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

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

3. 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?

4. 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

5. 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

6. 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

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

8. 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

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

10. 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

11. 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

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

13. 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
Ministry of Health Malaysia

14. 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

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

16. 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

17. MeDVER
Registration is
FREE
FREE OF CHARGE

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