Pakistan - Top Medical Device Alerts

Reliance Mechanism In Regulatory Processes "DRAP Approach on Good Reliance Practice". " This document aims to provide policy guidance to define criteria, procedures, and mechanisms for reliance pathways to facilitate regulatory decisions by giving significant weightage to the assessments performed by other National Regulatory Authorities or trusted institutions as a reference for various decision-making processes in regulatory functions performed by DRAP. "
SRO 224(I)/2023: Notification of Amendment. Notification of Amendment in the Medical Devices Rules, 2017, dated 27th February 2023.
Updates: Schedule of Charges; Regulatory Fees for Therapeutic Goods by Drug Regulatory Authority of Pakistan. The Drug Regulatory Authority of Pakistan (DRAP) issued a consolidated notification of Regulatory fees for various functions and services.
Guidance on Clinical Trails Applications. This document is intended to provide general guidance to applicants in making new applications for clinical trials on therapeutic goods or any subsequent submissions to the Drug Regulatory Authority of Pakistan (DRAP).
Imports & Exports of Therapeutic Goods. This document is applicable f for the import and export of therapeutic goods for commercial and non-commercial purposes.
How can RegDesk help?
RegDesk is a holistic Regulatory Information Management System that provides medical device and pharma companies with regulatory intelligence for over 120 markets worldwide. It can help you prepare and publish global applications, manage standards, run change assessments, and obtain real-time alerts on regulatory changes through a centralized platform. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Global expansion has never been this simple.