MEDICAL DEVICE REGULATION IN MALAYSIA
Malaysia is currently one of the main countries in ASEAN that imports most of the medical device for domestic use.
The Medical Device Authority (MDA) was formed in June 2012 and voluntary registration started in July 2013. Transition phase was also introduced for companies to register their medical device to MDA. About 18,000 product registration applications were received and with more than 70,000 medical devices registered.
On 1 July 2016, the transition period ended and the Medical Device Act 737 was fully implemented. Products are required to be approved by the MDA before it can be supplied in Malaysia.
Malaysia regulation framework is based on IMDRF (formerly known as GHTF) and therefore there are benchmarking route of applications that are available in Malaysia.
MEDICAL DEVICE REGISTRATION AND APPROVAL IN MALAYSIA
Medical device including IVD is classified into 4 classes, namely:
· Class A (low risk);
· Class B (low medium risk);
· Class C (high medium), and
· Class D (the highest risk).
All medical devices regardless of its risk classification (unless exempted from product registration), to import and supply (in Malaysia or re-export) must meet one of the following criteria:
Obtained Acknowledgement Letter;
Listed in Medical Device Register; or
Authorised via one of the Authorisation Routes.
In general, Class A, Class B, Class C, and Class D medical devices have to be registered with MDA before it can be supplied in the Malaysian market.
Product Grouping is also allowed in Malaysia either as Single, Family, System, Set, IVD Test Kit or IVD Cluster.
Product registration dossier must be prepared in accordance with ASEAN Common Submission Dossier Template (CSDT). In the application, ARQon will work with the manufacturer on the device classification, grouping and CSDT preparation.
In Malaysia, applications must be submitted online via MeDC@St (Medical Device Centralised Online Application System).
Local Entity with GDPMD or with ISO13485
The company must be a local entity, also known as a local authorised representative. ARQon can help submit the application but with authorization from the product owner.
The overseas manufacturer should appoint the local importer and distributor that has the establishment license with GDPMD. The local importer and distributor should obtain the GDPMD certification from the recognized certification bodies that are accredited by the MDA. ARQon has its own GDPMD certification so as to help the manufacturer.
For those who would like to set up a local company or a subsidiary company in Malaysia, ARQon can help to set up the GDPMD procedure for certification and also assist in the establishment license application.
The local manufacturer who is based in Malaysia, can submit the product registration to MDA and has Establishment License with ISO 13485 certification. ARQon can help to set up the ISO 13485 procedure for certification and assist in the establishment license application.
Conformity Assessment (Verification route or Full Evaluation route)
If a product has been evaluated and obtained market clearance in at least one of the GHTF founder member countries, a conformity assessment by verification is applicable.
Otherwise, the medical device must undergo the conformity assessment by full evaluation route of application.
The conformity assessment is conducted by a third party independent body known as Conformity Assessment Body (CAB), similar to the notified body concept in Europe. The CAB must a recognized certification body that is accredited by the MDA.
The Turn Around Time (TAT) for the Conformity Assessment and Product registration varies on the device class and type of evaluation.
ASEAN / Asia REP
Gaining product approval from local authority and market entry has been more and more challenging in the ASEAN market over the years with rapid increase in regulatory requirement and challenges encountered during the custom clearance.
Many companies have outsourced their regulatory to simply appointing Regulatory consultancy firm to handle all the challenging regulatory requirement and opens up more options for the companies in terms of license holding, ease of appointing various distributors and acting on behalf of the company to face the expectations from the local authorities. The choice of your local representative is equally important so it is important to understand what the service and network coming from your local representative.
ARQon is a certified ISO13485 company that has manufacturer’s license, importer license and wholesaler license in Singapore, comprise of diverse background technical experts, and vast network in the ASEAN region and globally.
Whether you are a local or foreign manufacturer, ARQon can assist to:
Be your local representative in the country.
Submit product registrations for all product classifications.
Set up the QMS & technical file for ISO13485, GDP and CE
Hold product license in the country.
Transfer product license to distributor (when manufacturer secure its preferred distributor in the country)
Appoint multiple importers and distributors.