An Overview – Malaysia Medical Device Registration
Medical device registration in Malaysia is a crucial step for businesses that want to import or manufacture medical devices. Without necessary registrations and approvals, you cannot conduct your business operations in the country.
In this article, we will walk you through Malaysia’s regulatory framework, mandatory requirements for the MDA registration application, and the process.
Also read, Guide for Medical Device Regulations by Countries
Looking For a Medical Device Regulatory Consultant?
Malaysia offers one of Southeast Asia’s most robust and dynamic markets for foreign medical device manufacturers. To obtain market authorization in Malaysia, you must first register your product with the Malaysian Medical Device Authority (MDA). Registration with the MDA is done electronically through the web-based Medical Device Centralised Online Application System (MeDC@St) and can only be done by the local Authorized Representative.
The Medical Device Act 2012 (Act 737) in Malaysia is a significant legislative framework aimed at regulating medical devices to ensure their safety, effectiveness, and quality. It details the registration process for medical devices, regulatory bodies, and the requirements for manufacturing, distributing, and importing medical devices in Malaysia.
Classification of Medical Devices
Medical devices in Malaysia are classified into 4 risk classes:
Class A: Minimal risk (blood pressure cuffs, scissors, etc.)
Class B: Low to moderate risk
Class C: Moderate to high risk (moderate to high risk)
Class D: Highest risk (implantable devices/devices that significantly affect the physiology of the human body)
Correct classification of devices is the most important step in the regulatory strategy process, and it is especially important in Malaysia due to its rapidly evolving regulatory system. In mid-2016, the Malaysia MDA implemented a formal classification system.
Key Steps for Medical Device and IVD Registration
Classification: Devices are categorized into four risk classes (A to D) based on risk levels. Proper classification determines the registration pathway.
Authorized Representative (AR): Foreign manufacturers must appoint a local AR registered with the MDA to act as a liaison.
GDPMD Compliance: Distributors/importers must follow Good Distribution Practices for Medical Devices for proper handling and storage.
Technical File Preparation: Manufacturers need a detailed technical file covering design, manufacturing, risk analysis, and clinical evidence.
Online Submission: Applications are submitted via the MeDC@St platform, including the technical file and proof of compliance.
Review and Approval: MDA reviews the application and issues a five-year registration certificate upon approval.
Document Requirements for Registration in Malaysia
The medical device registration form requires the following components:
- General information on the medical device
- Information on manufacturer of medical device
- Grouping of medical devices
- Common Submission Dossier Template (CSDT)
- Post-market vigilance history
- Declaration of conformity
- Attestation for medical device registration
Challenges in Registration
- Understanding the complex regulatory framework.
- Ensuring proper documentation and compliance.
- Keeping up with updates to MDA guidelines and requirements.
Looking for Expert Guidance on Medical Device and IVD Registration in Malaysia?
Role of Operon Strategist
Operon Strategist is a leading medical device regulatory and manufacturing consulting company that provides end-to-end support for medical device and IVD registration in Malaysia. Here\u2019s how we can help:
- Device Classification Support: We assist manufacturers in accurately classifying their devices according to MDA guidelines.
- Technical File Preparation: Our experts ensure that your technical file meets all regulatory requirements, reducing the risk of delays or rejections.
- Authorized Representative Services: For foreign manufacturers, we help identify and manage relationships with local Authorized Representatives.
- Compliance with GDPMD: We guide distributors and importers in implementing Good Distribution Practices for Medical Devices.
- Regulatory Submission: The Operon Strategist manages the entire submission process through the MeDC@St platform, ensuring all documentation is accurate and complete.
- Post-Market Surveillance Support: We assist in setting up robust post-market surveillance systems to meet MDA requirements.
Operon Strategist’s comprehensive services cover end-to-end support for regulatory approvals such as European CE marking, FDA 510(k), Indian CDSCO manufacturing and import registration, SFDA, and UKCA compliance. Operon Strategist also assists in establishing manufacturing units by offering services like facility layout design, cleanroom design, machine validation, and ensuring facility compliance with regulatory standards. They prioritize quality through adherence to ISO 13485, FDA QSR, MDSAP, and other relevant approvals.
