Pakistan DRAP MDMC Online Portal: Medical Device Registration and Establishment Licensing Guide

Quick answer

Pakistan medical device registration through the DRAP portal is now handled exclusively online. On 21 July 2025, the Drug Regulatory Authority of Pakistan (DRAP) launched its Digital System for Licensing & Registration of Medical Devices, a new MDMC Licensing and Registration module accessible at https://e.dra.gov.pk/ and https://edrap.dra.gov.pk/. From that date, DRAP no longer accepts manual (paper) submissions for new or renewal establishment licenses or for product registration and enlistment. Legacy applications already in the previous MDMC system continue there until completion. Foreign manufacturers must apply through a local authorized representative in Pakistan, who acts as the applicant on the portal. Use DRAP’s medical device category page for FIFO import lists (Class A–D), portal training materials, and Medical Device Rules 2017 establishment license lists before filing.

Who this applies to

This guide is for organizations that place or intend to place medical devices on the Pakistan market under DRAP oversight:

• Foreign manufacturers exporting devices to Pakistan, who must route applications through a local authorized representative acting as the portal applicant
• Local authorized representatives managing establishment licenses, product registration, and enlistment on behalf of overseas manufacturers
• Pakistan-based importers, distributors, and dealers who need an establishment license before commercial import and supply activities
• Domestic manufacturers seeking establishment licensing and product registration or enlistment for devices manufactured in Pakistan
• Regulatory affairs teams transitioning from paper or legacy e-DRAP workflows to the July 2025 MDMC digital module
• Quality and compliance staff preparing dossiers aligned with Medical Device Rules 2017 (MDR 2017) and DRAP Medical Device Coordination Board (MDMC) requirements

The digital system covers establishment licensing (new and renewal) and product registration or enlistment (new and renewal). If your organization holds an application already submitted under the previous MDMC system, that file remains in the legacy channel until DRAP completes it—you do not restart those cases in the new module unless DRAP instructs you to do so.

Device scope follows Pakistan’s medical device regulatory framework administered by MDMC under DRAP. DRAP publishes FIFO (first-in, first-out) import processing lists segmented by Class A through Class D, which helps importers and representatives track where registered products sit in the import queue. Consult DRAP’s official medical device category page for the current class lists, training resources, and published establishment license registers before planning submissions.

MDMC portal vs old e-DRAP

Understanding the transition from earlier channels to the July 2025 digital system prevents rejected submissions and duplicated applications.

What changed on 21 July 2025

DRAP announced the launch of the Digital System for Licensing & Registration of Medical Devices on 21 July 2025 via its official news channel at dra.gov.pk. The launch introduced a dedicated MDMC Licensing and Registration module within the broader e-DRAP ecosystem. The practical effect for industry is clear:

Portal URLs and module name

Industry should bookmark both official entry points DRAP associates with the digital system:

• https://e.dra.gov.pk/ — e-DRAP platform hosting the new MDMC module
• https://edrap.dra.gov.pk/ — alternate official e-DRAP access point for the same MDMC Licensing and Registration functionality

The module name used in DRAP communications is MDMC Licensing and Registration. It replaces manual intake for establishment licensing and product registration/enlistment while leaving a controlled path open for legacy files.

Legacy MDMC system: what still runs there

Applications already submitted and under review in the old MDMC system continue on that track until DRAP finishes processing them. Do not assume those files automatically migrate to the new module. Regulatory teams should:

1. Confirm whether each open application sits in the legacy MDMC queue or requires action in the new module (typically only for new filings and renewals after 21 July 2025).
2. Monitor DRAP news and category-page updates for any migration or re-submission instructions affecting legacy cases.
3. Avoid duplicate submissions—filing the same product again in the new portal while a legacy application is pending can create conflicting records.

Reference materials on DRAP’s category page

DRAP’s medical device category page consolidates operational resources industry needs alongside the portal:

• FIFO import lists for Class A, B, C, and D — transparency on import processing order for registered devices by risk class
• Training materials — official guidance for navigating the MDMC Licensing and Registration module
• MDR 2017 establishment license lists — published registers of licensed establishments under the Medical Device Rules 2017 framework

Use these resources together: the portal executes submissions; the category page confirms public lists, training, and regulatory context.

Step-by-step workflow

The following workflow reflects DRAP’s July 2025 digital transition and standard MDMC practice for market access. Adjust internal timelines based on dossier readiness and DRAP queue positions shown on published FIFO lists.

