1. PM06-CAT-G17 V4 01/07/2012 REGULATION IN THE PROGRESS, CHALLENGES AND OPPORTUNITIES OF MEDICAL DEVICE IN COLOMBIA. Dr. Blanca Elvira Cajigas General Director Ottawa, Canada 7 Septiembre de 2013

2. PM06-CAT-G17 V4 01/07/2012 I.REGULATION PROGRESS IN MEDICAL DEVICES IN COLOMBIA. II.CHALLENGES AND OPPORTUNITIES FOR STRENGTHENING THE REGULATION OF MEDICAL DEVICES IN THE REGIONAL AREA CONTENTS

3. PM06-CAT-G17 V4 01/07/2012 I.REGULATION PROGRESS IN MEDICAL DEVICES IN COLOMBIA.

4. PM06-CAT-G17 V4 01/07/2012 MEDICAL DEVICES’ BACKGROUD IN COLOMBIA 1979 2008 2010 LAW 9 NATIONAL SANITARY CODE RESOLUTION 4396 OF 2008. MANUAL FOR TECHNICAL SANITARY CONDITIONS – FOR ESTABLISHMENTS MANUFACTURES FOR MEDICAL DEVICES ON MESURE (PRESCRIPTION) FOR VISUAL AND EYE HEALTH RESOLUTION 1319 MANUALS FOR GOOD MANUFACTURING PRACTICES FOR MEDICAL DEVICES ON MEASURE FOR PROSTHETICS AND ORTHOTICS IN ORTHOPEDICS 1993 DECREE 2092 INTRODUCTION MEDICAL RECORDS 2005 2007 RESOLUTION 4002 MANUAL IMPLEMENTATION STORAGE CAPACITY AND PACKAGING CERTIFICATION DECREE 4725 MEDICAL DEVICES HEALTH RECORDS RESOLUTION 4816 REGULATING THE NATIONAL TECHNOVIGILANCE PROGRAM DECREE 1030 REGULATION REQUIREMENTS THAT NEEDS TO MEET THE MEDICAL DEVICES ON MEASURE (PRESCRIPTION) FOR VISUAL AND EYE HEALTH LAW 100 BIOMEDICAL TECHNLOGY 1986 2011 LAW 1438 POLITICAL MD HEALTH TECHNOLOGY ASSESSMENT INSTITUTE (HTAI) Momentous AdvanceThe country needs a National Policy for MD

5. PM06-CAT-G17 V4 01/07/2012 REGISTRATION AND SURVEILLANCE OF MEDICAL DEVICES 1986 5% Of Medical Devices Were Inspected 2005 100% Of Imported and Manufactured Medical Devices are subject to Inspection Syringes, Gauze, Dialysis Equipment, Catheters. Commission reviewing concepts New MD: Eliptics, treadmills, hospital beds, decubitus mattress, wheelchairs

6. PM06-CAT-G17 V4 01/07/2012 MEDICAL DEVICES REGULATIONS Medical Records System, Marketing Approval and Surveillance. Decree 4725 of 2005 Storage capacity requirements and / or Conditioning and the manual is adopted. Resolution 4002 of 2007 Requirements for Visual and Ocular Health Devices Decree 1030 of 2007 Technical and Sanitary Manual MD visual and ocular health. Resolution 4396 of 2008 Requirements are established for enrollment and GMP adopts MD Manual for Prosthetics and Orthotics. Resolution 1319 of 2010 STANDARD ON MEASURE National Technovigilance Program Resolution 4816 of 2008 National Technovigilance Program Resolution 4816 of 2008

7. PM06-CAT-G17 V4 01/07/2012 Decree 4725 of 2005 Resolution 4002 of 2007 Decree 1030 of 2007 Resolution 4396 of 2008 Resolution 1319 of 2010 STANDARD ON MEASURE CURRENT REGULATIONSREGULATIONS IN PROGRESS Good Clinical Practices Good Manufacturing Practices Coding Standards Technical Amendment. "Glasses Ready to Read" National Surveillance Reagent Program MEDICAL DEVICES REGULATIONS WHAT ARE WE IN?

