Malaysia Authorized Regulatory Representation for Medical Devices
ANSWERED ON THIS PAGE:
- What are the requirements for a Malaysia Authorized Representative?
- Can we appoint our Malaysian distributor as our representative?
- What should we consider when choosing a representative in Malaysia?
Medical device manufacturers without a registered and licensed office in Malaysia must select an in-country representative, called a Malaysia Authorized Representative (AR). Your Malaysian Authorized Representative serves as your liaison with Malaysia’s Medical Device Authority (MDA) and is responsible for submitting your medical device registration, so it is important to choose your representative carefully.
Malaysia Authorized Representative requirements
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.
As an independent representative with a presence in Malaysia, Emergo can act as your Malaysia Authorized Representative, which allows you to control your device approval.
Can your distributor serve as your Authorized Representative to the MDA in Malaysia?
Many medical device manufacturers consider appointing a distributor as their Malaysia Authorized Representative. But this can be risky. Distributors focus on sales and marketing, rather than new and changing regulatory issues. Your Malaysian Authorized Representative also controls your device approval, so changing representatives can be difficult.
Registrations cannot be transferred, so a change in AR requires re-registration. If your distributor is also your representative, it limits your freedom to make changes in your company’s best interest.
We recommend selecting an independent authorized representative that is committed to ensuring your firm stays ahead of regulatory requirements in Malaysia. Read more about the benefits of hiring an independent authorized representative.
Choose Emergo as your Malaysia Authorized Representative
With offices in Kuala Lumpur, Emergo has the expertise and resources to perform all duties required of your Authorized Representative. Our consultants are up to date on the latest Malaysian medical device regulations and will ensure that you experience a smooth and efficient registration process.
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 the MDA and device recalls
- If desired, we can use your Malaysia registration dossier to ease your entry into additional Southeast Asian medical device markets
Please contact us for more information about how we can act as your Malaysia Authorized Representative.
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.
Is possible to transfer our MDA registration to a different representative?
No. The Authorized Representative role can be transferred with cooperation of the relinquishing party, but registrations do not convey.