🇵🇰Pakistan Medical Device Regulations

Medical Device Guidelines Collection

Collection of DRAP guidelines for medical devices including Good Reliance Practices and appeal procedures. Downloadable PDF documents.

Medical Device Application Process

Step-by-step application process for medical device registration. Covers online submission via MDMC system, Form-2 hardcopy, and establishment license requirements.

Medical Devices Division - DRAP Portal

Main portal for DRAP Medical Devices Division. Access to registration, establishment licensing, and regulatory information for manufacturers and importers.

Medical Devices Rules 2017 - Original Notification (PDF)

Original notification of Medical Devices Rules 2017 as published January 16, 2018. Establishes GHTF-based classification and regulatory framework.

Medical Devices Rules 2017 (Updated April 2022) - Full Text PDF

Primary rules governing medical device regulation in Pakistan. Updated April 2022. Establishes risk-based classification, registration requirements, and establishment licensing.

Drug Regulatory Authority of Pakistan - Medical Devices Division

DRAP is the national regulatory authority for medical devices in Pakistan. Established under DRAP Act 2012. Responsible for device registration, establishment licensing, and vigilance.

Medical Device Establishment Licensing Requirements

Establishment license requirements for medical device manufacturers and importers. Valid for 5 years. Includes application forms and checklists.

Drug Regulatory Authority of Pakistan Act 2012

Foundational act establishing DRAP as the national regulatory authority. Provides legal framework for regulation of drugs, alternative medicines, medical devices, and cosmetics.