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Understanding the Regulatory Landscape: Clinical Investigation of Medical Devices in Malaysia

Submission for clinical investigation of medical devices in Malaysia involves a structured process that adheres to regulatory requirements and international standards, including compliance with ISO 14155. This process begins with the preparation of comprehensive documentation, including the clinical investigation plan, investigator's brochure, informed consent form, and study protocol, all of which must comply with ISO 14155 guidelines. Additionally, documentation such as the investigator's curriculum vitae, ethical approval from relevant Institutional Review Boards (IRBs), and any applicable licenses or permits must be prepared. Once the documentation is complete and meets the regulatory and ISO standards, it is submitted to the Malaysian Medical Device Authority (MDA) for review and approval. MDA evaluates the submission to ensure that the proposed clinical investigation meets ethical and safety standards, aligns with applicable regulations, and contributes to the advancement of medical knowledge and patient care. Compliance with ISO 14155 ensures that the clinical investigation is conducted in a manner that upholds the highest standards of quality, safety, and data integrity throughout the process. 


Our team understands the intricacies involved and is well-versed in regulatory requirements, including ISO 14155 compliance. We offer comprehensive support throughout the documentation preparation and submission process, allowing you to focus on advancing your medical device innovations with confidence.

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