medver 20061107

							             Experiences with

                MeDVER
               (Voluntary Registration Scheme for
                Medical Devices Establishments)




Consultation Session on the Preparation of Medical Devices Regulation
                       Palm Garden, Putrajaya
                          7 November 2006
MeDVER
  http://www.medicaldevices.gov.my/




   Consultation Session on the Preparation of Medical Devices Regulation
                          Palm Garden, Putrajaya
                             7 November 2006
Topics
 Background
 Statistics
 Feedback from Industry
 Conclusion
      Consultation Session on the Preparation of Medical Devices Regulation
                             Palm Garden, Putrajaya
                                7 November 2006
Background: What is
   MeDVER?

  Voluntary web-based registration for medical
   devices establishments
  Registry
  Administrative process
  Identification
  An official public consultation forum
  Launch: 12 January 2006
         Consultation Session on the Preparation of Medical Devices Regulation
                                Palm Garden, Putrajaya
                                   7 November 2006
Background: What is
    MeDVER?

Not an approval system
      submission and registration numbers do
      not constitute an admission or
      agreement by the Ministry of Health to
      denote approval of an establishment
      and its devices


          Consultation Session on the Preparation of Medical Devices Regulation
                                 Palm Garden, Putrajaya
                                    7 November 2006
Background: What is
     MeDVER?

    Confidence and image building process
    Familiarization
    Preparation for transition to mandatory phase
    Information network




         Consultation Session on the Preparation of Medical Devices Regulation
                                Palm Garden, Putrajaya
                                   7 November 2006
Background: Who
   should register?

  Manufacturers of medical devices
  Exporters and importers of medical devices
  Distributors and vendors of medical devices




         Consultation Session on the Preparation of Medical Devices Regulation
                                Palm Garden, Putrajaya
                                   7 November 2006
Background: How to
   register?

  Step 1: Account Creation (MeDVER-01)
  Step 2: Establishment Registration (MeDVER-02)
         Section A: Establishment Information
         Section B: Person Responsible
         Section C: Medical Device Information
         Section D: Post-Market Requirements
         Section E: Application Declaration
  On-line http://www.medicaldevices.gov.my

            Consultation Session on the Preparation of Medical Devices Regulation
                                   Palm Garden, Putrajaya
                                      7 November 2006
Statistics: Type of
  Establishments


                   Establishment type                         Number           %
                   Distributor/Vendor                            228          84.1
                   Importer                                      129          47.6
                   Manufacturer                                   76          28.0
                   Exporter                                       33          12.2
                   Others                                         12           4.4
                   Total number of                               271
                   establishments
      Consultation Session on the Preparation of Medical Devices Regulation
                             Palm Garden, Putrajaya
                                7 November 2006
Statistics: Device
  Category
                Device category                                      Number   %
                Active implantable devices                               209   6.3
                Anaesthetic & respiratory devices                        278   8.3
                Dental devices                                            93   2.8
                Electromechanical devices                                219   6.6
                Hospital hardware                                         26   0.8
                In-vitro diagnostic devices                              557 16.7
                Non-active implantable devices                           152   4.6
                Opthalmic & optical devices                               52   1.6
                Reusable instruments                                      61   1.7
                Single-use devices                                     1452 43.6
                Technical aids for disabled persons                        3   0.1
                Diagnostic & therapeutic radiation devices                16   0.5
                Others                                                   214   6.4
                Total                                                  3,332 100.0
     Consultation Session on the Preparation of Medical Devices Regulation
                            Palm Garden, Putrajaya
                               7 November 2006
Statistics: Pre-market
          approval/clearance
                 No
Others;
 2.3%
              approval;     Australia;
                             1.5%                     Approval/   Number %
                                                   clearance from
                4.4%

                             Canada ;
                              1.0%
                                                  Australia            60 1.5
                                                  Canada               39 1.0
  US; 44.9%
                     EU; 44.3%
                                                  EU                1,737 44
                                                  Japan                60 1.5
                                                  US                1,759 44.9
                Japan;                            Others               90 2.3
                 1.5%

                                                  No approval         172 4.4
                          Consultation Session on the Preparation of Medical Devices Regulation
                                                 Palm Garden, Putrajaya
                                                    7 November 2006
Statistics: Post-Market
  System
                                               ISO13485:1996, 6,
     ISO13485:2003,                                 2.2%
        41, 15.1%
                                                                 ISO9001:2000, 51,
                                                                      18.8%




                                                                        Others, 31, 11.4%
                            No post-market,
                              142, 52.4%




      Consultation Session on the Preparation of Medical Devices Regulation
                             Palm Garden, Putrajaya
                                7 November 2006
  Feedback from Industry
                                                                                    Section A
Total number of                                                              (Establishment); 4; 3%
feedback: 143                             Others; 23; 16%                          Section B (person
                                                                                  responsible); 6; 4%


                                                                                 Section C (Medical
                         System/security; 39;                                   device info); 19; 13%
                                27%


                                                                                   Section D (Post-
                                                                                    market); 7; 5%




          Application status; 14;                                      Registration/genera ;
                   10%                                                        31; 22%

                   Consultation Session on the Preparation of Medical Devices Regulation
                                          Palm Garden, Putrajaya
                                             7 November 2006
       Timeline
      Develop Medical Devices
      Act and Regulations

                                    Voluntary Registration

                                                                   On-line Registration &
                                                                   Mandatory Licensing

                                                                        Implement Vigilance
                                                                             System

                                                                                             Enforcement

Q3    Q4    Q1   Q2   Q3     Q4     Q1      Q2      Q3     Q4      Q1     Q2      Q3     Q4 Q1 Q2 Q3 Q4
     2004          2005                       2006                         2007                    2008
                           Consultation Session on the Preparation of Medical Devices Regulation
                                                  Palm Garden, Putrajaya
                                                     7 November 2006
Conclusion
  Less than 50% registered
  Many issues, especially post-market
  Please register and get ready for the
   mandatory phase



          Consultation Session on the Preparation of Medical Devices Regulation
                                 Palm Garden, Putrajaya
                                    7 November 2006
         Thank You




Consultation Session on the Preparation of Medical Devices Regulation
                       Palm Garden, Putrajaya
                          7 November 2006