Step 1: Confirm product scope and regulatory pathway

Determine whether your device falls under DRAP medical device oversight and whether the appropriate product pathway is registration or enlistment under MDR 2017 (see comparison table below). Identify the device class (A–D) because DRAP publishes separate FIFO import lists by class—your class affects how your product appears in public import queues after approval.

Step 2: Appoint or confirm a local authorized representative (foreign manufacturers)

Foreign manufacturers cannot act as direct portal applicants. Under standard DRAP practice, the local authorized representative in Pakistan serves as the applicant for establishment licensing and product registration or enlistment. Before any portal activity:

• Execute a formal authorization agreement defining the representative’s regulatory responsibilities
• Ensure the representative’s establishment credentials and DRAP profile are current
• Align dossier ownership, technical files, and labeling with the representative’s legal role as applicant

Step 3: Obtain or renew an establishment license (prerequisite for commercial activity)

An establishment license under MDR 2017 authorizes the licensed entity to conduct covered medical device business activities in Pakistan (for example import, distribution, or manufacturing as applicable to the license type). New establishment license applications and renewals must be submitted through the MDMC Licensing and Registration module—manual applications are not accepted after 21 July 2025.

Cross-check your target establishment against DRAP’s published MDR 2017 establishment license lists on the category page before assuming an existing license is valid.

Step 4: Prepare the product registration or enlistment dossier

Compile technical and administrative documentation required under MDR 2017 for the chosen pathway. Regulatory teams should map:

• Device classification (A–D) to DRAP’s class-based import list structure
• Quality management and conformity evidence appropriate to class and pathway
• Labeling, instructions for use, and Pakistan-specific market information
• Relationship between foreign manufacturer and local authorized representative in the application structure

DRAP training materials on the category page describe how to structure uploads in the digital module—review them before first submission.

Step 5: Create or access an e-DRAP account and open the MDMC module

Register or log in at https://e.dra.gov.pk/ or https://edrap.dra.gov.pk/. Navigate to the MDMC Licensing and Registration module. Complete profile and establishment linkage steps as prompted. Incomplete account setup is a frequent cause of submission errors.

Step 6: Submit the application online

Select the correct application type:

• Establishment license — new or renewal
• Product registration — new or renewal
• Product enlistment — new or renewal

Upload dossier files per module instructions. The system replaces manual drop-off or postal submission entirely for these categories after 21 July 2025.

Step 7: Track review status and respond to queries

Monitor application status within the portal. Respond promptly to DRAP deficiency letters or requests for clarification through the digital channel. For products approaching market entry, monitor the relevant Class A–D FIFO import list on DRAP’s category page to understand public queue position after registration or enlistment is granted.

Step 8: Maintain compliance post-approval

After license or product approval:

• Renew establishment licenses through the portal before expiry—renewals are also digital-only
• Renew product registration or enlistment through the portal on schedule
• Update DRAP promptly if authorized representative arrangements or establishment details change
• Use published establishment license lists and class FIFO lists as external verification tools for customers and customs brokers

Establishment license vs product registration

Establishment licensing and product registration/enlistment serve different regulatory purposes under Pakistan’s medical device framework. Both now flow through the MDMC Licensing and Registration module for new filings and renewals.

Registration and enlistment are distinct product pathways under MDR 2017. Teams should confirm the correct route for each device before uploading dossiers—choosing the wrong pathway delays review.

Checklist

Use this checklist before first submission in the MDMC Licensing and Registration module:

Portal and transition readiness

• Confirmed today’s date is on or after 21 July 2025 — manual submissions will be rejected for new/renewal establishment and product applications
• Identified whether each open file belongs in the legacy MDMC system or the new module
• Account access verified at e.dra.gov.pk or edrap.dra.gov.pk
• Reviewed DRAP training materials on the medical device category page

Representative and establishment

• Local authorized representative appointed and documented (foreign manufacturers)
• Representative confirmed as the portal applicant
• Establishment license active, or renewal/new application prepared in the digital module
• Establishment checked against published MDR 2017 establishment license lists

Product dossier

• Device class (A–D) determined
• Correct pathway selected: registration vs enlistment
• Dossier complete per MDR 2017 expectations for that pathway and class
• Labels and IFU reflect Pakistan market and applicant identity

Submission and post-approval

• Application type correctly selected (establishment vs product; new vs renewal)
• All uploads completed in MDMC Licensing and Registration module—no paper copies sent to DRAP
• Internal tracker set for deficiency responses within the portal
• Plan to monitor relevant FIFO Class A–D import list after product approval

Common pitfalls

1. Submitting manual applications after 21 July 2025

DRAP explicitly stopped accepting manual submissions for new and renewal establishment licenses and product registration/enlistment from the launch date. Paper dossiers, courier packages, and email attachments do not replace portal filing.

