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.
Our fixed fee, with the fees you pay direct to the CAB and MDA shown separately — no hidden costs
Last updated: 18 September 2026
Since 28 January 2026, Circular Letter of Medical Device Authority No. 1/2026 requires every tenderer to hold a valid MDA establishment licence before participating in any new medical device tender — non-compliance is an offence under Section 15 of Act 737. Transitional exemptions cover only tenders awarded, letters of acceptance received or tender advertisements issued before 28 January 2026, and only until the existing contract or tender activity ends.
Verified against the official MDA portal: 10 August 2026 · WhatsApp us to start before the next tender cycle
GDPMD certification and the establishment licence are what this page covers. If you are a foreign manufacturer, there is a separate question first: who holds your device registration in Malaysia. You cannot register a device directly from overseas — a Malaysian authorised representative must hold it, and that choice binds you commercially, because the registration stays with the holder. Our ISO 13485 practice covers the AR, importer and distributor roles in full: who can hold your device registration, and what each route costs in the published MDA registration fees list.
AA Alive Sdn Bhd holds MDA establishment licence MDA-6798-K124 and acts as authorised representative for overseas manufacturers · WhatsApp us about AR scope
The establishment licence lets your company import, distribute or represent medical devices. It does not register the devices themselves: under Act 737, every product must also be registered with MDA, and only a licensed establishment can hold that registration. The device side starts with the class (A to D), set by the rules in this medical device classification guide. The full sequence is in how to register a medical device in Malaysia, and our sister practice runs it end to end as an MDA medical device registration service. Running the licence and the device dossier in parallel is the main way to shorten the overall timeline.
Our fee, year 1 — focused GDPMD certification support
Our fee, year 1 — GDPMD plus the MDA distributor licence application
Our fee, year 1 — GDPMD plus the MDA importer or authorised representative licence application
Our fee is payable 50% to kick off and 50% upon approval / completion. Monthly installments from RM 1,500/month are also available. No interest charges. Pay as you progress through the licensing stages. The CAB and MDA fees are paid by you direct, not through us. Surveillance years 2–3: our fee RM 2,500 a year, plus RM 2,585 a year paid direct to the CAB. Year 4 re-certification repeats year 1.
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. We quote our own fee separately from the CAB audit and MDA licence fees you pay direct, so you'll know exactly what you're paying, and to whom, 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.
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 |
|
|
GDPMD + Importer or AR Licence (our fee RM 5,500; CAB and MDA fees paid direct) |
| Distributor |
|
|
GDPMD + Distributor Licence (our fee RM 5,500; CAB RM 4,785 and MDA RM 2,250 paid direct) |
| Authorized Representative |
|
|
GDPMD + Importer or AR Licence (our fee RM 5,500; CAB and MDA fees paid direct) |
| 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.
The cost has two parts: our fee, and the fees you pay direct to the certification body (CAB) and to MDA.
Our fee includes consultation, documentation preparation, and regulatory support, and is payable 50% to kick off and 50% upon approval / completion. 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. For the GDPMD and licence work, our fee is RM 5,500 in year 1; the CAB audit and the MDA authorised representative licence fee are paid by you direct.
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 fee for GDPMD and the licence application is RM 5,500 in year 1; each licence role carries its own MDA fee, paid by you direct to MDA.
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 every 3 years. The renewal process requires:
We offer renewal services to ensure continuous compliance and avoid operational disruptions. Our support includes surveillance audit preparation (our fee RM 2,500 a year, plus RM 2,585 a year paid direct to the CAB), 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.
Get started with a free consultation and custom roadmap for your licensing journey.