Medical Devices

Last Updated on January 4, 2023

Following guidelines are intended to help the industry and other applicants to meet the regulatory requirements related to the Medical Devices.

1. Distribution of Medical Devices

Guidelines on Good Distribution Practices of Medical Devices
English ( 520 KB – PDF)

2. Reliance Mechanism

Reliance Mechanism in Regulatory processes, A DRAP’s approach on Good Reliance Practices
English ( 454 KB – PDF)

3. Appeals Against Regulatory Decisions

Guidelines for Filling an Appeal Against the Decisions of Statutory Bodies (e.g. Registration Board)
English ( 371 KB – PDF)