Medical device registration in Malaysia is regulated by Medical Device Authority (MDA) of the Ministry of Health Malaysia. MDA is responsible to implement and enforce the Medical Device Act 2012 and the Medical Device Regulation 2012. According to Medical Device Act 2012, the local manufacturer or the Authorized Representative appointed by the foreign manufacturer is required to register a medical device before importing, exporting or distributing it in the Malaysia market.
Below are the 5 steps to register a medical device in Malaysia:
Step 1: Determine whether a product is a Medical Device
Before proceeding with the medical device registration, the establishment shall first determine a product is a medical device regulated under Medical Device Act 2012. Under the Act, medical device is defined as 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.
Step 2: Appointment of Authorised Representative (AR) in Malaysia
If the medical device is manufactured in foreign country, the foreign manufacturer must appoint an AR to handle the registration processes of their devices. The AR will act as the foreign manufacturer’s local agent (license holder) during the registration process and after registration approval.
Step 3: Obtain Establishment License
Only companies which have an Establishment License can register a medical device in Malaysia. However, to apply for Establishment License as an Authorized Representative, Importer and/ or Distributor with MDA, the party must be certified with GDPMD by Conformity Assessment Body (CAB) recognized by MDA. GDPMD Certificate is to ensure the establishment has the ability to safeguard the quality, safety and performance of medical device during all aspects of medical device supply-chain until it reaches the end user of Point of Care. Application for establishment licence can be done electronically through the web-based Medical Device Centralised Online Application System (MeDC@St 2.0+). Such application must be submitted with the following documents:
- application fee;
- document or information as specified in forms to be determined by the MDA; and
- a certificate and a report of conformity assessment.
Step 4: Conformity Assessment by CAB
An independent Conformity Assessment Body (CAB) needs to be appointed to review the registration application dossier and then issue a Certificate of Conformity that is submitted to the MDA. Conformity assessment is a systematic examination of evidence generated and procedures undertaken by the manufacturer in accordance with the MDA requirements to determine that a medical device is safe and performs as intended by the manufacturer and, thus, confirms to the Essential Principles of Safety and Performance for Medical Devices.
For Class A medical device, the establishment can directly submit their registration application via MeDC@St 2.0+. Following the implementation of MDA Circular Letter No. 2/2014, Appendix 1 Revision 4 effective as of October 13, 2021, there is a simplified process for conformity assessment for class B, C, and D medical devices that have undergone conformity assessment and have received approval in nations recognised by the MDA, such as the USA, EU, Canada, Australia, UK, and Japan. Otherwise, a full evaluation has to be conducted by CAB which requires longer timeline.
Step 5: Medical Device Registration
The submission of medical device registration can be made via MeDC@St 2.0+. The following documents are required for registration with MDA:
- General Information on the Medical Device
- Information on Manufacturer of Medical Device
- Grouping of Medical Device
- Common Submission Dossier Template (CSDT)
- Post-Market Vigilance History
- Declaration of Conformity (DoC)
- Attestation for Medical Device Registration
- Instructions for use (IFU) and Label
- Manufacturer’s ISO 13485 Certificate
How Flexly Consulting Can Help?
- GDPMD Certificate – Our consultants can guide you to implement GDPMD and obtain GDPMD Certificate
- Medical Device Registration – We are fully capable to register your medical devices and interact with the MDA on your behalf.
