Can I read Guidelines for Combination Products in Malaysia on EtoBox?

Guidelines for Combination Products in Malaysia by Sales Team FBIO is a document available to read on EtoBox.

What is Guidelines for Combination Products in Malaysia about?

This guideline outlines the regulatory framework for drug-medical device and medical device-drug combination products in Malaysia, detailing the application process for endorsement letters, post-approval changes, and adverse reaction reporting. It specifies the roles of the National Pharmaceutical Regulatory Agency (NPRA) and the Medical Device Authority (MDA) based on the primary mode of action of the products. The document also includes definitions, registration processes, and requirements for dossier sub

Author

Sales Team FBIO

Language

EN