Pakistan: Licence Holder versus Distributor Structure for Medical Devices

1. Key takeaways

In Pakistan, the licence holder (the holder of the enlistment or registration certificate) and the distributor can be the same entity, or can be split into two separate entities. The rules do not prohibit combining the two roles; but from a risk-control perspective, separating registration holding from channel distribution is the more resilient structure for imported brands. The reason is simple: Rule 14(1)(b) determines that the applicant can only be an importer holding an establishment licence — whoever is the licence holder is also the importer, and therefore also bears the statutory responsibilities for importation and vigilance.

This pairing of roles is what makes the structural choice consequential rather than cosmetic. The certificate holder appears on the certificate, on import documentation, and in the vigilance system, so it is the entity every regulator will contact first. If that entity is also the commercial distributor, regulatory control and commercial interest merge in the same hands. A carefully drafted agreement can soften some of the friction, but it cannot move the certificate to another company without a formal transfer. The decision on structure should therefore be made once, deliberately, at market entry — not defaulted into by whoever signs first. It should also be revisited before each renewal cycle, because the bargaining position of the parties rarely stays static over five years.

2. Legal basis

The table below sets out the provisions that shape the licence-holder and distributor relationship in Pakistan, from applicant eligibility through certificate format to post-market obligations.

Read together, these provisions explain why the structure question matters. The rules fix who may apply, what the certificate looks like, how long it lasts, and who carries the vigilance burden afterwards. None of these elements can be reallocated by private agreement; they follow the certificate itself. For Class A devices the certificate is issued as an enlistment, while Class B, C and D devices go through full registration, but the structural analysis for the applicant is identical in both categories.

3. Expert insights

Insight 1: under a combined structure, a commercial dispute turns directly into a compliance risk. If the licence holder is also the distributor, then once the two sides disagree over sales volumes, rebates, or territory, the licence holder holds the registration certificate — it can refuse to cooperate on renewal, refuse to transfer the certificate, and withhold import documentation. This is not unlawful at the level of the rules, but commercially it is almost impossible to counter. Foreign manufacturers in this position typically have no parallel import channel into Pakistan, so every shipment into Pakistan depends on the goodwill of the very entity they are in dispute with. This dependency is the single strongest argument for formally separating the two roles at the outset.

Insight 2: the key to a split structure is that the licence holder must hold its own establishment licence. This is not something that can be delegated to the distributor. The licence holder has to be able to import and has to be able to fulfil vigilance reporting, so it must be a licensed importing entity, not a shell company. A nominee arrangement in which the licence holder performs no real functions creates problems on both sides: the regulator sees an entity that cannot discharge its statutory duties, and the manufacturer relies on an entity with no operational substance. Diligence on the prospective licence holder should therefore cover its import track record, warehouse arrangements, and capacity to run vigilance processes, and the answers should be documented before the letter of authorisation is signed rather than after.

Insight 3: the name on the certificate determines where responsibility sits, regardless of what the underlying agreement says. However the internal arrangements are documented, DRAP will only deal with the entity recorded on Form-8A. Internal agreements can allocate losses between two civil parties, but they cannot be invoked against the regulator, and no clause in a distribution contract can move a statutory duty onto a different entity. This is why the drafting quality of the agreement matters so much: it is the only instrument that actually governs the relationship, and it must anticipate the scenarios — renewal, transfer, termination — in which the divergence between legal form and commercial reality becomes acute.

4. Practical recommendations

GRZAN’s structural advice to manufacturers usually comes in three stages: at the testing-the-water stage, use an independent licence holder (without a channel role); at the scale-up stage, separate the licence holder from the distributor but sign a coordination agreement; at the maturity stage, consider holding the certificate through your own entity. At every stage, the contract must state three things clearly: who keeps the original registration certificate, who initiates the renewal, and how transfer cooperation works when the cooperation ends. Once these three points are written down clearly, the risk becomes fully manageable. We also recommend recording who bears the renewal fee and who responds to deficiency letters, because these are the two moments at which an ambiguous split structure most often breaks down in practice. Finally, the coordination agreement should oblige the distributor to report field observations and complaints to the licence holder within a defined timeline, since the vigilance duties under the Pharmacovigilance Rules, 2022 rest on the certificate holder and cannot be shifted downstream by silence.

5. Verification checklist

• □ Determined whether the licence holder and the distributor are separated
• □ Licence holder possesses a valid import establishment licence
• □ Custody responsibility for the original registration certificate agreed
• □ Initiating party for renewal and the fee-bearing party agreed
• □ Transfer cooperation obligations and timelines on termination agreed

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