Maven
MDR-in-Malaysia

Medical Devices Registration in Malaysia

Contact Us

Are You Looking For Medical Devices Certifications?

Get it here!

Looking for Regulatory Consultant ?

    Who is eligible to register a medical device in Malaysia?

    Only locally registered companies in Malaysia, recognized by the Companies Commission (SSM), are permitted to apply for an establishment license, proceed with medical device registration, and obtain export permits. Once registered with the SSM, companies can access MeDCASt2.0+ to initiate their application for an Establishment License, tailored to their specific activity: Manufacturer’s License, Importer’s License, Distributor’s License, or an Authorized Representative’s License. Having an Establishment License is a prerequisite for registering a medical device in Malaysia.

    Since only local companies can apply for an Establishment License, foreign manufacturers have several options to register their medical devices in Malaysia:

    • Establish a local subsidiary entity dedicated to registering the medical device.
    • Engage a local importer or distributor possessing a valid establishment license, Good Distribution Practice for Medical Devices (GDPMD) certification, and a Registrant Account in the Medcast system to handle the registration process.
    • Utilize an independent Authorized Representative like Maven for registering the medical devices. With a valid Medcast Registrant Account, Maven acts directly on behalf of foreign manufacturers, handling device registration and license maintenance. This setup offers flexibility in appointing importers or distributors without affecting the product license status amidst changes in the distribution network.

    Introducing Medcast (Medical Device Centralized Online Application System)

    Medcast, also known as the Medical Device Centralised Online Application System (MeDCASt), is an online platform managed by the Malaysian Medical Device Authority (MDA). It is the primary system for handling various applications related to Establishment Licensing, Medical Device Registration, and Export Permit.

    Parties involved in the medical device industry in Malaysia, including manufacturers, importers, exporters, distributors, and Authorized Representatives, are required to utilize Medcast for submitting applications, especially for medical device registration with the MDA.

    Originally launched in July 2013, Medcast underwent an upgrade to Medcast 2.0 in January 2019. As of February 1, 2022, MDA has introduced further enhancements with Medcast 2.0+ to improve the user experience and service quality.

    Medcast 2.0+ introduces new features such as the Change Notification Module, Device Study sub-module (under the Clinical Research module), Clinical Research Use sub-module (under the Clinical Research module), and Demonstration for Marketing Notification and Payment module. These additions reflect MDA’s commitment to continuous improvement in service delivery for stakeholders in the medical device industry.

    Medical device registration timeline and fees in Malaysia

    Registration Stage Timeline Fees (MYR)
    Submission of Application 2-4 weeks 500-2000
    Document Preparation 2-3 weeks 1000-3000
    Compliance Assessment 4-6 weeks 2000-5000
    Inspection (if required) 6-8 weeks 3000-7000
    Review and Approval 8-12 weeks 5000-10000
    Certificate Issuance 2-4 weeks 1000-2000
    Renewal Every 1-3 years 2000-5000
    Post-Market Surveillance Ongoing N/A

    *NOTE – Please note that the timelines and fees provided above are approximate and may vary depending on factors such as the complexity of the medical device and the responsiveness of the regulatory authority.

    Registration Process

    Registration-Process

    Registration Pathway

    Class Registration Pathway
    A (Low-Risk) MDA Application
    B (Low-Moderate) CAB Assessment followed by MDA Application
    C (Moderate-High) CAB Assessment followed by MDA Application
    D (High-Risk) CAB Assessment followed by MDA Application

    *Note – Conformity Assessment Body

    What is considered a medical device in Malaysia?

    In Malaysia, the term ‘medical device’ encompasses a wide range of products utilized in healthcare for diagnosis, prevention, monitoring, or treatment purposes, excluding drugs. This definition also includes in-vitro diagnostics (IVDs). To comply with regulatory standards outlined in Section 2 of Act 737 (refer to guidance document MDA/GD/0006), any medical device must undergo registration before importation, exportation, or placement in the market.

    Medical-Devices-Registration-in-Malaysia

    What documents are required to register medical devices in Malaysia?

    To register a medical device in Malaysia, several documents are required, all of which must be submitted in English. Primarily, a Common Submission Dossier Template (CSDT) must be completed. This comprehensive dossier encompasses an :

    • Executive Summary
    • Pre-Clinical Studies
    • Clinical Evaluation
    • Device Labeling
    • Instructions For Use
    • Risk Analysis
    • Proof Of Quality Management System
    • Manufacturing Information
    • Essential Principle Checklist
    • Declarations Of Conformity

    Additionally, existing regulatory approvals or market authorizations must be included.

    Certain products may necessitate supplementary documentation, particularly those involving radiation, derived from animal tissues, or featuring Bluetooth and wireless network functionalities.

    For Renewal of Registration, following documents are required :

    • LOC
    • Medical Device Information
    • Manufacturing Information (Process Flow Chart)
    • LOA
    • Labels
    • IFU
    • DoC
    • Pre-Clinical Studies
    • Other Validation Reports (Software/critical process if any)

    Validity of License

    When it comes to medical devices registration in Malaysia, a Certificate of Conformity from an authorized local conformity assessment body (CAB) is essential. Under the fast track system, devices that already have approval from reference countries can receive provisional registration. This allows up to 5 years to submit the locally issued Certificate of Conformity.

    Authorities Responsible for Medical Devices Registration in Malaysia

    In Malaysia, the process of medical devices registration is overseen by regulatory authorities to ensure compliance with established standards and regulations. Here are the key entities involved in the medical devices registration process:

    • Medical Device Authority (MDA): The MDA is the main regulatory body responsible for the registration and regulation of medical devices in Malaysia. It operates under the Ministry of Health and oversees the implementation of the Medical Device Act 2012 (Act 737) and its related regulations.
    • Centralized Evaluation Committee (CEC): The CEC is a committee appointed by the MDA to evaluate and assess the safety, efficacy, and quality of medical devices seeking registration in Malaysia. It reviews the technical documentation submitted by manufacturers and assesses compliance with regulatory requirements.
    • Notified Bodies (NBs): Notified Bodies are independent organizations designated by the MDA to assess the conformity of medical devices with relevant standards and regulations. They conduct audits and assessments of manufacturers’ quality management systems and assist in the certification process for medical devices.
    • Medical Device Registration Holder (MDRH): The MDRH is the entity responsible for submitting registration applications to the MDA on behalf of medical device manufacturers or importers. They ensure that all necessary documentation and information required for registration is accurate and complete.
    • Authorized Representatives (ARs): Authorized Representatives act on behalf of foreign manufacturers who do not have a presence in Malaysia. They facilitate communication with regulatory authorities and ensure compliance with local regulations for medical device registration.

    By collaborating with these regulatory authorities, manufacturers can navigate the medical device registration process in Malaysia effectively and ensure compliance with regulatory requirements, thereby gaining access to the Malaysian market for their medical devices.

    Our Blogs

    LATEST NEWS

    Blog Image

    July 18th, 2024

    Cybersecurity Uncovered: Understanding the Potential of CVSS-B

    Read More
    Blog Image

    July 11th, 2024

    Symbology For Safety: Unifying Medical Device Labels Across Cultures

    Read More
    Blog Image

    July 4th, 2024

    Strategic Sampling: Optimizing Your Data Collection Process

    Read More

    Connect With Us

      mail
      ×