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Voluntary Registration for Medical Devices Establishments (MeDVER)


Introduction

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

  

What is MeDVER?

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. In this respect, the Ministry of Health Malaysia has launched the Voluntary Registration Scheme for Medical Device Establishments (MeDVER) in Malaysia in early 2006, as an initial step towards the implementation of medical devices regulation.

MeDVER is the voluntary registration scheme for establishments dealing with medical devices in Malaysia. It is a web-based registration system. All applications shall be made on-line. It consists of 2 parts; namely

      • Part 1:  the account creation system; and 
    • Part 2: the system for obtaining information pertaining to medical devices establishments with respect to company profile, person responsible, medical devices particulars and pre and post-market details.

  

What MeDVER is not? 

MeDVER is not an approval system. Assignment of submission number and registration number does not in any way constitute an admission or agreement by the Ministry of Health Malaysia to denote approval of an establishment and its devices.

Why MeDVER?

The implementation of MeDVER is a confidence building stage whereby establishments dealing with medical devices in Malaysia are encouraged to participate and register their establishments with MeDVER. MeDVER is designed to serve the following purposes; 

  • To familiarize all affected parties with the registration process
  • To gauge the readiness of medical devices establishments in conforming to the regulatory requirements
  • To prepare a smooth transition into the mandatory phase before the full enforcement of medical devices regulation
  • To obtain a profile of the Malaysian medical devices industry 

The implementation of MeDVER will continue until the draft Medical Devices Bill is approved by Parliament.

Who Should Participate and Register?

The following parties who deal with medical devices and operate their businesses in Malaysia are encouraged to participate in this voluntary registration scheme.

  • Manufacturers of medical devices
  • Exporters and importers of medical devices
  • Distributors of medical devices  

  

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.

Last Updated ( Thursday, 12 June 2008 )
 
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