Pakistan Label Language: English and Urdu

1. Key takeaways

The practical estimate on label language in Pakistan is a division by use scenario: for devices intended for professional or healthcare-institution use, the label and instructions for use may be in English only, while for devices intended for ordinary consumers or home use, the key safety information and basic instructions for use must be provided in Urdu (the national language of Pakistan), with the English information permitted to remain alongside. This position is subject to source divergence, and written confirmation is recommended before mass-production packaging. The scenario split reflects a principle that recurs across jurisdictions: language requirements track the reader, not the product. A device operated by trained clinicians can live with a single technical language, because its readers share it; a device opened on a kitchen table must speak the language of whoever picks it up, because at home there is no interpreter standing by and the consequence of a misunderstood warning lands directly on a member of the public. The residual uncertainty in the Pakistani position is therefore not about the principle but about its boundary cases, which is precisely what the pre-production confirmation step is for.

The confirmation step deserves a word of method. Because the scenario split rests on the practical estimate rather than on rule text, the confirmation should be sought from the side that will apply the position: the authority through the registration process, or the importer whose clearance experience will reveal how inspectors read the pack. The confirmation should be specific, naming the device, its intended use scenario and the proposed language arrangement, because a general question generally receives a general answer, and a general answer will not defend a printed carton. Once obtained, the written position converts the divergence from a standing doubt into a documented basis, and the labelling line can be released for production with the risk carried on paper instead of in the dark.

• For professional or healthcare-institution use: the label and instructions for use may be in English.
• For home or consumer use: the key safety information and basic instructions for use must be in Urdu.
• Registration documentation may be in English.
• The local representative’s information must appear on the label under Rule 24(b).
• Label consistency with the approved version is governed by Rule 14(6).
• Because the language position carries source divergence, it is recorded as pending verification until confirmed in writing.

2. Legal basis

The table below shows the uneven legal footing of the language position: the scenario rules rest on the practical estimate drawn from registration practice, while two adjacent requirements, the representative information and label consistency, rest squarely on the text of the rules. The mix explains why written confirmation is prudent before packaging decisions are locked.

3. Expert insights

Insight one: for professional devices, English suffices, which matches the conclusion reached for Bangladesh. The DGDA guidance of Bangladesh, at §7.2, does not require Bengali, and practising professionals interviewed there likewise confirmed that English is sufficient. The two countries hold the same position on the label language for professional-use devices. The convergence is convenient for regional portfolio planning, because a single English-language professional labelling package can be designed once and carried across both markets with only the country-specific elements, such as the local representative’s details and the local registration number, differing between them.

Insight two: home-use devices are the high-divergence zone and the enforcement focus. The Pakistani practical estimate requires home-use devices to provide key information in Urdu. This aligns with the regulatory logic that home-use devices face ordinary consumers, and the comprehensibility of language bears directly on public safety. It is no accident that the divergence among sources concentrates exactly here: consumer labelling is where national-language policy, consumer protection instinct and market practice intersect most sharply, and where an enforcement officer’s judgement is most likely to be exercised.

Insight three: language requirements stack with the label consistency rule, and the stack magnifies the cost of change. Rule 14(6) requires the label to match the approved version, and changing the representative changes the representative information shown on the label. Replacing the authorised representative therefore necessarily triggers a label update and change formalities, a point that stands as a core constraint in the structural design of article 49 of this series. The interaction is the point: neither rule is heavy alone, but together they mean that a commercial decision, changing representative, arrives with mandatory labelling consequences attached, and the cost should be priced into that decision before it is taken.

4. Practical recommendations

• Adopt the labelling strategy of an English core with an Urdu supplement for home-use devices: professional devices in English; for home-use devices, add an Urdu supplementary label carrying the product name, the warnings and the basic operating steps alongside the English core information.
• This satisfies the English-led expectation, covers the language comprehensibility of the home-use scenario, and keeps the divergence risk to a minimum.
• Arrange written confirmation of the language position before mass-production packaging, and file the confirmation with the project record.
• Bring label versions under change management, and record the language position divergence as a pending verification item until it is closed.

5. Verification checklist

• □ Label language strategy determined by use scenario
• □ Professional-use device labels in English
• □ Home-use devices carry the key information in Urdu
• □ Written confirmation arranged before mass-production packaging
• □ Label versions under change management
• □ Language position divergence recorded as a pending verification item

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