Pakistan Import of Medical Devices for Donation under Rule 24A

1. Key takeaways

Pakistan maintains a dedicated exception pathway for the import of medical devices for donation: Rule 24A of MDR 2017. The provision was added by S.R.O. 559(I)/2022 (dated 27 April 2022). Its position is an exception, not an exemption: donated devices still have to go through DRAP’s approval procedure, and documents proving the donation relationship and product compliance still have to be submitted — only the documentation requirements differ from those for ordinary commercial importation.

The distinction between exception and exemption is the heart of the rule. Donation programmes often arrive with urgent humanitarian timelines, and the pressure to move quickly is exactly what makes the approval step tempting to skip. It cannot be skipped without jeopardising the entire consignment. What Rule 24A changes is the shape of the file — who certifies what, and which documents evidence the donation — not the existence of regulatory oversight. Approval still has to be obtained from DRAP before the goods move, and the file supporting it has to be assembled with the same care and the same traceability as any commercial dossier. Projects that internalise this at the outset build realistic timelines and honest donor expectations; projects that treat the rule as a fast lane without requirements meet the regulator for the first time at the port. The correct posture is to treat Rule 24A as a defined route with its own document set, mapped early, budgeted realistically, and staffed like any other regulatory submission.

2. Legal basis

The table below records the amendment that created Rule 24A, the rule itself, and the related import provisions.

The amendment context matters as much as the rule itself. Because Rule 24A was introduced in the same instrument that deleted Rule 25 and replaced Rule 27, citations from before April 2022 do not reflect the current structure of the rules, and any legacy document should be re-checked against the post-amendment text before it is relied upon. This is particularly relevant for donation projects, whose templates and precedent files tend to circulate for years without systematic review, quietly carrying pre-2022 references forward into new projects.

3. Expert insights

Insight 1: Rule 24A and the refurbished device definition appear in the same amendment, and that is no coincidence. S.R.O. 559(I)/2022 introduced the definitions of refurbished medical device and refurbishment at the same time. This signals that the donation pathway and refurbished devices are adjacent topics in regulatory terms — if donated consignments contain refurbished equipment, the application of the definitions needs additional attention. Organisations managing donation programmes should therefore ask, for every unit offered, whether it is new, used, or refurbished in the regulatory sense, because the answer determines which documentation expectations attach to it. A written confirmation of condition from the donor, obtained before the consignment is packed and shipped, is the cheapest point in the chain to settle the question.

Insight 2: the same amendment both deletes and adds, which shows the framework is being rebuilt as a whole. S.R.O. 559(I)/2022 deleted the original Rule 25, replaced Rule 27, and added Rule 24A. This is the typical style of amendment of Pakistan’s device rules — adjusting several segments in one stroke — so whenever a rule is cited, the current version must be checked, and the numbering of an older version cannot be carried over. The safe habit is to date-stamp every citation and to re-verify it against the official gazette text whenever a document is reused, however routine the reference seems. A citation habit built on the original 2018 text will, over time, point to provisions that have moved, changed meaning, or ceased to exist.

Insight 3: an exception pathway does not mean entry without approval. Donation imports still require DRAP approval. Understanding the exception pathway as an exemption from approval is the most common mistake in aid-type projects. The error usually originates in good intentions — a donor assumes that a gift needs no licence — but the consequence lands on the importer of record, and it lands there quickly: consignments held at the port serve neither the donor nor the recipient. Early engagement with the approval process is therefore a service to the donation itself, not an obstacle placed in its way, and the organisations that plan for it consistently deliver their consignments faster than those that improvise.

4. Practical recommendations

When GRZAN assists donation-type projects, the first task is to confirm the correspondence between the recipient’s qualifications, the content of the donation letter, and the product compliance documents. The product names, models, and quantities on the donation letter must match the accompanying documents and the labels; if any item does not correspond, additional checks will arise at the port. We recommend running a document consistency pre-check before shipment, covering the donation letter, the packing list, and the product labelling line by line, with any discrepancy resolved and documented before the goods leave the origin warehouse. Donation consignments are especially exposed to this check because they are assembled under time pressure and often across several donors, which is precisely when mismatches creep in most easily; a disciplined pre-check costs hours, while a port hold costs weeks. The pre-check also documents diligence for the donor organisation, which increasingly requires documented evidence that its gift will clear regulatory scrutiny before it authorises the shipment.

5. Verification checklist

• □ Confirmed that Rule 24A applies (import for donation purposes)
• □ DRAP approval document obtained
• □ Donation letter content consistent with product names, models, and quantities
• □ Accompanying documents consistent with the labels
• □ If refurbished equipment is included, the application of the refurbished medical device definition checked

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