Thesis Medical Sdn Bhd
We are based in Klang Valley, Malaysia and specialized in Local Authorized Representative services (LAR) and Product Registration advisory services to manufacturer worldwide. We have been active in providing medical device management system and medical device regulations related consultancy services for more than 10 years.
We provide a comprehensive support to our clients from developing medical device management system until completion of the product registration process with Medical Device Authority (MDA) Malaysia.
Principal Partner Message
We can Act as your primary regulatory contact with the Medical Device authority (MDA) from registration to post-market services. We will help you submit all necessary medical device registration documents to the Conformity Assessment Body (CAB), MDA and assist with any follow-up questions. We will help you add your distributors allowed to import products.
In short, our services include Liaison with the local government agency on all regulatory issues. This include monitoring for any changes or new regulation applicable to your product and license holdings. Amendment and notification changes, adverse event reporting and management, products alert and recall tracking.