Pakistan Labelling Requirements: Ten Elements

1. Key takeaways

The labelling rules for medical devices in Pakistan are set out in Chapter VI of the Medical Devices Rules 2017. A label must contain at minimum: the device name and model, the manufacturer’s name and address, the name and address of the authorised representative within Pakistan, the country of manufacture, the batch number or serial number, the manufacturing date and expiry date (where applicable), storage conditions, the instructions for use or a reference to them, the regulatory classification, and the DRAP enlistment or registration number. Ten elements, each traceable to the chapter, together define what a compliant Pakistani label looks like. The list is worth reading as a system rather than as a heap of items: the first elements identify the product and the parties behind it, the middle elements carry the traceability and handling information that keeps the product safe in storage and use, and the closing elements, the classification and the DRAP number, tie the physical pack to the regulatory record that authorises its presence on the market. A label missing any element is incomplete in a way that is visible to any inspector who picks the pack up.

The ten elements also reward early engineering attention, because several of them cannot simply be added at the end of a packaging project. The representative’s details must exist before the artwork can be finalised, which means the authorization arrangement precedes the artwork; the DRAP number does not exist until a certificate is granted, which means the artwork must accommodate it in advance, whether through a reserved field or a planned reprint; and the expiry date logic depends on how shelf life was established in the technical documentation. Companies that treat labelling as a print-shop task discover these dependencies late, while companies that treat it as a regulatory deliverable sequence them from the start, and the difference shows up in how calmly the first shipment clears.

• Device name and model.
• Manufacturer’s name and address.
• Name and address of the authorised representative within Pakistan.
• Country of manufacture.
• Batch number or serial number.
• Manufacturing date and expiry date (where applicable).
• Storage conditions.
• Instructions for use or a reference to the IFU.
• Regulatory classification.
• DRAP enlistment or registration number.

2. Legal basis

The table below locates each of the ten elements in its source. Most rest on Chapter VI of the rules, which governs labelling and packaging; two elements carry additional or specific anchors, the local representative’s details in Rule 24(b) and the registration number in the certificate provisions tied to the Form-8 / Form-8A formats.

3. Expert insights

Insight one: placing the local representative’s information on the label is mandatory in Pakistan. Rule 24(b) and Chapter VI together require the label to show the name and address of the authorised representative within Pakistan. This puts the licence holder’s information onto the product as it enters the market, and changing the representative therefore triggers a label change. The design has real consequences: the label becomes a public statement of who answers for the device in Pakistan, and any change of representative is not merely a contractual event but a visible, physical one, reaching every pack in the supply chain.

Insight two: putting the DRAP enlistment or registration number on the label is the most practical enforcement-facing element of the design. During market inspection, an officer can verify the registration status directly against the number printed on the label. A product without the number on its shelf packaging is, for inspection purposes, a product whose authorisation cannot be checked. The number thus functions as the hinge between the physical market and the regulatory register, and its absence converts an authorised product into one that looks unauthorised, with all the friction that impression creates at the point of sale.

Insight three: the label artwork serves as both a registration document and a customs clearance document. At the registration stage the label artwork is submitted; at the clearance stage the actual label is checked. Both stages apply the same set of requirements, so the artwork should be prepared once, correctly, for both. Teams that maintain two versions of the label, one idealised for the dossier and one pragmatic for the port, create a divergence that sooner or later surfaces as a discrepancy between what was approved and what arrived, and resolving that discrepancy costs far more than preparing a single truthful artwork would have.

4. Practical recommendations

• At the registration stage, produce the final label artwork against the ten elements of Chapter VI and use that same artwork for clearance checks, avoiding the split of one version for registration and another for clearance.
• Require clients to bring label versions under change management: every label revision carries a version number and an effective date, so later verification always has a baseline.
• Treat any change of authorised representative as a label-change event from the outset, with artwork revision planned into the transition.
• Verify the printed DRAP enlistment or registration number against the certificate before shipment, since the number on the pack is what inspectors will read.

5. Verification checklist

• □ Label contains the device name and model
• □ Label contains the manufacturer’s name and address
• □ Label contains the name and address of the authorised representative within Pakistan
• □ Label contains the country of manufacture and the batch or serial number
• □ Label contains the manufacturing date and expiry date (where applicable)
• □ Label contains storage conditions and the IFU reference
• □ Label contains the regulatory classification and the DRAP enlistment or registration number

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