REGULATED BY THE MEDICAL DEVICE AUTHORITY (MALAYSIA) LICENSE NO. MDA-5880-W124
REGULATED BY THE MEDICAL DEVICE AUTHORITY (MALAYSIA) LICENSE NO. MDA-5880-W124

We will meet to review product portfolio, regulatory landscape and market entry requirements

We will be your Authorised, Licensed and Regulated Representative in Malaysia. Providing access to market and regulatory oversight

We will advise documentation requirements for registration including CSDT dossier preparation, supported by manufacturing evidence and certification. Submission will be completed and monitored all the way until approval.

We will manage your regulatory correspondence, renewals and vigilance reporting

We will assist in identifying MDA-Licensed distributors and product importers to aid with your transport logistics

We will provide insight into specific government and private sector product requirements to aid in your R&D resource allocation and to ensure you are best placed for product supply optimisation.
We use cookies to analyze website traffic and optimize your website experience. By accepting our use of cookies, your data will be aggregated with all other user data.