Medical Device & Pharmaceutical Registration
Medical Device & Pharmaceutical Registration
Navigating the registration process for medical devices and pharmaceutical products can be challenging. Our dedicated registration service ensures that your products meet the stringent requirements set by regulatory bodies, enabling timely market access.
Our Advantages
Efficient Registration Process
We manage every aspect of the registration journey—from product classification to documentation—ensuring a smooth, compliant, and timely approval process.
Diverse Expertise
Our experience spans multiple product types, including Class A-D devices, drug-device combinations, cosmetics, and OTC drugs, providing comprehensive support across your portfolio.
Strategic Documentation & Compliance
We meticulously prepare and review all required submissions, reducing the risk of delays and ensuring your products meet the stringent regulatory requirements.
Registration Process
1.
Step 1: Classification
IVD devices in Malaysia are classified into four classes based on risk level:
- Class A: Low Risk
- Class B: Low-Moderate Risk
- Class C: High-Moderate Risk
- Class D: High Risk
2.
Step 2: Submission
Once classified, devices in Classes B, C, and D must undergo a conformity assessment by a registered Conformity Assessment Body (CAB). If conformity is confirmed, the registration application is submitted through the Medical Device Centralized Online Application System (MeDC@St2.0+). The application must include comprehensive documentation as per the Common Submission Dossier Template (CSDT), except for Class A devices.
3.
Step 3: Evaluation
The Medical Device Authority (MDA) evaluates the application to ensure compliance with the Medical Device Act 2012 (Act 737) and that the device meets all safety and performance requirements.
4.
Step 4: Approval
Upon successful evaluation, the MDA grants approval, allowing the IVD device to be legally imported, exported, and marketed in Malaysia.
How We Can Support?
As a licensed local authorized representative, we serve as the essential bridge between international manufacturers and Malaysian regulatory authorities.
Classification & Documentation
We manage registration for devices classified under Class A, B, C, and D, ensuring that each product meets its specific regulatory criteria.
Drug-Device Registration
For products that combine both drug and device components, we provide comprehensive registration support.
Product Classification Applications
Our experts help determine the appropriate classification for your products, facilitating the right registration pathway.
Free Sale Certificate Applications
We assist in securing certificates that attest to the quality and compliance of your products for international trade.
Special Access
We handle submissions for special access or clinical research, enabling your products to enter the market under controlled conditions for further study or use.
Phone: +60193878020