Resources

Guidelines & Circulars

Clinical Trials

Medical Device Studies

Notification of Exemption from Registration of Medical Devices for The Purpose of Clinical Research or Performance Evaluation

First-in-Human/ Phase I Studies

Stem cell Studies

Circular – Research on Stem Cell & Cell-based Therapies

Bioequivalence/ Bioavailability studies

Regulatory guidelines on Bioequivalence

Sales & Services Tax

Frequently Asked Questions

Other Guidelines

Malaysian Decentralised Clinical Trial (DCT) Guidance Document

Guideline for Herbal Medicine Research

A Guide to Conducting Clinical Trials in Malaysia

Malaysian Guidelines on the Use of Human Biological Samples for Research

Guide to BA/BE
Centres in Malaysia

Contract Research Organizations based in Malaysia

Relevant Links

CRM Clinical Trial Agreement System

Malaysia Medical Repository

Malaysia’s Registry Report

National Medical Research Register

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