Expert Guidance for Medical Device Authority in Malaysia Registration
Required Documents for MDA Registration
To successfully register a medical device with the Medical Device Authority in Malaysia, the following key documents are required:
- Common Submission Dossier Template (CSDT)
- Letter of Authorization (LOA) (if applicable)
- Good Manufacturing Practice (GMP) or ISO 13485 certification
- Device Master File (DMF)
- Clinical Evidence or Performance Data
- Declaration of Conformity (DoC)
- Post-Market Surveillance (PMS) Plan
- Risk Analysis Report
- Labelling and Packaging Information
- Essential Principles Checklist
- Software Validation Report (if applicable)
- Electrical Safety and EMC Test Reports (for electronic devices)
How to Register Medical Device in Malaysia?
Initial Consultation & Classification
We evaluate your device, determine its classification (Class A, B, C, or D), and define the necessary documents for submission.
Document Collection & Dossier Preparation
Our team gathers all required technical files and compiles them into an MDA-compliant dossier.
Submission via MeDC@St
We submit your dossier via MDA’s official online system, ensuring accuracy and compliance.
Responding to MDA Queries
If additional information is requested, we provide prompt clarifications to prevent delays.
Approval or Further Action
Upon successful review, the MDA grants approval. If revisions are needed, we will guide you through corrective steps.
Who Benefits from Our Services?
We assist a broad range of businesses in the healthcare sector, including:
- Medical Device Manufacturers Global and regional players entering the Malaysian market
- Distributors & Importers Ensuring compliance for market entry
- Healthcare Startups Supporting innovative medical technologies
- Clinical & Diagnostic Equipment Providers Assisting hospitals and labs with regulatory approvals
- Contract Research & Development Firms Helping medical innovators meet MDA standards
From registering a Class B thermometer to launching a Class D implantable device, our team ensures a smooth and compliant regulatory process.
End-to-End Medical Device Registration Services
As the Malaysia medical device market size continues to grow, regulatory compliance becomes increasingly important for companies looking to enter and expand in this competitive sector. Our services include:
Preparation and Compilation of Regulatory Dossier
Our experts compile a fully MDA-compliant dossier, covering product specifications, clinical data, labeling, and manufacturing details to ensure all documentation meets regulatory standards, minimizing approval delays and rejections.
Direct Liaison with the Medical Device Authority in Malaysia
As your local regulatory partner, we communicate with MDA, respond to inquiries, provide real-time updates, and coordinate regulatory processes to ensure a seamless approval experience without unnecessary setbacks.
Manufacturer Guidance and Documentation Support
We work directly with manufacturers to clarify documentation requirements, assist with compiling technical files, and ensure all necessary regulatory information is accurate, complete, and compliant with Malaysian medical device standards.
Online Submission via MeDC@St
Our experts manage the entire MeDC@St process, including account setup, document validation, online submission, and regulatory tracking, ensuring compliance with Malaysia’s medical device registration requirements and reducing processing delays.
Strategic Classification and Grouping of Devices
We determine the correct MDA classification (Class A, B, C, or D) and strategically group devices to reduce administrative workload, lower submission costs, and expedite the approval timeline for faster market entry.
Proactive Submission to Reduce Time to Market
We prioritize early registration to help companies achieve faster market entry, benefit from fee discounts, and ensure timely product availability, maximizing opportunities in the expanding medical device industry.
Expert Handling of MDA Queries and Review Process
If MDA requests additional information, we provide quick, accurate responses, ensuring compliance, minimizing regulatory delays, and keeping your registration process on track for swift approval and product launch.
Why Choose Nyprax Pharma for MDA Registration?
Regulatory Expertise
Our in-depth knowledge of MDA regulations ensures accurate submissions, reducing approval delays.
Comprehensive Support
From device classification to post-market compliance, we manage the entire registration process
Faster Market Entry
We handle regulatory complexities efficiently, so your device reaches the market without unnecessary delays.
Cost-Effective Solutions
Our strategic approach optimizes submission and grouping, minimizing registration costs.
Tailored Services
Every device is different; we customize our services to fit your product’s classification and business objectives.
Request a Call Back Today
Ensure smooth registration with the Medical Device Authority in Malaysia with Nyprax Pharma. We handle submissions, compliance, and approvals, minimizing delays. Whether for a single device or multiple products, we’ve got you covered.
Frequently Asked Questions
How long does it take to register a medical device in Malaysia?
- Class A (lowest risk): Can take 3–6 months.
- Class B and C: Usually processed within 6–12 months.
- Class D (highest risk): Can take up to 18 months due to extensive clinical review.
What is the current Malaysia medical device market size?
It has been growing steadily, with an estimated market value exceeding USD 2 billion. Key drivers include:
- Rising demand for healthcare services and medical equipment.
- Strong government support for the medical technology sector.
- Growth in exports, with Malaysia being a major hub for medical device manufacturing.
Why is early submission of medical device dossiers important?
- Taking advantage of early bird discounts offered by regulatory authorities.
- Avoiding last-minute processing delays that could disrupt sales.
- Ensuring compliance before new regulatory changes take effect.
What are the penalties for non-compliance with Malaysia’s medical device regulations?
It can result in:
- Delays or rejection of registration applications.
- Fines and penalties imposed by the medical device authority in Malaysia.
- Product recalls or bans from the market.
- Legal consequences for selling unregistered medical devices.
How can you reduce the cost of medical device registration in Malaysia?
- Grouping devices with similar specifications to reduce the number of required submissions.
- Submitting dossiers before early bird deadlines to benefit from fee discounts.
- Ensuring error-free applications to avoid resubmission costs.
Can Nyprax Pharma assist with medical device re-registration?
What is the role of the Medical Device Authority in Malaysia?
- Approving the registration of medical devices in Malaysia.
- Ensuring compliance with the Medical Device Act 2012 (Act 737).
- Issuing licenses to medical device establishments, including manufacturers, importers, and distributors.
- Monitoring post-market activities and enforcing corrective actions when needed.
What types of medical devices does Nyprax Pharma register?
Does the medical device authority in Malaysia recognize international certifications?
How to register a medical device in Malaysia if my company is based overseas?
If you are a foreign manufacturer, you must appoint a local authorized representative to submit your application through MedCast. Nyprax Pharma provides full regulatory support, acting as your local representative and managing the entire registration process to ensure compliance with Malaysian regulations. Schedule a free consultation with us today!