Ministry of Health Malaysia VOLUNTARY REGISTRATION FOR MEDICAL DEVICES ESTABLISHMENTS MeDVER Ministry of Health Malaysia

Briefing Content Introduction What is MeDVER? How to participate? Ministry of Health Malaysia

Scope of regulation: All phases of medical devices life cycle Design & development Decontamination, decommission, disposal Distribution, supply, sale, advertising Manufacture, import/export Installation, T&C, maintenance, calibration, repairs Packaging, labeling, storage Operation, Usage PLACEMENT ON-MARKET POST-MARKET PRE-MARKET Ministry of Health Malaysia How is the Act to be enforced?

Survey the usage and inventory Implement control and enforcement THE PLAN Standards Guidance Notes/ Code of Good Practices Regulations Act Survey the usage and inventory Establish policy directions Input from stakeholders Registration and Vigilance System Resources allocation Implement control and enforcement Ministry of Health Malaysia

Voluntary Registration Implement Vigilance System Timeline Q1 Q2 Q3 Q4 2004 2005 2006 2007 2008 Develop Medical Devices Act and Regulations Voluntary Registration On-line Registration & Mandatory Licensing Implement Vigilance System Enforcement Ministry of Health Malaysia

MeDVER An economic and effective approach to the control of medical devices in the interest of public health and industry. GHTF Ministry of Health Malaysia

Voluntary Registration Administrative process Registry Identification- provide a way to be accountable Evidence of status An official public consultation forum Ministry of Health Malaysia

Voluntary Registration Is not an approval system Assignment of submission number and registration number does not in any way constitute an admission or agreement by the MOH to denote approval of an establishment and its products Ministry of Health Malaysia

Voluntary Registration Benefits of Participation Confidence and image building process Familiarization Preparation for transition to mandatory phase Information network Ministry of Health Malaysia

Medical Device Meets essential principles of safety and performance – 6 general requirements + 12 design and manufacturing requirements Includes device-drug combination Ministry of Health Malaysia

Medical Device Not drug Not cosmetics Not food supplements Not counterfeit Not questionable *Establishment responsibility to ensure none of the above Ministry of Health Malaysia

Establishment Manufacturer Importer and exporter Distributor and vendors Ministry of Health Malaysia

1. MeDVER-01 Account Creation Flowchart Homepage Click on “MeDVER Login” Click Account Registration Form (MeDVER-01) Complete the Registration Form Then click “Create Account” Display Error Message and Prompt to resubmit Reject System Validation Approved Account created Auto notification to user by email Ministry of Health Malaysia

2. MeDVER-02 Establishment Registration Homepage Click Account ‘MeDVER Login’ Login to MeDVER Using the login ID and password Logout Form Section: A. Establishment Info. B. Person Responsible C. Medical Device Info D. Post-Market Info E. Declaration Application Registration Main Menu Save Draft Declare and Submit Application Form Form Incomplete System Check Completeness Display Incomplete Message Submission Successful. System Display Application No. Ministry of Health Malaysia

How to Participate http://www.medicaldevices.gov.my/ Ministry of Health Malaysia

MeDVER 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 Ministry of Health Malaysia

MeDVER Registration is FREE FREE OF CHARGE

We welcome your feedback Thank You We welcome your feedback Ministry of Health Malaysia