8. PM06-CAT-G17 V4 01/07/2012 STORAGE AND CONDITIONING CERTIFICATE (RESOLUTION 4002 of 2007) Cleaning and disinfection Facilities Maintenance Pest Control Procedure for decontamination and / or product disposal SANITATION AND HYGIENE Traceability Destruction of medical Devices Assistance and technical support for users Attention to complaints and reports Product Recalls Managing of non- compliant products SANEAMIENTO E HIGIENE MONITORING AND CONTROL Audit quality and inspections Document control Record Control QUALITY SYSTEM Reception and Inspection of the products Storage Conditioning (packaging, labeled) Distribution Approval or release for distribution STORAGE AND CONDITIONING

9. PM06-CAT-G17 V4 01/07/2012 Establishments involved in manufacturing, semi-developed, packaging and packing Medical Devices, for its operation must comply with the GMP, in its effect issued by the Ministry of Health and Social Protection. (Article 8, Decree 4725 of 2005) HEALTH CONDITIONS 3 years

10. PM06-CAT-G17 V4 01/07/2012 Good Manufacturing Practices - GMP Manual of Good Manufacturing Practices for Medical Devices. Ministry of Health and Social Protection - INVIMA. Bearing in mind the International Standards ISO 13485 and ISO 14971. Directive 93/42/EEC, and International Countries Concerning FDA, ANMAT. Proposed Resolution Designed Annex 1. Manual of Good Practices Designed Annex 2. Inspection and Certification Guide WHAT ARE WE IN?

11. PM06-CAT-G17 V4 01/07/2012 EXTERNAL ORTHOPEDIC PROSTHETIC AND ORTHOTICS (RESOLUTION 1319 OF 2010) INVIMA Competencies – Health Secretaries Profile and requirements for the Technical Department The time of registration for manufacturers (Adding 3 months) Manual of Good Manufacturing Practices for the development and adjustment of prescription medical devices for orthopedics prosthetic and orthotics, Ministry of Health and Social Protection - INVIMA. WHAT ARE WE IN?

12. PM06-CAT-G17 V4 01/07/2012 GOOD CLINICAL PRACTICE - GCP Legislative project is looking for regulating the use of medical devices in human research and medical device prototype. Creation of Proposed Resolution WHAT ARE WE IN?

13. PM06-CAT-G17 V4 01/07/2012 CODING STANDARDS Regulatory Project Creation emerges from Resolution 2981 of 2011, aiming at identifying and classifying medical devices according to international standards of coding that allows exchange of information between authorities in health surveillance, tracking, management, pricing, spending. International standard usesInternational code ECRI and GHTF Database Structure Health Record Codes Code Structure UDI (Unique device Identification) WHAT ARE WE IN? www.gmdnagency.orgwww.gmdnagency.org ; GMDN User Guide. Version 2012.1. Comprehensive guide to the Global Medical Device Nomenclature ( ISO 15225 de 1997 - ultima versión 2012. ISO TS 20225 de 2001)

14. PM06-CAT-G17 V4 01/07/2012 INSPECTION PATTERN, MONITORING AND CONTROL RISK APPROACH MD COMPONENTS OF RISK ANALYSIS Resolution No. 1229 of 2013. Establishes the model for the Inspection, Monitoring and Sanitary Control for products and Human consumption used.

15. PM06-CAT-G17 V4 01/07/2012 METHOD APPLIED The risk map construction of medical devices and other technologies has been carried out in four (4) steps: MEDICAL DEVICE RISK MAP STEP 1: Development of complete list of variables. STEP 2: Characterization and selection of the most influential variables STEP 3: Balancing of most influential variables STEP 4: Prioritization of establishments covered by Control, Inspection and Surveillance (CIV) with risk approach www.mindjet.com SAURIN, William. Tomado de Michel Godet (1993) “De la anticipación a la acción. Manual de prospectiva y estrategia”. Marcombo. Barcelona. Eneko Astigarraga. EL MÉTODO DELPHI. Universidad de Deusto, Facultad de CC.EE. y Empresariales. ESTE Mundaiz, 50. E-20.080 Donostia - San Sebastián. ANÁLISIS ESTRUCTURAL con el método MICMAC, y ESTRATEGIA DE LOS ACTORES con el método MACTOR. Jacques ARCADE, Sirius - Michel GODET, CNAM Francis MEUNIER, CNAM - Fabrice ROUBELAT, CNAM. 2002.

