Device Recalls and Field Safety Corrective Actions in Pakistan

1. Key takeaways

The handling of device safety issues in Pakistan is led by DRAP, while the registration holder carries the responsibility for execution and reporting. The chain runs broadly as follows: identify the problem, assess the risk level, take a field safety corrective action (FSCA) or a recall, report to DRAP, and then complete the corrective action and close the case. Because the registration holder is the statutory anchor of liability (Rule 14(1)(b) together with the Pharmacovigilance Rules, 2022), even when the problem originates with the overseas manufacturer, the first point of contact for DRAP remains the Pakistani licence-holding party. This allocation of roles is not a matter of negotiation between the parties; it follows directly from who is named on the certificate. A foreign manufacturer therefore cannot assume that its own global quality procedures will satisfy the local authority by themselves. The distinction between a recall and an FSCA also matters in practice: a recall removes product from the market, while an FSCA may correct, warn or otherwise reduce risk without removing every unit, and choosing the right instrument for the right risk level is itself part of the expected response. Whatever the manufacturer decides internally, the communication with DRAP flows through the local registration holder, and the holder must be equipped, contractually and operationally, to speak for the product when a safety issue arises.

2. Legal basis

The instruments behind each step of the chain are summarised below. Two provisions of the Medical Devices Rules, 2017 define the holder identity and the certificate consequences; the Pharmacovigilance Rules, 2022 supply the data duty; and the distribution practice standard supplies the traceability foundation on which any recall physically depends.

3. Expert insights

Insight one: Rule 15(4) attaches cancellation or suspension to the five-year validity. The provision states that the certificate is valid for five years, “unless cancelled or suspended”. This means the validity period is not an absolute guarantee but a conditional one — a safety event that is handled poorly can directly threaten the survival of the certificate itself. Companies sometimes read the five-year term as an entitlement and plan revenue on that assumption. The conditional wording says otherwise: the certificate persists only for as long as the holder manages its post-market duties properly, and a recall or FSCA mishandled at the moment of crisis converts a market authorisation into an administrative target. The wording also shifts the burden of proof onto the holder: if the authority questions the handling of an event, it is the holder that must demonstrate the response was adequate, not the authority that must demonstrate it was not.

Insight two: the expert panel under Rule 15(1) is the technical force within the handling chain. The MDB can assemble an expert panel composed of inspectors and auditors. This means the assessment of a risk event may not remain at the document level; where necessary it can extend to the site. A holder that prepares only written explanations for a safety review may therefore find the scope of review widened into physical verification of premises, storage and records. The practical lesson is to keep the physical state of operations consistent with the written file at all times, because the authority retains the option to test one against the other.

Insight three: GDPMD traceability records are the execution basis of any recall. A recall can only locate specific batches and their flow through the market by relying on the traceability records retained across the distribution stage. On projects GRZAN requires the client’s Pakistani partners to keep complete inward and outward warehousing ledgers and flow records; otherwise a recall remains an exercise on paper, with no ability to demonstrate to DRAP which lots went where and which have been recovered. Traceability is not an administrative nicety — it is the mechanism that makes the recall physically executable, and the absence of records is the difference between a closed case and an open question mark in the authority’s file.

4. Practical recommendations

The recall plan that GRZAN prepares for clients contains four parts: grading criteria, stating under what circumstances a recall is triggered and under what circumstances an FSCA alone suffices; notification templates, prepared for DRAP, for distributors and for hospitals; a traceability procedure, locating product flow batch by batch; and closure criteria, defining how completion of the corrective action is confirmed. This set of documents normally sits unused, but it must be finalised before the first shipment leaves, not drafted after the first defect appears. The reason is timing: once an event occurs, every day spent designing templates and agreeing grading criteria is a day of exposure, and the authority judges the quality of the response on the speed and coherence of the first notification. A rehearsed plan also protects the relationship between the manufacturer and the licence holder, because each side already knows its role and the cost allocation has been agreed in advance rather than argued mid-crisis. In GRZAN’s experience the four parts are not equal in effort: the traceability procedure is the one that exposes weaknesses in the distribution chain earliest, and running it once before launch is a cheap rehearsal compared with running it for the first time during a live event.

5. Verification checklist

• □ Trigger criteria for recalls and FSCAs have been defined
• □ Notification templates for DRAP have been prepared
• □ A batch-level traceability mechanism has been established (GDPMD basis)
• □ Criteria for completion and closure of corrective actions have been defined
• □ The party bearing recall costs has been agreed in the contract

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