Secure your mandatory Medical Device Authority license with Malaysia's most trusted GDPMD consultant. Transparent pricing, expert guidance, and proven results.
Navigating the Medical Device Authority (MDA) requirements is the critical first step for any medical device business in Malaysia. Whether you are an importer, distributor, or authorized representative, securing your MDA establishment license is mandatory before you can legally market your products.
Without this license, your business cannot:
The licensing process involves rigorous compliance with Good Distribution Practice for Medical Devices (GDPMD) standards, extensive documentation, and facility audits. One misstep can result in costly delays or rejection.
Transparent, fixed-price bundles to ensure your business meets every regulatory hurdle without hidden costs
Focused GDPMD certification support
Complete turnkey solution for importers and distributors
Comprehensive AR solution for foreign manufacturers
Monthly installments from RM 1,500/month available. No interest charges. Pay as you progress through the licensing stages.
Don't risk application rejection. Our experts provide comprehensive support from initial assessment to final approval.
We conduct comprehensive pre-assessment site visits to ensure your facility meets GDPMD standards before the official CAB audit. Our gap analysis identifies and resolves compliance issues early, preventing costly re-audits.
The Common Submission Dossier Template (CSDT) is the backbone of your MDA application. We handle the complex Technical File preparation, ensuring every section meets MDA requirements and reduces query response times.
From the initial site audit to final MDA approval in the Medic@st system, our dedicated consultants guide you through every step. We handle MDA communications, respond to queries, and ensure timely submissions.
With a 98% success rate and over 1,000 medical devices registered, we have the experience and expertise to navigate Malaysia's complex regulatory landscape. Our consultants stay current with the latest MDA guidelines and policy changes.
No hidden fees or surprise charges. Our all-inclusive packages cover consultation, documentation, CAB fees, and MDA submission costs. You'll know exactly what you're paying for from day one.
Our streamlined processes and pre-submission quality checks significantly reduce approval times. Most clients receive their MDA establishment license within 3-6 months, faster than the industry average.
A proven 6-step process refined through 1000+ successful registrations
1-2 weeks
We begin with a comprehensive assessment of your business operations, facility, and current compliance status. Our consultants identify the appropriate license type (Importer, Distributor, or Authorized Representative) and create a customized roadmap for your application.
4-6 weeks
We develop your complete GDPMD quality management system, including all required Standard Operating Procedures (SOPs), work instructions, and documentation templates. This ensures your facility operates in full compliance with MDA requirements.
2-3 weeks
We conduct an internal mock audit to identify any remaining non-conformances and ensure your team is prepared for the official CAB audit. This includes staff training on audit protocols and GDPMD requirements.
2-3 weeks
The Conformity Assessment Body (CAB) conducts the official GDPMD audit of your facility. Our consultants attend the audit, support your team, and coordinate the resolution of any findings. Once approved, you receive your GDPMD certificate.
6-8 weeks
With your GDPMD certificate in hand, we prepare and submit your complete MDA establishment license application through the Medic@st portal. We handle all documentation, fee payments, and respond to any MDA queries on your behalf.
1-2 weeks + ongoing
Once the MDA approves your application, you receive your establishment license. We provide guidance on maintaining compliance, preparing for annual renewals, and leveraging your license for product registrations.
Choose the right license category for your business operations
| License Type | Business Activities | Key Requirements | Recommended Package |
|---|---|---|---|
| Importer |
|
|
Importer & Distributor Package (RM 18,000) |
| Distributor |
|
|
Importer & Distributor Package (RM 18,000) |
| Authorized Representative |
|
|
Authorized Representative Package (RM 25,000) |
| Manufacturer |
|
|
Custom Manufacturing Package (Contact us for pricing) |
Note: Many businesses require multiple license types. For example, an importer that also distributes will need both capabilities listed under a single license. Our consultants will help determine the optimal licensing structure for your business model.
Understanding the relationship between these two critical certifications
Good Distribution Practice for Medical Devices (GDPMD) is specifically designed for companies involved in the storage, distribution, and importation of medical devices.
