Pakistan medical device regulations
Official sources linkedDRAP rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.
| Code | Regulation | Category | Effective | Provenance |
|---|---|---|---|---|
| Device Classification | 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. | Registration | 2022 | Official |
| Medical Devices Portal | Medical Devices Division - DRAP Portal Main portal for DRAP Medical Devices Division. Access to registration, establishment licensing, and regulatory information for manufacturers and importers. | General | 2022 | Official |
| Registration Guidelines | Medical Device Guidelines Collection Collection of DRAP guidelines for medical devices including Good Reliance Practices and appeal procedures. Downloadable PDF documents. | Registration | 2022 | Official |
| Medical Devices Rules 2017 (Original) | 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. | General | January 2018 | Official |
| Medical Devices Rules 2017 | 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. | General | September 2017 | Official |
| DRAP | 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. | General | 2017 | Official |
| Establishment License | Medical Device Establishment Licensing Requirements Establishment license requirements for medical device manufacturers and importers. Valid for 5 years. Includes application forms and checklists. | Registration | 2017 | Official |
| DRAP Act 2012 | 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. | General | 2012 | Official |
Exports carry source + retrieval dateWhat these codes are
Each row above represents one regulatory instrument. Its code is the authority’s identifier. A regulation page collects the metadata and official source; when readable HTML is available, article links can open and highlight the exact cited passage.
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