11/11/2013

Obelis SA Obelis European Authorized Representative Center

Medical Device Regulatory Requirements For Malaysia

During the past few years the Malaysian government has been working on developing a novel regulatory system to cover medical devices. The Medical Device Control Division (MDCD), the responsible authority within the Ministry of Health, is therefore, developing and implementing the regulatory framework to manage medical devices (cosmetics are not included) on the Malaysian market.


The objective of the regulation is to:



  • Protect public health and safety;

  • To allow patient for earlier access to new technology for early detection, diagnosis, and treatment;

  • To facilitate trade and invigorate the medical devices industry


In 2005, the Ministry of Health launched the regulatory system and later on it announced the creation of a voluntary registration system, called MeDVER (Voluntary Registration Scheme for Medical Devices Establishments), which is a free, web-based program.
Manufactures, importers, exporters, distributor and vendors are all included as users of the system.


The new legislation bill has not yet become a law, therefore, in the mean time; the MeDVER scheme is on-going until the law gains legitimacy. According to the draft version, the new regulations will cover all stages of the entering of medical device products to Malaysia, including:



  • Design, development, clinical trials, manufacture & distribution, advertising, use & maintenance and disposal.


Non-local manufacturers will also need to maintain local representatives to retain their registrations.


Medical device registration is the responsibility of the manufacturerand local authorized representatives (LAR similar to the European Authorized Representative).


The registration process requires the submission of:



  • Technical Documentation (CSDT/ Common Submission Dossier Template & Technical File);

  • Declaration of Conformity (DoC)

  •  - Class A: self declaration of conformity;

  •  - Class B, C and D:



  1. Technical Evaluation – submission of CSDT;

  2. Technical File;

  3. Declaration of Conformity;


For imported products, CE marking or USFDA documentation must be adjunct regarded as experimental in their country of origin. The abridge route of medical device registration is applicable for imported devices which have already been approved by the relevant authorities to be marketed in the countries below:



  • US,

  • European Union,

  • Canada,

  • Australia,

  • Japan


Otherwise the assessment by the Regulatory Authority & CAB (conformity assessment bodies) is required.


In sum, Malaysia is undoubtedly moving toward a more regulated medical device market that requires more stringent regulatory compliance.


If you would like to know more about the registration of medical devices in Malaysia, contact us!