- Management System
- Medical
- Malaysian Standard
GDPMD consultant in Malaysia for GDPMD certification
GDPMD certification is mandatory for medical device importers and distributors in Malaysia. Meet MDA licensing with expert consultancy and documentation.
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Standard overview
About GDPMD
It applies to all companies carrying out activities, as stated in the Medical Device Act 2012 (Act 737). It specifies the requirements for a quality management system to be established and maintained by an establishment.
Business value
Key benefits
- Mandatory for medical device establishment license (MDA).
- Ensure quality and integrity of medical devices.
- Manage recalls and complaints effectively.
- Traceability throughout the supply chain.
Who needs this?
Importers, distributors, and authorized representatives of medical devices in Malaysia.
Certification, training and compliance requirements vary by tender, buyer and regulator. We confirm what applies to you during the free consultation.
How we support you
A clear path from questions to readiness
Assess your starting point
Gap analysis against the requirements, scope confirmed and a realistic roadmap agreed.
Build the required system
Documentation, processes and records developed around how your organisation actually works.
Prepare your team
Role-based training, internal audits and corrective action so evidence is complete.
Prepare for review
Management review and support through the certification body’s audit.
How we work with you
The right consultant for your GDPMD project
We match every project to an experienced consultant who knows your industry, and the same consultant stays with you until you’re certified.
- Matched to your industryWe pair you with a consultant who understands your industry and the standard you’re working towards.
- Experienced with the standardYour consultant knows the requirements in detail and what auditors look for, and prepares your team for the certification audit.
- One consultant, start to finishThe same person handles your gap analysis, documentation, internal audit and certification audit.
“DR ISO audit was a great experience. The audit team was professional, supportive, and highly skilled. Their structured approach, clear explanations, and constructive recommendations helped us validate our processes and identify meaningful opportunities for improvement”
Common questions
Before you enquire
How long does GDPMD take?
It depends on your organisation’s size, scope and current readiness. After the gap analysis we give you a realistic timeline for your situation.
What support is included for GDPMD?
For GDPMD, the main focus areas are storage and transport controls, medical-device traceability, supplier and distributor controls, complaints and incident handling and recall procedures and distribution records. Support is tailored to where you are now and can include a gap analysis, documentation, implementation, staff training, internal audits and preparation for the certification audit.
Is GDPMD HRD Corp claimable?
DR ISO Malaysia is an HRD Corp registered training provider, so the training in your project can be claimable for eligible employers. We confirm the programme details and supporting documents during your consultation.
Does GDPMD include a money-back guarantee?
Yes. The conditions are explained to you before you start and written into the agreement you sign, so you know exactly what is covered.
Get clear guidance on your GDPMD scope.
Book a free consultation or WhatsApp us. We reply within 24 hours.