About BioD Medica
BioD Medica, established in October 2015, is a company that specializes in regulatory affairs, clinical research and commercialization of medical devices in Malaysia and Singapore.
We can assist you from registration, and research to commercialization of your products in Malaysia and Singapore.
- Timely delivery of results at competitive pricing, as well as achieving the technical quality of the result, and compliance with regulatory requirements.
- We aspire to be a leading commercial and regulatory service provider and contribute to the development medical devices and increase medical related foreign direct investment in Malaysia and Southeast Asia.
Our Core Competencies
- Dynamic and Quality-Focused Team: Convergence between commercialization, regulatory compliance and clinical research
- Flat Organization: Empowering personnel to take charge and the management adopting a hands-on approach
- Lean & Flexible: Capable to tailor customized services as required by customers
To commercialize or conduct clinical trials of medical device products in Malaysia requires dealing with regulatory authorities to accessibility to hospitals/market access
01 | Medical Device Authority & Ministry of Health
02 | Local and Central Ethics Committees
03 | Professional Medical Societies and Associations
04 | > 100 registered account with hospitals / medical centres
05 | Partnership with universities & clinical research centre
We provide services focusing on medical devices, from product registration to distribution of medical devices:
- Medical Devices Registration
- Distribution or Commercialisation of Products
- Importation and Warehousing of Products
- Clinical Research Management
- Co-sourcing Services for Regulatory Services
- QMS Consultation for GDPMD and ISO13485
We are GDPMD Certified to:
A One-Stop Solution