Why GDPMD? Who needs GDPMD?

Distributors of medical devices are required to apply for Establishment License from Medical Device Authority (MDA) to carry out their importing, distribution or wholesale activities.

Accordance with Medical Device Regulations 2012, Manufacturers require ISO13485 Medical Devices Quality Management System certification whereas local Authorized Representative, Importer and Distributors, require Good Distribution Practice for Medical Devices (GDPMD) certification prior to applying for their Establishment License.

GDPMD is suitable to authorised Representative, importer, distributor and logistics providers of medical devices in Malaysia

Benefits of GDPMD

Meet regulatory and customer requirements.

Fulfilment of establishment licensing requirements.

Demonstrate ability for proper storage, handling, distribution and traceability.

Getting Certified Easier, Faster & Hassle

Skip the guesswork! Our ISO consultant analyzes your business, guiding you step-by-step to ISO certification and standing out from the competition!

Here’s what you’ll get at your 100% free consultation

• • A gap analysis where we identify the areas for meeting the ISO best practices.
• • A-Z roadmap and the steps you need to take for getting ISO-certified.
• • The fundamentals for making your business ISO-compliant

Clear Workflow

Step 1: Get GDPMD Certified

Step 1.1: Let consultant to help you guys setting up the docs and training first.

Step 1.2: Once ready, then we'll call in the external auditor to audit you guys.

Step 2: Establishment License (With MDA)

Decide your role as an Authorised Representative, Importer, Distributor

Step 3: Product License (With MDA)

Clarify if your product falls under Class A, B, C or D.

Step 4: Let's Rock The Market!

You can now start selling it!

Fee and Duration

Step 1: Get GDPMD Certified (estimated 2 months)

Step 1.1 (Consultation fee) : Project Kick Off

Step 1.2 (Audit fee) : It’s charged by another 3rd party independent audit firm.

Step 2: Establishment License (estimated 1 month)

Step 2.1 : We'll help you to apply for free

Step 2.2 (Establishment License fee) : You pay directly to MDA through their website

• a) Authorised Rep: RM4250
• b) Distributor: RM2250
• c) Importer: RM2250

Step 3: Product License

Step 3.1: Consultation Fee applies according to Product Classification

• 1. Class A: Estimated 1 month to get MDA approval
• 2. Class B: Estimated 3 months to get MDA approval
• 3. Class C: Estimated 6 months to get MDA approval
• 4. Class D: Estimated 7 months to get MDA approval

Step 3.2 (MDA Product License fee) : Charged by MDA
Class A: RM100

Application fee + License Fee
Class B: RM250 + RM1000 = RM1250
Class C: RM500 + RM2000 = RM2500
Class D: RM750 + RM3000 = RM3750