| Introduction to Medical Devices Establishments (MeDVER)
Malaysia In February 2005, a decision was made by the Malaysian
Government to regulate medical devices in Malaysia. The
Ministry of Health Malaysia is responsible for
developing and implementing a regulatory framework to
control medical devices in Malaysia. The aims of the
medical devices regulation are: -
- To protect public health and safety
- To allow patients for earlier access to new technology
for early detection, diagnosis and treatment
- To facilitate trade and invigorate the medical devices
industry
Registration of establishments and their medical devices
is considered to be the most basic level of regulatory
control of devices in the market. This registration
system will identify the devices, the responsible party
and will facilitate any regulatory activity. What is a
medical device?
'Medical device' means any instrument, apparatus,
implement, machine, appliance, implant, in vitro reagent
or calibrator, software, material or other similar or
related article: -
a) Intended by the manufacturer to be used, alone or in
combination, for human beings for one or more of the
specific purpose(s) of: -
- diagnosis, prevention, monitoring, treatment or
alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or
compensation for an injury,
- investigation, replacement, modification, or support of
the anatomy or of a physiological process,
- supporting or sustaining life,
- control of conception,
- disinfection of medical devices,
- providing information for medical or diagnostic purposes
by means of in vitro examination of specimens derived
from the human body;
and
b) Which does not achieve its primary intended action in
or on the human body by pharmacological, immunological
or metabolic means, but which may be assisted in its
intended function by such means.
Essential requirements of safety and performance of
medical devices
General requirements: -
- Design and manufactured that will not compromise the
clinical condition or safety of the patients, or the
safety and health of the users
- Conform to safety principles
- Achieve the performance intended
- Performance characteristic not adversely affected during
life time
- Benefits outweigh any side effects for the performance
intended
Who Should Register?
The following parties who operate their businesses in
Malaysia are invited to participate in this voluntary
scheme.
- Manufacturers of medical devices
- Exporters and importers of medical devices
- Distributors/vendors of medical devices
How to register to MeDVER for Oversea Suppliers?
MeDVER is a web-based registration system. All
applications shall be made on-line.
It consists of 2 parts: -
|
Part 1 |
Part 2 |
| Account Creation |
Establishment Registration: -
- Section A - Establishment Information
- Section B - Person Responsible
- Section C - Medical Device Information
- Section D - Post-market Requirements
- Section E - Application Declaration
|
Activities to be regulated: -
| |
PRE-MARKET |
PLACEMENT ON-MARKET |
POST-MARKET |
|
Control / Monitor |
PRODUCT |
SALE |
AFTER-SALE / USE |
| Person |
MANUFACTURER /
IMPORTER / EXPORTER |
VENDOR |
VENDOR & USER |
|
Items / activities regulated |
Product attributes |
After-sale
obligations |
Surveillance /
vigilance |
| - |
Safety and performance standards |
|
| - |
Fulfill after-sale obligations |
| - |
List of product available / in use |
|
| - |
After-sale service |
| - |
User training |
| - |
T&C / maintenance / calibration |
| - |
Performance monitoring |
| - |
Incident reporting |
| - |
Decommissioning / disposal |
| - |
Product alerts / recall |
|
| Manufacturing |
Advertisement |
|
| - |
Quality Management System |
| - |
Risk assessment |
|
| - |
No misleading / fraudulent advertisements |
|
|
|
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