We bring your products to market.
01.
Independent Authorized Representative
Malaysia’s law mandated that a foreign manufacturer shall appoint a local authorized representative representing them in Malaysia. Global Rep offers independent authorized representative services. Use Global Rep to avoid unnecessary conflicts of interest in the supply chain that constrain your marketing efforts. Do you prefer to have full control?
02.
Establishment & device registration
Establishment intended to manufacture, important and/or distribute medical devices shall apply to the MDA the establishment license to play the role. The local manufacturer and the Authorized Representative of the foreign manufacturer shall then register the medical devices to be marketed in Malaysia. Isn’t it a big hassle? Leave all the hassles to Global Rep!
03.
Importer & distributor appointment
You need importers & distributors to market your devices in Malaysia. As an independent authorized representative, we appoint importers & distributors according to your instructions. We may link you up with companies that are keen to distribute your medical devices.
04.
Consultation
ISO13485 quality management system (QMS) and Good Distribution Practice for Medical Devices (GDPMD) are pre-requisites for obtaining an establishment license for the establishment to play the role as a manufacturer, importer, and distributor in Malaysia. Global Rep offers training and consultation services on regulatory affairs, QMS and GDPMD setup and maintenance.
We offer solutions for your success
Independent Authorized Representative
Establishment & medical device registration
Importer & distributor appointment
Consultation for Regulatory Affairs
We are here to help
Talk to our experts today. We tailor our services around your needs so that we can reach the desired outcome together.