ISO 13485 is an international standard for quality management systems specific to medical device manufacturing and design organizations.
Required: GDPMD Certification
Not Required: ISO 13485
View Distributor PackagesRequired: ISO 13485
Also Required: GDPMD (if also distributing)
Contact for ISO 13485Required: GDPMD Certification
Manufacturer Must Have: ISO 13485
View AR PackagesExpert answers to common questions about MDA establishment licenses and GDPMD certification
An MDA establishment license is mandatory authorization from the Medical Device Authority (MDA) Malaysia for any business involved in importing, distributing, or manufacturing medical devices. Without this license, you cannot legally operate in Malaysia's medical device sector. The license ensures your facility meets Good Distribution Practice for Medical Devices (GDPMD) standards.
MDA establishment license costs vary by business type:
All packages include consultation, documentation preparation, and regulatory support. We also offer flexible monthly payment plans starting from RM 1,500/month with no interest charges.
The typical timeline is 3-6 months depending on your facility readiness and documentation completeness. Our process includes:
We expedite the process through proper preparation and pre-submission reviews to minimize delays from MDA queries or re-audits.
GDPMD (Good Distribution Practice for Medical Devices) is a mandatory quality management system for medical device distributors and importers in Malaysia. It ensures proper storage, handling, and distribution of medical devices to maintain product integrity and patient safety.
GDPMD certification from an MDA-approved Conformity Assessment Body (CAB) is required before applying for an MDA establishment license. The certification process involves developing SOPs, implementing quality systems, and passing a facility audit.
No, ISO 13485 is not mandatory for distributors and importers applying for an MDA establishment license. Distributors and importers need GDPMD certification instead.
However, manufacturers must have ISO 13485 certification. If you plan to manufacture medical devices in Malaysia, ISO 13485 certification is required in addition to GDPMD and the MDA establishment license. We provide both ISO 13485 and GDPMD consulting services.
Required documents include:
Our consultants guide you through complete documentation requirements and ensure everything is properly prepared before submission to avoid delays.
Foreign manufacturers cannot directly hold an MDA establishment license. They must appoint a Malaysian-based Authorized Representative (AR) who holds the license on their behalf.
The AR must:
We offer complete AR services including license application, GDPMD certification, and ongoing regulatory compliance support through our Authorized Representative Package (RM 25,000).
Importer license: For companies bringing medical devices into Malaysia from foreign manufacturers. Covers customs clearance and first-level distribution.
Distributor license: For companies distributing medical devices within Malaysia (may include locally manufactured or already imported devices). Covers storage, handling, and supply to end users.
Many companies hold both capabilities under a single license. The licensing process and GDPMD requirements are similar for both, with the main difference being the scope of operations declared in your MDA application. Our Importer & Distributor Package (RM 18,000) covers both.
With our 98% success rate and thorough pre-submission reviews, rejections are extremely rare. If MDA requests additional information or clarification (which is more common than outright rejection), we handle all communications and provide the necessary documentation.
We prevent rejections by:
Our experience with 1,000+ registered devices means we understand exactly what MDA requires and ensure compliance from the start.
Yes, MDA establishment licenses must be renewed annually. The renewal process requires:
We offer renewal services to ensure continuous compliance and avoid operational disruptions. Our annual renewal support includes surveillance audit preparation, documentation updates, and MDA submission management.
Yes, every company holding an MDA establishment license must designate a Qualified Person (QP). The QP is responsible for:
QP Requirements:
We provide QP training as part of our packages and can help you identify suitable candidates within your organization or recommend qualified professionals.
No, you cannot legally import, distribute, or sell medical devices in Malaysia without an approved MDA establishment license. Operating without a license can result in:
This is why it's crucial to start the licensing process before committing to inventory purchases or customer contracts. We recommend allowing 3-6 months for the complete process. Our expedited service helps you get to market as quickly as possible while maintaining full compliance.
Join 50+ successful companies who trust us with their regulatory compliance. Get started with a free consultation and custom roadmap for your licensing journey.