER OF MD

23 REGISTRATION IN THE REGISTER OF MD There are more than of medical devices on a Serbian market, which are registered in the Register of medical devices. Registration in the Register of medical devices is a way to ensure the quality, safety and efficacy of medical devices on Serbian market.

24 REGISTRATION IN THE REGISTER OF MD Keeping the register of medical devices ensures daily usage of medical devices that meet these standards which contributes to higher level of quality of health service, which is the goal of the Agency. Registration in the Register of MD enables the Agency to have insight into the all of medical devices on the market and to conduct surveilance over them. The list of medical devices registered in the Register of MD:

25 INTERNATIONAL COOPERATION AND PROJECTS

26 II. LEGAL FRAMEWORK IN EU TRANSPOSING AND HARMONIZATION

27 Harmonization with EU directives: (AIMD) 90/385/EEC The Active Implantable Medical Devices (MDD) 93/42/EEC The Medical Devices Directive (IVDD) 98/79/EC The In Vitro Diagnostic Device Directive 2007/47/EC amending directive (MDD)-93/42/EEC and (AIMD)-90/385/EEC

28 EU legislation (AIMD) 90/385/EEC The Active Implantable Medical Devices (MDD) 93/42/EEC The Medical Devices Directive (IVDD) 98/79/EC The In Vitro Diagnostic Device Directive 2007/47/EC amending directive (MDD) - 93/42/EEC and (AIMD) - 90/385/EEC Current status Partially Harmonised Partially Harmonised Partially Harmonised Partially Harmonised

29 CURRENT STATUS - Agency accepts all quality approvals, testings and standards that shows that medical device is in conformity with EU Directives for general medical devices, AIMDs and IVDs. - Regulation of Medical devices in RS is partially harmonized with EU directives for general medical devices, AIMDs and IVDs.

30 FULLY HARMONISED MEDICAL DEVICES - DEFINITIONS Directive 93/42/EEC (Article 1) Directive 90/385/EEC (Article 1) Directive 98/79/EC (Article 1) Directive 2007/47/EC amending 93/42/EEC and 90/385/EEC

31 CLASIFICATION OF GENERAL MEDICAL DEVICES FULLY HARMONISED Rulebook on the classification of general MD EU directives (93/42 EEC, 2007/47 EC) Reclassification of hip, knee and shoulder joint replacements: - Directive 2005/50/EC - OJ L 210/41 of 12/08/2005 Reclassification of breast implants: - Directive 2003/12/EC - OJ L 28/43 of EU guideline on the classification of medical devices (MEDDEV 2.4/1 Rev. 9, June 2010)

32 MEDICAL DEVICES VIGILANCE PARTIALLY HARMONISED Directive 93/42/EEC (Article 10) Directive 90/385/EEC (Article 8) Directive 98/79/EC (Article 11) Directive 2007/47/EC amending 93/42/EEC and 90/385/EEC Guidelines od a Medical devices Vigilance system MEDDEV rev 8

33 PARTIALLY HARMONISED Directive 93/42/EEC (Article 15, Annex X) CLINICAL INVESTIGATION OF MEDICAL DEVICES Directive 90/385/EEC (Article 10, Annex 7) Directive 2007/47/EC amending 93/42/EEC and 90/385/EEC

34 NON-HARMONISED Medical devices can be put on the Serbian market if they are Registered in the Register of medical devices; Agency may exceptionally issue the Licence for import of unregistered medical device for treatment of a certain patient or a group of a patients that are in a life threatening condition; Quality assessment and Marketing Authorization for non CE-marked medical devices; Quality control for every Batch of non CE marked medical device.

35 III. INSTITUTIONAL FRAMEWORK Law and rulebooks are implemented by: ALIMS Medicines and Medical Devices Agency of Serbia MoAEP Ministry of Health of the Republic of Serbia

36 IV. ADMINISTRATIVE CAPACITY Administrative Capacity ALIMS Total: employees 8 employees 10 employees 32 employees

37 ADMINISTRATIVE CAPACITY MINISTRY OF HEALTH The Sector for Medicines and Medical Devices, Controlled Psychoactive Substances and Precursors - Group for medicines and medical devices o 3 employees (2 М.Sc. Pharm and 1 М.Sc. Law) Inspection for medicines and medical devices o 9 employees (9 М.Sc. Pharm)

38 V. FUTURE PLANS AND CHALLENGES 1) Medical Devices Vigilance further development 2) Clinical investigations of MD raising the number 3) Further harmonization of MD legislation in the RS with EU (New Law on Medical Devices) 4) Registering in the Register of MD raising the number, and Importation of unregistered MD minimizing 5) International connectivity (HPRA, MHRA) and training through projects (Taiex, Twinning)

39 Thank you for your attention!