Our Services
Regulatory Notifications
We will thoroughly review your business plan and design a tailored approach that enables you to make non‑registered medical devices available in alignment with your business objectives, while ensuring strict compliance with all regulatory requirements. To achieve this, we will formally notify the relevant authority of your plan, prepare and submit the required documentation on your behalf, and secure the necessary approval. This proactive strategy not only safeguards regulatory compliance but also minimizes potential risks, giving you the confidence to move forward with clarity and certainty.
We are not ordinary
We are experienced in regulatory notifications, managing special access needs with expertise. At Global Rep, we ensure compliance and handle complexities with precision—so you can focus on your core business.
Popular Questions
No. However, a special access notification is required.
The special access notification shall be submitted to the Medical Device Authority at least 14 days before importing or supplying the medical 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.