The AR must be a citizen or permanent resident of Malaysia. The representative must also hold an Establishment License and a certificate of Good Distribution Practices, Medical Devices (GDPMD). Your medical device registration is submitted by the authorized representative, and the Conformity Assessment Body (CAB) certification is issued in the name of your representative.
for Medical Devices (AR)
- Liaison with the local authorized government agency on all regulatory issues relating to your medical device including amendment and change notifications
- Regulatory monitoring to alert you to any changes or new regulation applicable to your product
- License holding
- Adverse event reporting and management
- Product alert and recall tracking
- Complaint handling
We Also Offer
Additional Support Services
- Regulatory intelligence reports giving you insight into the best routes for market access and the latest on the regulatory landscape in your target market
- Online regulatory training
Here’s How We Can Help:
Act as your primary regulatory contact with the MDA, from registration to post-market activities
Submit all necessary medical device registration documents to the CAB and MDA and assist with any follow-up questions
Add distributors allowed to import products
Assist in adverse event reporting to MDA and device recalls
If desired, we can use your Malaysia registration dossier to ease your entry into additional Southeast Asian medical device markets
Malaysia Medical Device Authorized Representative
Medical Device manufacturer without local presence in Malaysia requires In country representative known as Medical Device authorized representative, who will be a liaison between manufacturer and the Medical Device Authority (MDA) for registration and submitting the application.
MeDC@St is a web-based Medical Device Centralised Online Application System for registration with the MDA, for Establishment Licensing, Medical Device Registration and Export Permit. It can only be done by a local Authorized Representative. The representative must have an establishment licence and a certificate of Good Distribution Practices, Medical Devices (GDPMD).
We are marketing multiple products in Malaysia. Can we appoint more than one authorized representative?
Yes. Manufacturers with multiple devices can appoint a different representative for each device. You may only appoint one representative per device.
Yes, registrations may be transferred to another AR with the agreement of your current AR.