Pakistan Legacy MDMC Applications: No Duplicate Filing in the New Module

1. Key takeaways

Applications already submitted in the old MDMC system before 21 July 2025 continue to be processed on the legacy channel and are not automatically migrated to the new module. New applications and renewals from 2025-07-21 onward must all use the new MDMC licensing and registration module. Where the same product is already pending in either the old or the new system, it must not be filed again in the new module without instruction from DRAP — duplicate dossiers slow down evaluation and can produce inconsistent licence numbers. The transition therefore demands one thing above all from sponsors: knowing, for every single application, exactly which track it currently sits on. That knowledge is not something the systems will hand over automatically — the applicant must go and confirm it, application by application, because nothing about the launch date tells an individual sponsor where its own pending work has landed.

• Applications submitted before 21 July 2025 stay on the legacy channel until DRAP completes them; there is no automatic migration to the new module.
• All new applications and renewals from 2025-07-21 onward go exclusively through the new MDMC licensing and registration module.
• Re-filing a product that is already pending in either system, without DRAP instruction, is prohibited practice — the risks are slower evaluation and inconsistent numbering.
• The two systems run in parallel during the transition, so track identification must precede every filing decision.

2. Legal basis

The transitional arrangement rests on DRAP’s notice of July 2025 and the portal launch date published on the DRAP website. The risks attached to duplicate filing come from registration practice compilation and are marked as a practical estimate rather than a statutory sanction.

3. Expert insights

Insight one: this is a dual-track transition, not a one-time switchover. The old and new systems run simultaneously for a period, and companies must first confirm which track their dossier is on before deciding their next move. During such transitions the most dangerous assumption is the unstated one — that everything moved when the new system launched. In reality the authority deliberately kept pending work where it is, and the burden of knowing the position falls on the applicant. A sponsor who cannot say, for each product, whether it sits on the legacy channel or the new module, is navigating the transition blind, and blind navigation at this particular junction leads directly to the duplicate-filing error described below.

Insight two: duplicate filing is the most expensive mistake available in this transition. In the paper system, a duplicate submission was merely an extra document in a pile; in the digital system, duplicate dossiers occupy the evaluation queue and can produce inconsistent numbering, and the later cost of withdrawing and consolidating them is high. The expense is not the second filing fee but the downstream untangling: two records describing one product, evaluation resources spent twice, and a register entry that may need correction before the certificate is usable in commerce. Because every duplicate is visible in the same database, it is also the kind of error that is discovered precisely when it does the most damage — at approval or issuance time, when the inconsistency in numbering surfaces and must be resolved before anything can proceed.

Insight three: the transition reveals DRAP’s pace of digitalisation. Medical devices were the last major category to migrate to PSW, following drug active ingredients and finished products (see the related guides in this series). Companies should treat the continued evolution of portal rules as a long-term assumption, not a one-time adaptation exercise. A compliance function built for the portal as it exists on launch day will be outdated within a cycle; the practical posture is standing regulatory watch on portal notices, integrated into the same monitoring that tracks the underlying rules. That watch costs little to maintain and pays for itself the first time a procedural change is caught before it catches a filing off guard.

4. Practical recommendations

At project handover, GRZAN first performs a system status confirmation: it checks each product one by one for whether it currently sits on the legacy channel or the new module, and records the application number and status.

• Confirm, application by application, which system each product currently sits on (legacy channel or new module) before any new filing action is considered.
• Record the application number and current status for every pending application during the confirmation exercise, so the picture is documented rather than remembered.
• Initiate no new submission actions until the track identification is complete.
• For applications under processing on the legacy channel, require the local partner to keep following up through the original channel — not to re-file for the sake of moving to the new system faster.
• Maintain a dual-track ledger covering both systems, so the portfolio view stays accurate while the transition runs.
• Confirm that any renewal due during the transition uses the new module, consistent with the channel rules for renewals.

5. Verification checklist

• □ Confirmed which system each application currently sits on (legacy channel / new module)
• □ No legacy-channel application has been re-filed in the new module
• □ Application numbers and payment receipts have been archived
• □ A dual-track ledger covering the old and new systems has been established
• □ Renewal applications have been confirmed to use the new module
• □ Portal rule evolution has been added to the regulatory monitoring list

Regulatory information verified as of 28 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across South Asia, including Pakistan. Our team prepares dossiers to DRAP expectations, manages eCTD-format submissions and deficiency responses, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com