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.

Featured by Clinical Research Management (CRM)

CRM Bulletin (Issue 10) Knowing Clinical Trial 101:

“Zooming in on Homegrown CROs”

Our Services

Medical Device Registration

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.


It all begins with an idea. 

Budget Impact 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.

Clinical Research Management

Our team is experienced with broad background in clinical trials management of phase II/III/IV trials, registry, and various therapeutic areas. 

InnoSignum can provide one-stop services on protocol development and clinical study documents


Co-sourcing Services for Regulatory Services









QMS Consultation for GDPMD and ISO13485