Pakistan Establishment Licence Categories for Medical Devices

1. Key takeaways

Pakistan applies a dual-track establishment licence system for medical device entities: import activities and local manufacturing activities are each licensed separately by DRAP, and the corresponding application forms differ (Form-1 for manufacturing and Form-2 for importing), while sales licensing at the wholesale and distribution level is administered by the provincial health authorities under the Drug Sale Licence (DSL) framework. For an imported brand, what really determines whether it can submit a product application at all is the import establishment licence — it is the sole credential of applicant eligibility under Rule 14(1)(b).

The practical consequence of this structure is that a market-entry plan for Pakistan cannot be built around a single licence. A foreign manufacturer entering the market must map out, before any dossier is filed, which entity will hold the import establishment licence, which entity will handle distribution, and whether the two roles can legally sit within one company or should be separated. Because the licensing authority for registration sits at the federal level with DRAP while sales licensing sits with the provinces, the responsibility chain has to be stitched together contractually. Companies that discover these split requirements only after shipping their first consignment usually face avoidable delays at the port of entry, so the licence map should be treated as a prerequisite document for the whole project, revisited whenever the distribution model or any participant changes.

2. Legal basis

The table below summarises the legal sources governing establishment licences in Pakistan, the allocation of eligibility between manufacturing and importing entities, and the procedural channel now in force.

Two points in this table deserve emphasis. First, the eligibility test for a product application is not a general one: it is anchored in a specific sub-rule that names the importer, the authorised representative role, and the valid establishment licence together. Second, since 21 July 2025 the licensing and product pathways run through the same online portal, which means the establishment licence file should be complete and current before product submissions begin.

3. Expert insights

Insight 1: the establishment licence is not one licence that travels everywhere; it is split by the nature of the activity. Importing and local manufacturing correspond to different licence tracks and different forms, and an entity that wants to import and distribute at the same time normally needs to hold the respective qualifications separately. This is a common blind spot for manufacturers entering Pakistan for the first time. Many companies assume that once a product certificate is granted, commercial activity can start immediately, only to find that the activity-specific licence underneath the certificate does not cover the transaction they are about to execute. Mapping each planned activity — importation, storage, wholesale, distribution — against the correct licence track at the planning stage prevents this mismatch.

Insight 2: product applicant eligibility and the establishment licence are bound together. The wording of Rule 14(1)(b) is “an importer in his capacity as authorized representative in Pakistan having valid establishment licence” — note that three conditions must hold simultaneously: the identity is an importer, the role is authorised representative, and the entity holds a valid establishment licence. If any one of the three is missing, the applicant is not properly qualified. In practice this means the quality of the establishment licence file directly determines the admissibility of every product application that follows, and a lapse or variation in the licence can invalidate an otherwise complete dossier.

Insight 3: authority over the distribution segment sits with the provinces. Sales licences for drugs and devices in Pakistan are issued by the provincial health authorities under the DSL framework, while DRAP is responsible for national-level registration of therapeutic goods and importation. This means the three segments of holding the licence, importing, and distributing may fall under the jurisdiction of different authorities, and the responsibility chain has to be joined up through contracts. A distribution agreement should therefore allocate obligations for licence maintenance, record keeping, and inspection cooperation explicitly, rather than assuming that one federal certificate answers every question.

4. Practical recommendations

GRZAN’s approach is to draw a three-column table of “entity — qualification — activity”: the first column lists every participant (the foreign manufacturer, the Pakistani licence-holding importer, the warehouse operator, the distributor), the second column records the type of licence each participant should hold and its validity period, and the third column states which link in the chain that participant is responsible for. Once this table is drawn up, qualification gaps and overlapping responsibilities are exposed at the same time. We recommend finalising it at the project kick-off meeting, before any application is drafted. The table also becomes a living compliance tool: whenever a participant changes, a licence expires, or a new activity is added, updating the table immediately shows whether the licence map still holds. Teams that maintain this habit rarely encounter the classic failure mode of discovering, mid-shipment, that no entity in the chain actually holds the licence required for the transaction in progress. In our experience, the twenty minutes spent building and maintaining this table repay themselves many times over across the five-year life of the licences involved.

5. Verification checklist

• □ Confirmed that the importer holds a valid import establishment licence (Form-2)
• □ Confirmed that the local manufacturer (if applicable) holds a Form-1 licence
• □ Confirmed the attribution and status of the provincial sales licence (DSL) for the distribution/wholesale segment
• □ Confirmed the staggered arrangement between the establishment licence validity and the product enlistment/registration validity (both 5 years)
• □ Marked each entity’s responsible segment in the three-column table

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