- Home
- >
- Malaysia
- >
- Medtech
Medical Devices Regulatory Services in Malaysia
Your Partner for End-to-End Regulatory Affairs Services in Malaysia, From Strategy to Registration and Post Approval Maintenance
Artixio offers extensive regulatory services to global manufacturers, facilitating smooth navigation of Malaysia’s MDA regulations.
Medical Device Authority (MDA) regulates the import, manufacture, export and supply of medical devices in Malaysia to safeguard public health and safety.
Services
Regulatory Intelligence & Strategy
MDR Gap Assessment
Medical Device Regulatory Affairs
Quality Consulting
Technical and Medical Writing
Clinical, Performance Evaluation
Medical Device Registration / Certification
Authorized Agent / Legal Representation
Post Market Surveillance
Key Regulations for Medical Devices in Malaysia
Medical Device Act 2012 (Act 737)
Medical Device Authority Act 2012 (Act 738)
Classification of Medical devices
In Malaysia, devices are classified to Class A, B, C and D depending on their risk level. Class A devices have low risk to patients, Class B devices are low to moderate risk, Class C devices are moderate to high risk while Class D devices are high risk, complex devices.
Process for Registration of Medical Devices in Malaysia
Documents Required for Registration of Medical Devices in Malaysia
The documents required for medical device Malaysia are in accordance with CSDT, below are the elements
- Executive Summary
- Device Description
- Design Verification & Validation
- Clinical Evidence
- Device Labelling
- Risk Analysis
- Manufacturer Information
Artixio’s Medical Devices Registration Services in Malaysia
Our Regulatory and Market Access experts based in Malaysia, coupled with the Global Regulatory Projects team, have helped over a hundred pharmaceutical, medical devices, diagnostics, cosmetics, nutraceuticals, supplements, and veterinary products successfully register and maintain compliance in Malaysia. Combined with Artixio’s intelligence-based services platform, Dvarka, innovators and manufacturers from around the world have benefited by seamlessly managing the regulatory strategy across the product development and commercialization value chain.
For Medical Devices, from strategic planning and registration to post-market compliance, Artixio provides high-quality regulatory affairs services to support your business needs.
Why Artixio?
Industry Recognized (CPHI Pharma Awards 2024) Tech-Enabled, Regulatory Intelligence driven Services
Ensuring compliance for 200+ Devices and Diagnostics Products Licenses
120+ Countries supported
Inhouse Regulatory Experts with 15-30+ Years of Experience
End to End Support from Product Conceptualization to Launch and Post Market Support
Wide Product Experience: Devices, Diagnostics, Combination Drugs, Software as Medical Devices (SaMD), Consumer Devices
Diverse Experience across Complex Therapeutic areas and Application Areas
ISO 9001:2015, Quality Driven Services Platform
Flexible Business Models – Project Based; Long Term FTE based
Customer Focused, Nimble Team
KPI based, continual process excellence
Represent your organization and device in Malaysia
FAQs
If we have created MeDC@St account. Do we need to apply for establishment license, medical device registration or both?
All establishments, that is manufacturers, authorized representative (AR), importer and distributor must apply for establishment license. Yet only manufacturers and authorized representative (AR) need to apply for medical device registration.
How do we notify MDA in terms of changes (E.g. change manufacturing site from one country to another country etc.)?
At the moment, writing to MDA will help with additional necessary changes. If changes of certificate, the latest certificate must be submitted to MDA. Example changes of manufacturing sites for GDPMD/ISO 13485, certificate must be submitted to MDA together with the application for amendment.
Does the authorized representative (AR) require local staff working in the Malaysia office? If our office staff is handling everything from other countries, is this acceptable?
If the medical device is planned to place in Malaysia market, then it is subjected to Act in Malaysia. AR must be licensed and should live in Malaysia
How to apply for re-registration?
Re-registration can be applied through the MeDC@St application system. The re-registration button will be seen 1 year prior to expiry date. If the re-registration button does not appear within 1 year prior to expiry in the application system you can notify the helpdesk.
Does AR info and registration number need to be put on primary packaging or secondary or both
AR information and registration number shall be on the packaging where the information can be accessed at the point of receiving by the customers/users.
The Registration number and AR information should be on the packaging so the customers or users can access it when they receive the product.
Regulatory Expertise Across
Multiple Countries
India
Vietnam
Mexico
Vietnam
United States
Brazil
Europe
Malaysia
Taiwan
China
Thailand
Philippines
Blogs
In Vitro Diagnostics: Meaning,
The term “in vitro” is a Latin word that means “in glass”. Thus, from...
IVD Medical Devices Registration
The in vitro diagnostic in India is regulated by the Central Drugs Standard Control...
Pharma Manufacturing Booms in
Once overlooked pharma hub in Mexico's Hidalgo region has gained importance with global market...