GDPMD and Market Surveillance Inspections for Devices in Pakistan

1. Key takeaways

Devices circulating in Pakistan are subject to Good Distribution Practice for Medical Devices (GDPMD). Provincial health departments administer sales and distribution activities, while DRAP conducts on-site inspections of storage facilities. The inspection focus concentrates on three items: temperature control, hygiene conditions and storage capacity. Market patrols, for their part, cover distribution qualifications, label compliance and product condition. For imported brands there is a structural discomfort in this arrangement: the warehouse is their weak point, because the licence-holding party usually does not directly control the warehouse. The company that owns the certificate and the company that owns the shelf space are often different legal entities, operating under different management systems, and the regulator inspects the second on the strength of the first. An imported brand therefore inherits every weakness of its partner’s storage operation. Managing distribution compliance in Pakistan means managing an operation you do not own, which requires contractual leverage, periodic verification and a willingness to act on what the verification finds. The practical risk is asymmetric as well: distribution failures accumulate quietly, in the form of drifted refrigerators and incomplete ledgers, long before any single incident makes them visible to the regulator.

2. Legal basis

The relevant provisions are set out below. They cover the inspection power over facilities, the limited exemption route, and two label requirements that market patrols examine most directly. The distribution practice standard itself sits alongside the rules as the operational benchmark against which storage and distribution performance is judged.

3. Expert insights

Insight one: the on-site inspection examines whether goods can be stored properly, not whether a licence exists. The three focus items — temperature control, hygiene conditions and storage capacity — are in essence a verification that the storage conditions match the storage requirements stated on the product labelling and instructions for use. A licence only opens the door to the warehouse; what the inspectors evaluate inside is physical reality. Cold chain products are the most likely to get stuck here, because a cold room that works on paper but drifts in practice fails the test precisely at the parameter that matters most. Companies with ambient products should not relax either: humidity, cleanliness and shelving capacity are assessed with the same seriousness, and a warehouse that mixes product categories must satisfy the strictest applicable requirement among them.

Insight two: the exemption in Rule 15(2) targets the inspection of manufacturing sites and does not exempt warehousing. We highlight this point specifically: the exemption available through reference-country approvals points to inspection of the manufacturing site; the storage and distribution conditions after import into Pakistan remain within the scope of regulation. The confusion arises because both inspections involve the word “site”, but they examine different premises in different countries under different standards. A manufacturer that holds approvals from a recognised reference jurisdiction should not conclude that its Pakistani warehouse inherits the exemption. Goods that left a well-inspected factory can still be ruined in an uninspected storeroom, and the regulator’s concern follows the product, not the factory gate. Reading the exemption narrowly is therefore the safe interpretation, and any broader reading should be confirmed with the authority before it is relied upon in a submission.

Insight three: the label is the most immediately visible check item in market patrols. Rule 24(b) requires local representative information on the label, and Rule 14(6) requires the label to be consistent with the approved version. These two requirements hold simultaneously, which means the label must carry the Pakistani information and must not deviate from the approved version of the country of origin or the reference country — this needs to be coordinated at the design stage, not patched afterwards. A label revised late in the process tends to satisfy one requirement and violate the other, because the local additions push the artwork away from the approved master. Early artwork planning with both rules on the table avoids that collision entirely, and it costs nothing except an earlier decision on where the Pakistani text sits on the layout.

4. Practical recommendations

GRZAN’s approach at the distribution stage is the three-check routine: check the warehouse, examining temperature and humidity recording equipment together with its historical data; check the ledgers, confirming that inward and outward records and flow records are traceable; and check the labels, comparing the physical goods accompanying shipments item by item against the approved artwork. These three checks are performed at least once every year, and they must be repeated in full whenever the warehouse operator changes, because a change of operator resets every assumption about equipment, personnel and records. The checks are deliberately simple, since their purpose is not to replace the authority’s inspection but to find problems before the authority does. A finding recorded in an internal check leads to a corrective action on the company’s own schedule; the same finding recorded by an inspector leads to a corrective action on the regulator’s schedule, with the certificate implications that follow from it. The order of the three checks is also deliberate: the warehouse check verifies conditions, the ledger check verifies traceability, and the label check verifies conformity, so together they cover the three subjects that patrols and inspections respectively target.

5. Verification checklist

• □ The warehouse has passed the DRAP on-site inspection (temperature control / hygiene conditions / storage capacity)
• □ Temperature and humidity recording equipment is in use and historical data is retained
• □ Inward and outward ledgers and flow records are traceable to batch level
• □ Shipping labels carry the local representative name and address (Rule 24(b))
• □ Labels have been checked against the approved version of the country of origin or reference country (Rule 14(6))

Regulatory information verified as of October 28, 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