Product Registration

Medical Device Registration in Malaysia

In order to continue  selling  your medical device in Malaysia, you must first register your product with the Malaysian Medical Device Buerau (MDB). Registration with Malaysian regulators is done electronically through the web-based Medical Device Centralised Application System (MEDCAST), providing an easier way to submit the documents related to the registration.

Rocky Consulting provides comprehensive expertise and resources to support all phases of your Medical Device registration and approval effort. We fully support medical device regulatory compliance in malaysia, and can help you to ensure that your documents are ready for assessment by the CAB’s.

How Can we Assist you with Medical Device Registration :-

  • Study your products in detail
  • Review how your products are classified and registered globally in other countries
  • Analyze the dynamics of registering your products
  • Do a Gap analysis if necessary
  • Determine if local clinical trials are needed for registration
  • Prepare the CSDT dossier and related documents for assessment
  • Prepare other documents including QMS compliance, GDPMD/ ISO 13485 : 2003
  • Submit the dossier and supporting documentation to the local Authority for Approval
  • Answer questions in behalf of the Applicant
  • Meet with the Authority in Behalf of You to clarify any arising matters.
  • Obtaining Final Approval


The Malaysian medical device registration process

Malaysia’s medical device regulatory framework is similar to  Singapore. Major elements of the Malaysian system include a four-tier classification scheme, leveraging reference country approvals, and authorized representation requirements for foreign companies.

Medical devices are registered and categorised by class or risk as shown below, including some examples of each class:

  • A Simple – Low risk, surgical instruments, tongue depressor, liquid in glass thermometer, examination light, simple wound dressing, oxygen mask, stethoscopes and walking aids.
  • B Low – Moderate risk, hypodermic needles, suction equipment, anaesthetic breathing circuits, aspirator, external bone growth stimulators, hearing aids, hydrogel dressings, patient controlled pain relief, phototherapy unit and X-ray films.
  • C Moderate – High risk , lung ventilator, orthopaedic implants, baby incubator, blood oxygenator, blood bags, deep wound dressing, defibrillator, radiological therapy equipment and ventilators
  • D High risk, Pacemakers & their leads, implantable defibrillators, implantable infusion pumps, heart valves, neurological catheters, vascular prostheses & stents.

Other Requirements :

  • A licensed Conformity Assessment Body (CAB) must certify registration applications for devices listed in Class B,C,D . For Class A device Self declaration is acceptable
  • Foreign firms with no local presence in Malaysia must appoint a Malaysia Authorized Representative with Good Distribution Practice Medical Device certification

Rocky Consulting can support the registration of your medical device in Malaysia

Although device registration in Malaysia involves online applications via MEDCAST, having a consultant or Project Leader is essential to ensure successful market authorization. Because we maintain a local office in Selangor, Rocky Consulting can not only assist with your registration but also serve as you as the LAR if required or your representative to interact with the Medical Device Authority on your behalf.

  • Our presence in Selangor allows us to efficiently interact with regulators on your behalf
  • We are fully capable of acting as the LAR if you have no other options to propose to your principal

There are three main stages for medical device registration which are outlined below.

Stage One: Pre-Market – the manufacturer is responsible for:

Stage Two: Placement on Market

  • Manufacturers or local authorised representatives (LARs) of manufacturers apply to register medical devices and establishment licenses.
  • Importers and distributors are required to apply for an establishment license to import/distribute medical devices. Both must also ensure compliance to Good Distribution Practice & advertising requirements.

Stage Three: Post Market

  • Establishments are required to monitor safety and performance of products and also carry out other post-market obligations like handling complaints, recalls and the GHTF recommendations – Medical Devices Post Market Surveillance: Content of Field Safety Notices.
  • Users of medical devices are expected to use, maintain and dispose medical devices appropriately.

Users of certain designated medical devices will need to apply for a permit to use & operate these products.