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Ministry of Health

 

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: -

 

Control / Monitor
Person
Items / activities regulated
PRE-MARKET
PLACEMENT ON-MARKET
POST-MARKET
PRODUCT SALE AFTER-SALE / USE
MANUFACTURER / IMPORTER / EXPORTER
VENDOR VENDOR & USER
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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