16. PM06-CAT-G17 V4 01/07/2012 PHASEN°MOST INFLUENTIAL VARIABLES MANUFACTURING1 Risk Classification of Medical Device REGULATORY PROCESS AND AUTHORIZATION TO ENTER THE PRODUCT TO THE MARKET 2 Establishments Certified (SCC*, Health Conditions, Production Capacity) 3 SCC* Certification Valid 4 Do you have Health Registry? 5 Health Registry Condition (IN USE) 6 Health Registration suspension 7 Health Registration Cancelation MARKETING(Storage and distribution) 8 Total or partial closure of the establishment 9 Visits Control, Inspection and Surveillance 10 Time since the last visit 11 Complaints 12 Freeze up the product 13 Confiscation 14 Determining the conformity of the product by carrying out Medical Devices Laboratory tests USES - CONSUMPTION AND DISPOSAL 15 Alerts 16 Recall 17 Reporting Adverse Events and Incidents 18 Signal Method Results MEDICAL DEVICE RISK MAP PHASES LIFE OF CYCLE *SCC - Storage and Conditioning Certificate

17. PM06-CAT-G17 V4 01/07/2012 II.CHALLENGES AND OPPORTUNITIES FOR STRENGTHENING THE REGULATION OF DEVICES IN THE REGIONAL AREA

18. PM06-CAT-G17 V4 01/07/2012 1º Challenge. Strengthen the Interaction between Regulation and Technology Assessment Technology assessment based on scientific evidence, taking into account cost-effectiveness, cost-utility and cost- benefit, to incorporate into benefit plans, once you have entered the country. (Law 1438 of 2011, Chapter V, Articles 92-96). HTAI Evaluate the quality, safety and effectiveness of health technologies to authorize its introduction in the country and subsequent marketing and the use.

19. PM06-CAT-G17 V4 01/07/2012 HTAI - INVIMA SUPPORT THE ASSESSMENT PROCESS HEALTH TECHNOLOGIES EFFECTIVENESS Security Alerts Recall Report SIGNAL adverse events – causally related to - MD Quality shows Laboratory Tests 1º Challenge. Strengthen Interaction between Regulation and Technology Assessment

20. PM06-CAT-G17 V4 01/07/2012 1º Challenge. Strengthen Interaction between Regulation and Technology Assessment PAHO INVIMA HTAI MSPS "Coordinated and Comprehensive Work" Active Participation in the "retrospective Scoping Study on the interaction between health technology assessment and the regulation of medical devices focused maternal and child, case: Colombia"

21. PM06-CAT-G17 V4 01/07/2012 Universal Coverage Health Technology Utility Cost Analysis Cost Benefit Analysis Cost Effectiveness Analysis Four (4) Basic Political Principles of Medical Devices EQUALITY 1º Challenge. Strengthen Interaction between Regulation and Technology Assessment Health Technology Assessment Institute

22. PM06-CAT-G17 V4 01/07/2012 22 The national health technology policy must consider four (4) basic principles: Availability (ready to use) Accessibility (easy access) Appropriateness (Adequate and appropriate) Affordability (can be achieved) EQUALITY 2º Challenge. National Medical Device Policy

23. PM06-CAT-G17 V4 01/07/2012 Tecnología Biomédica Three (3) Components: I Strategic, conceptual and policy Components view strategies action plans indicators monitoring and evaluation system II Technology Assessment Component Evaluation of medical technologies applied to medical devices Medical device needs assessment 2º Challenge. National Medical Device Policy

24. PM06-CAT-G17 V4 01/07/2012 Tecnología Biomédica III Regulatory and Operational Management Components of the Life cycle of Medical Devices Good Manufacturing Practices Good Clinical Practice Coding Medical Devices Process. Incorporation Device Procurement Process Biomedical Equipment Maintenance Process Inventory Management Biomedical Equipment Computerized maintenance management Disposal of Medical Devices Process 2º Challenge. National Medical Device Policy

25. PM06-CAT-G17 V4 01/07/2012 Tecnología Biomédica 1. Good Manufacturing Practices for Medical Devices. 2. Good Clinical Practice for Medical Devices. 3. Coding of Medical Devices. 4. Good Manufacturing Practices for Medical Devices on Health Hearing Aids. 5. Amendment of Resolution 4396 of 2008. (Reading Glasses) 6. Modification Resolution 1319 of 2010 (Prosthetics and Orthotics). 7. Model Implementation Inspection, Monitoring and Control. 8. National Medical Device Policy 3º Challenge. 2013 Regulatory Agenda

26. PM06-CAT-G17 V4 01/07/2012 ACADEMIC FIELD HEALTH FIELD PRODUCTIVE INDUSTRY ECONOMIC FIELD How can you design and implement a successful Medical Device Policy?

27. PM06-CAT-G17 V4 01/07/2012 THANK YOU FOR YOUR ATTENTION www.invima.gov.co Doctor Blanca Elvira Cajigas General Director INVIMA Email: bcajigasa@invima.gov.cobcajigasa@invima.gov.co Carrera 68 D No. 17-11 - Bogotá, D.C. Colombia. Telephone: (1)2948700