Our team are able to support registration of your medical device with the Malaysian regulatory authorities as we have consulted and involved in more than 100 medical device registrations in 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.