Regulatory Assessment
We begin with a detailed evaluation of your product against Malaysian Medical Device Authority (MDA) requirements.
- Device classification & regulatory pathway mapping
- Gap analysis vs MDA, CE, TGA, or FDA standards
- Market entry strategy aligned with speed and compliance
CSDT File Preparation
We align your product documentation to meet strict Malaysian regulatory standards.
- CSDT (Common Submission Dossier Template) preparation
- Clinical evidence, performance data & risk management
- Labelling, IFU and compliance validation
A/R Appointment
We act as your locally licensed Authorised Representative (A/R), a mandatory requirement for foreign manufacturers.
- Legal representation with MDA
- Regulatory communication & submission ownership
- Compliance accountability within Malaysia
MDA Registration Submission
We manage the full registration lifecycle with precision and speed.
- Submission via Conformity Assessment Bodies (CABs) and Medcast 2.0 MDA portal
- Query handling & regulator engagement
- Approval tracking and timeline optimisation
Importation & Distribution
We activate a fully compliant supply chain to ensure seamless market access.
- Licensed importer & distributor execution
- GDPMD-certified warehousing and logistics
- Nationwide distribution capability
Market Adoption & Scalability
We support real-world adoption, not just regulatory clearance.
- Go to market strategy & pricing positioning
- Access to procurement networks and healthcare providers
- Scalable expansion across Malaysia and Southeast Asia
Post Market Compliance
Regulatory responsibility doesn’t end at approval, it evolves.
- Vigilance reporting & adverse event monitoring
- Product performance tracking & field safety actions
- MDA audit readiness & compliance maintenance
- Licence renewals, updates & variation submissions