MDA Malaysia Medical Device Registration
Malaysia, with a population exceeding 34 million, is a significant and growing medical device market in Southeast Asia. The country's healthcare sector expansion and government initiatives to promote medical tourism are key drivers for this growth. Under the Medical Device Act 2012 (737) in Malaysia, medical device registration is required for all medical devices manufactured, imported, or sold in the the country.
Complying with the Medical Device Authority (MDA)
Regulatory Authority
Malaysia's medical device regulator is the Medical Device Authority (MDA). Pure Global can assist with Malaysia medical device registration and act as your Authorized Representative, ensuring MDA approval to sell in the Malaysian market.
Classification
Understanding the risk-based classification system is critical for aligning with Malaysia's regulatory requirements. The classification dictates the complexity of the technical documentation and the necessity for a Conformity Assessment Body (CAB) review.
Key Requirements
To market in Malaysia, foreign manufacturers without a local entity must:
- Appoint a local Authorized Representative (AR) who is responsible for liaising with the MDA and managing regulatory submissions.
- Ensure the AR holds an establishment license and Good Distribution Practice for Medical Devices (GDPMD) certification.
- Undergo a CAB review of the technical documentation before submission to the MDA.
Tailored Support for Market Entry
Our expertise is designed to streamline your market entry into Malaysia:
Assistance with product classification and determination of the regulatory pathway.
Compilation of the technical dossier and coordination of the CAB review.
Acting as your Authorized Representative, managing the registration with the MDA and ensuring compliance with post-market regulations.
Frequently
Asked Questions
What is the regulatory authority for medical device registration in Malaysia?
The Medical Device Authority (MDA Malaysia) is the regulatory body responsible for the registration of medical devices in Malaysia. The regulatory framework is established by the Medical Device Act 2012 (Act 737).
How are medical devices classified in Malaysia?
Malaysia uses a risk-based classification system for medical devices. This classification, regulated by the Medical Device Authority, Ministry of Health Malaysia, determines the complexity of the required technical documentation and whether a Conformity Assessment Body (CAB) review is necessary.
Is it mandatory to register all medical devices in Malaysia?
Yes, according to the Medical Device Act 2012 (Act 737), all medical devices that are manufactured, imported, or sold in Malaysia must be registered with the MDA. This registration process includes adhering to the MDA classification system.
What are the requirements for foreign manufacturers without a local entity in Malaysia?
Foreign manufacturers must appoint a local Authorized Representative (AR) to handle regulatory submissions and liaise with the Medical Device Authority, Ministry of Health Malaysia. The AR must hold an establishment license and Good Distribution Practice for Medical Devices (GDPMD) certification. Additionally, the technical documentation must undergo a review by a Conformity Assessment Body (CAB) before submission to the MDA.
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Our team of experts and local representatives, supported by partnerships with hundreds of clinical labs and the extensive GRIP database for over 100 countries, accelerates product launches and ensures compliance across 28 countries.
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Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.