Our Services
System & Regulatory Compliance
In Malaysia, establishments manufacturing, importing, or distributing medical devices must first be certified with GDPMD or ISO 13485, as appropriate, before applying for the required MDA licenses. Once licensed, the local manufacturers or authorized representatives must register products with the MDA before they can be marketed. Why hassle? Global Rep manages licensing and registration, ensuring compliance while you focus on growing your business.
Our Core Responsibilities and Deliverables
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System Certification
Malaysian regulations require manufacturers to be certified with ISO 13485, while authorized representatives, importers, and distributors must comply with GDPMD. Global Rep helps you achieve compliance by designing practical systems, providing training, appointing certification bodies, and guiding audits—ensuring a robust framework while strengthening your team’s capabilities.
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Establishment Licensing
Once system certification is complete, we apply for establishment licenses with the MDA. Upon approval, your firm receives the appropriate license—ensuring full compliance and legal authorization to operate in Malaysia’s medical device market.
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Product Registration
Product registration in Malaysia is complex. We assess product risk classification, determine the conformity assessment route, review technical documentation, and resolve discrepancies before submission. For Class B–D devices, we recommend a suitable CAB and work closely with manufacturers to meet requirements. Once certification is obtained, we submit and monitor the registration with the MDA until approval—ensuring a thorough, efficient, and compliant process.
Why Global Rep Is Your Strategic Advantage?
The path to medical device market approval is complex and high-stakes, where missteps can cause costly delays. We expertly manage the entire process—from system setup to product registration—on your behalf. Entrust the compliance to us, so you can focus on growing your business without setbacks.
Popular Questions
Compliance requirements in Malaysia's medical device industry vary by role. Manufacturers must secure ISO 13485 certification and an establishment license, while contract manufacturers may need the certification if required by their clients.
No, Malaysian law does not recognize "sub-distributors." All distributors must be directly appointed by the local manufacturer or the foreign manufacturer's authorized representative.
No. A distributor’s license does not permit importation. To import devices into Malaysia, your company must obtain a separate MDA Importer’s license.
No. Establishment licensing approves companies to operate in the medical device sector, while product registration approves devices to ensure safety, quality, and performance. Manufacturers must demonstrate compliance, with claims reviewed by a Conformity Assessment Body and the Medical Device Authority before premarket approval.
Before a foreign medical device manufacturer can market its products in Malaysia, it must appoint a local authorized representative. The authorized representative is responsible for registering the manufacturer’s products with the Medical Device Authority before the products can be marketed in Malaysia.
Yes, product registrations can be transferred to Global Rep. We manage the full transfer process to ensure a compliant and seamless transition.
Marketing unregistered medical devices in Malaysia is a serious criminal offense under the Medical Device Act 2012. Establishments found guilty may face severe penalties, including fines up to RM200,000 and imprisonment for up to 3 years.