Management System Consulting
Good Distribution Practice for Medical Devices
GDP-MD compliance for medical device distributors in Malaysia.
Responds within one business day
What we deliver
- GDP-MD gap assessment against MDA requirements
- Quality Management System documentation for distribution
- Temperature and cold chain management procedures
- Product recall and return procedure design
- Staff training on GDP-MD requirements and handling
- Mock MDA inspection preparation
- CAPA system for non-conformances
Overview
Good Distribution Practice for Medical Devices (GDP-MD) is a mandatory requirement for medical device distributors registered with the Medical Device Authority (MDA) in Malaysia. Non-compliance can result in licence cancellation and enforcement action.
MEDSS supports medical device distributors in building GDP-MD compliant quality systems, preparing for MDA inspections, and maintaining ongoing compliance as the regulatory landscape evolves.
What We Deliver
- GDP-MD gap assessment against MDA requirements
- Quality Management System documentation for distribution
- Temperature and cold chain management procedures
- Product recall and return procedure design
- Staff training on GDP-MD requirements and handling
- Mock MDA inspection preparation
- CAPA system for non-conformances
Key Benefits
Regulatory compliance
Maintain your MDA establishment licence and avoid enforcement actions.
Patient safety
Proper distribution controls ensure product integrity throughout the supply chain.
Audit readiness
Documented systems allow you to demonstrate compliance confidently during MDA inspections.
Who needs this service
Medical device importers, distributors, and wholesalers registered or applying for establishment licences with the Medical Device Authority Malaysia.
Ready to get started?
Interested in Good Distribution Practice for Medical Devices?
Contact MEDSS for a no-obligation consultation. Our consultants will assess your needs and propose the right solution.
- HRDC Claimable
- 200+ Organisations
- Responds in 1 day