2. Treating foreign manufacturers as direct applicants

Standard DRAP practice requires foreign manufacturers to apply through a local authorized representative. Applications filed under the manufacturer’s overseas entity without representative authorization typically fail intake or create enforceable compliance gaps.

3. Duplicating legacy applications in the new module

If a product or establishment application already sits in the old MDMC system, do not re-file in the new module unless DRAP instructs you. Duplicate files slow review and can produce inconsistent license numbers.

4. Skipping establishment licensing before product filing

Product registration or enlistment does not replace the need for a valid establishment license for commercial activities. Organizations sometimes prepare product dossiers while establishment licenses lapse—blocking import and supply even after product approval.

5. Confusing registration with enlistment

MDR 2017 provides separate registration and enlistment routes. Submitting an enlistment dossier for a device that requires registration (or the reverse) wastes review cycles. Confirm pathway against MDR 2017 class and device-type provisions before upload.

6. Ignoring DRAP training materials

The category page training materials exist specifically for the new digital module. Teams that guess at field mappings or file naming conventions often trigger preventable deficiencies.

7. Not monitoring FIFO lists and public registers

After approval, Class A–D FIFO import lists and establishment license lists are the authoritative public references for queue position and licensed entities. Failing to monitor them disrupts import planning and customer due diligence.

8. Letting renewals lapse because of portal transition

Renewals for establishment licenses and product registration/enlistment are also digital-only after 21 July 2025. Organizations accustomed to paper renewal cycles miss expiry dates if they do not migrate processes to e-DRAP.

FAQ

What is the official DRAP portal for Pakistan medical device registration?

The official channels are https://e.dra.gov.pk/ and https://edrap.dra.gov.pk/, which host the MDMC Licensing and Registration module launched on 21 July 2025. This is the required portal for new and renewal establishment licenses and product registration or enlistment.

Can I still submit paper applications to DRAP for medical devices?

No. DRAP no longer accepts manual submissions for new or renewal establishment licenses and product registration/enlistment after 21 July 2025. All such applications must be filed through the digital MDMC module.

What happens to applications already in the old MDMC system?

Applications already submitted under the previous MDMC system continue processing in that legacy channel until DRAP completes them. They do not automatically transfer to the new module. New filings and renewals after 21 July 2025 use the MDMC Licensing and Registration module exclusively.

How do foreign manufacturers register medical devices in Pakistan?

Foreign manufacturers apply through a local authorized representative in Pakistan. The representative acts as the applicant on the DRAP portal for establishment licensing and product registration or enlistment. This follows standard DRAP practice for overseas manufacturers entering the Pakistan market.

What is the difference between an establishment license and product registration?

An establishment license authorizes a legal entity to conduct licensed medical device business activities under MDR 2017. Product registration or enlistment authorizes a specific device to be placed on the market. Both are required for lawful commercialization but serve different purposes; both now submit online through the same MDMC module.

Where can I find DRAP FIFO import lists and establishment license registers?

DRAP’s medical device category page publishes FIFO import lists for Class A through Class D, training materials for the digital portal, and MDR 2017 establishment license lists. These public lists complement portal submissions for import planning and compliance verification.

Do establishment license renewals also require online submission?

Yes. Renewals of establishment licenses—as well as renewals of product registration and enlistment—must be submitted through the MDMC Licensing and Registration module. Manual renewal submissions are not accepted after 21 July 2025.

What training resources does DRAP provide for the new portal?

DRAP hosts training materials on its medical device category page covering use of the Digital System for Licensing & Registration of Medical Devices. Regulatory teams should complete this training before first submission to reduce formatting and upload errors.

Official sources

• Drug Regulatory Authority of Pakistan (DRAP) — News announcement: launch of Digital System for Licensing & Registration of Medical Devices, 21 July 2025 — https://dra.gov.pk/
• e-DRAP portal (MDMC Licensing and Registration module) — https://e.dra.gov.pk/
• e-DRAP alternate access — https://edrap.dra.gov.pk/
• DRAP medical device category page — FIFO import lists (Class A–D), portal training materials, MDR 2017 establishment license lists — https://dra.gov.pk/ (medical devices section)