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Malaysia Medical Device Regulatory Notifications
Malaysia medical device regulations maintain comprehensive and strictly enforced requirements to safeguard product safety, ensure performance, and uphold compliance standards. At the same time, these regulations provide flexibility to accommodate special circumstances. These may include clinical evaluations, training, demonstrations, and patient-specific custom devices, subject to the appropriate regulatory approval.
With in-depth knowledge of International and local Malaysia medical device regulations, we conduct a thorough review of your business plan and design a tailored regulatory strategy aligned with your objectives. Our approach enables you to introduce non-registered medical devices to the market while ensuring full compliance with applicable regulations and authority requirements. To achieve this, we formally notify the relevant regulatory bodies of your planned activities, prepare and submit all necessary documentation, and manage the approval process on your behalf. This proactive strategy not only secures regulatory compliance but also reduces potential risks, giving you the confidence to advance with clarity and certainty.
We are not ordinary
We have extensive experience in managing special access notifications and custom-made device notifications, ensuring full regulatory compliance with Malaysia medical device regulations.
At Global Rep, we manage documentation, authority submissions, and compliance planning with precision and care. This helps businesses navigate regulatory processes efficiently while allowing you to focus on your core business operations.
Popular Questions
No, you do not need to register it with the Medical Device Authority if it is imported solely for promotional purposes and not intended for commercial distribution.
However, you shall notify Medical Device Authority Notify about the medical device and the purpose of importation through a special access notification to comply with the Malaysia Medical Device Act 2012. The Act empowers the Minister to exempt any person or medical device from certain provisions of the Act or its regulations. Such exemptions may be granted if deemed consistent with the objectives of the Act or in the interest of public health and safety.
The Medical Device Authority’s turn-around time per custom made medical device notification is 14 days upon submission of complete form and supporting documents. Medical Device Authority further mentioned that they will notify the applicant of its decision and issue a “No restriction letter/Certificate of Exemption for Custom made medical device” permitting the applicant to import and/or place the medical device in the Malaysian market. It is understood that the application should be submitted 14days before importing or supplying the custom made device.
Medical devices for the purpose of clinical research or performance evaluation, education, personal use, and import for re-export.
No. For custom made medical devices, you shall submit a custom made device notification.
The Medical Device Authority (MDA) processes custom‑made device notifications within 14 days of a complete submission. Approved applicants will receive an approval letter from MDA, allowing the import and supply of the custom‑made medical device in Malaysia. Applications should be submitted at least 14 days prior to importing or supplying the device.