Who we are
InnoSignum Sdn Bhd, established in October 2015, a company affiliated to BioD Medica which specializes in regulatory affairs and clinical research of medical devices in Malaysia. Working affiliated companies, which are fully capable of acting as your Malaysian Authorized Representative, Importer and/or Distributor, we can assist you from research, registration to commercialization of your products in Malaysia.
What we do
Our team consulted and involved in more than 50 medical device approvals with Medical Device Authority (MDA) of Malaysia. InnoSignum can support the registration of your medical device to into Malaysia.
Our team is experienced with broad background in clinical trials management of phase II/III/IV trials, registry, and various therapeutic areas. Focusing on clinical research for medical devices, 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.
Budget Impact Analysis (BIA) may be required as the Supporting Economic Evidence, under Section 4 of the submission dossier for the listing of medicines into the Malaysian Ministry of Health Medicines Formulary (MOHMF) or Formulari Ubat Kementerian Kesihatan Malaysia (FUKKM). Our service includes data sourcing, BIA model building and reporting (BIA report and BIA model) as required for FUKKM submission.