MDA Product Registration Services in Malaysia

MDA Product Registration Services

Medical Device Authority (MDA)

MDA is a statutory body under the Ministry of Health Malaysia. It was established under the Medical Device Authority Act 2012 (Act 738) to control and regulate the medical device industry and to enforce the laws under the Medical Device Act 2012 (Act 737). It requires all establishments that are involved in the manufacture and distribution of medical devices to have an establishment licence and to register their devices. All medical devices must be evaluated and approved by MDA prior to being placed on the Malaysian market. Each approved product must carry the product registration certificate number issued by MDA.

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 intended by the manufacturer to be used, alone or in combination, for human beings for the purpose of –

diagnosis, prevention, monitoring, treatment or alleviation of disease;
diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
investigation, replacement or modification, or support of the anatomy or of a physiological process;
support or sustaining life;
control of conception;
disinfection of medical device; or
providing information for medical or diagnostic purpose by means of in vitro examination of specimens derived from the human body.

which does not achieve its primary intended action in or on the human body by pharmacological, immunological, or metabolic means, but that may be assisted in its intended function by such means.

Source: MDA/GD/0006 March 2014 First Edition

How to Register a Medical Device ?

Registration of medical devices is done via MDA’s online portal Medc@st. Applications are prepared and submitted to MDA for evaluation and approval. Once approved, a registration certificate with a unique number is issued to the applicant. The registration is valid for 5 years.

Determine if your product is a medical device.
Determine its risk class.
Determine the grouping if relevant.
Collect all regulatory information.
Prepare a CSDT (Common Submission Dossier
Template) – not applicable to Class A device.
Appoint CAB (Conformity Assessment Body) to
conduct product conformity assessment – not applicable to Class A device.
Submit to MDA for approval.

How We Can Help

This is one of our most utilised services. We have registered thousands of items for clients; they include ophthalmic devices, hospital hardware, single use devices, reusable surgical instruments, anaesthetic and respiratory devices, dental devices, implants, electro-mechanical devices, in-vitro diagnostic devices (IVDs), rehabilitation devices and many others. We can also assist with product risk classification, advertising permit applications as well as preparation of technical documents such as the CSDT (Common Submission Dossier Template).

Malaysia Product Registration Service for Medical Device

Searching for a Professional Medical Device Consultant?

Let our knowledgeable team of consultants assist you with registering your products so they may be quickly brought to market.