registration in Malaysia
Since the implementation of Act 737 (Medical Device Act 2012), it is a regulatory requirement to register all medical devices with the Malaysian Medical Device Authority (MDA). Registration with MDA can be done electronically through the web-based Medical Device Centralized Application System (MeDCASt).
For foreign manufacturer to commercialize medical device products in Malaysia, they must have a local authorized representative (a locally registered business entity) to register its medical devices with MDA. Unregistered medical devices can be imported, with special authorization or medical device exemption approval from MDA irrespective of the import purposes (e.g. clinical research, non-clinical use, exhibition and demonstration).
InnoSignum can support the registration of your medical device to into Malaysia. Working affiliated companies, which are fully capable of acting as your Malaysian Authorized Representative, Working with affiliated companies, which are fully capable of acting as your Malaysian Authorized Representative, Importer and/or Distributor, we can assist you from registration to commercialization of your products in Malaysia.
Our team is experienced with broad background in clinical trials management of phase II/III/IV trials, registry, and various therapeutic areas. With our combined experience of more than 20 years in clinical research, we understand the importance of cost and time as well as the technical quality of the result, and compliance with regulatory requirements.
Focusing on clinical research for medical device, biotechnology and pharmaceutical products, InnoSignum can provide one-stop services on protocol development and clinical study documents (i.e. Case report from (CRF) design, informed consent, etc.), clinical study start-up (i.e. Feasibility studies, organizing Investigator Meeting, Regulatory and Ethics Committee submissions), clinical study monitoring and project management, medical writing, clinical data management and biostatistics analysis.