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 dateChanges after registration in Pakistan
Source-linked rules for common changes to a registered medical device. Read the scope and conditions with each rule; unverified details are listed separately.
Does changing a device brand name or logo require an update?
A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.
A source-verified answer for this specific scenario is not yet published.
How do I update a manufacturer's name without changing the legal entity?
The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.
A source-verified answer for this specific scenario is not yet published.
What changes when the manufacturer's office address changes?
An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.
A source-verified answer for this specific scenario is not yet published.
Does a catalogue or reference code change affect registration or UDI?
Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.
A source-verified answer for this specific scenario is not yet published.
Can a registration transfer to a different legal entity?
A real change of legal manufacturer, registration holder or owner. This differs from renaming the same entity; a change of local representative or importer alone does not establish a registration transfer route. Where other changes occur with the transfer, the exact combination and sequence need separate evidence.
A source-verified answer for this specific scenario is not yet published.
Can several changes be filed together?
Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.
A source-verified answer for this specific scenario is not yet published.
What 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.
Continue from regulations into practical research
Keep Pakistan as the target market while you move into registration records, classification, cross-country product research, or pathway planning.
Classify a device for Pakistan
Check a preliminary DRAP risk class.
Search registered products
Inspect public DRAP records.
Compare products across markets
Search the same product in multiple country registries.
Build a registration plan
Estimate pathway, government fees, preparation, and review time.
Build a reusable product master
Structure company, product, model, approval, and evidence facts once.
Map dossier reuse and deltas
Compare existing evidence against Pakistan needs.
Build a market-launch workpaper
Connect route, evidence, labels, representatives, and launch dependencies.
Assess a regulatory change
Test a current DRAP update against one product and its evidence.