Pakistan Labelling Same as Country of Origin under Rule 14(6)

1. Key takeaways

Rule 14(6) of the Medical Devices Rules 2017 provides that the complete label and prescribing information of a device, where applicable, must be identical to the version approved in the country of origin, or to the version approved in the European Union, the United States, Japan, Canada or Australia. This is a written technical constraint in the rules themselves: a company cannot design a separate label for the Pakistani market that differs from the approved version of the reference country. The provision converts labelling from a free design exercise into a bounded one, where every element the applicant wishes to add or adjust for Pakistan must find its place within, or alongside, a version that some other authority has already approved. The discipline this imposes is considerable, but so is the clarity: the baseline against which a Pakistani label is judged already exists, is written down, and was approved by a named regulator, so the only question ever in dispute is whether the Pakistani presentation preserves it.

The practical effect on multinational portfolios is a single-source-of-truth discipline for labelling. Because the Pakistani label must mirror an approved version, the approved version itself becomes the controlling document, and the moment it changes, a dozen markets feel the tug through their own consistency rules. Companies that keep one canonical record of the approved label, with change history and effective dates, can answer a Pakistani consistency question in minutes; companies whose approved versions live in institutional memory, in old artwork files and in the recollection of a former product manager, cannot, and every label revision then becomes an archaeology exercise. The rule is Pakistani, but the capability it demands, controlled documentation of the approved version, is simply good labelling governance anywhere.

• Labels and prescribing information must match the approved version (Rule 14(6)).
• The approved versions that satisfy the rule are those of the country of origin or the five reference jurisdictions.
• General labelling requirements are set in Chapter VI.
• The local representative’s information must appear on the label (Rule 24(b)).
• The certificate and the enlistment or registration number issue under Rule 15(3) and (5).
• Added content must take the form of a supplement to the approved version, not a replacement of it.

2. Legal basis

The anchors below gather the provisions that surround Rule 14(6): the consistency duty itself and its scope, the general labelling chapter into which the mandatory Pakistani elements fit, the representative information requirement, and the certificate provisions that supply the registration number the label must carry.

3. Expert insights

Insight one: this rule turns label localisation into a constrained action. Unlike the Bangladesh guidance at §7.2 note 3, which permits relabelling to be performed while goods are held in quarantine, the Pakistani rule requires the label to remain consistent with one of the approved versions. The consequence is that any content added for Pakistan must be a supplement, not a substitution. The approved label is the fixed text; what Pakistan permits is the addition of its own mandatory elements around that text, never the rewriting of it. Teams accustomed to markets where local artwork can be freely composed need to reset their instincts at this border: the creative freedom lies in what is added, not in what is already there.

Insight two: Rule 14(6) stands in a pair of tension with Rule 24(b). Rule 24(b) requires the label to carry the information of the authorised representative within Pakistan, while Rule 14(6) requires the label to match the reference-country approved version. The working resolution is to apply the representative information as a supplementary label, without rewriting the substantive content of the original approved label. The two rules were plainly both intended to apply, and the supplement method lets them apply at once: the approved text stands unaltered where the reference regulator can still recognise it, and the Pakistani additions sit beside it where the local inspector can find them.

Insight three: the rule also explains why maintaining the reference-country approval matters so much. Once the reference-country approved version is updated, through a renewed CE certificate or a revision of the instructions for use, the Pakistani labelling position must follow in step. Any change on the reference-country side transmits directly into Pakistan. The label is thus chained, through the consistency duty, to a foreign approval lifecycle that the Pakistani holder does not control, and the only defence is vigilance: watching the reference side for changes and treating each one as the opening of a Pakistani label review rather than as a foreign event with no local consequence.

4. Practical recommendations

• The working method for Pakistani labels is: first lock the original text of the reference-country approved version, then overlay the Pakistani mandatory items on it, such as the representative information and the enlistment or registration number.
• Before every label revision, re-verify whether the reference-country approved version has changed.
• The key discipline is: do not alter the substantive information of the approved version for the sake of localisation.
• Keep a record of label versions and effective dates so that each revision can be traced to the approved version it preserves and the change that prompted it.

5. Verification checklist

• □ Original text of the reference-country approved label and instructions obtained and locked
• □ Pakistani mandatory items applied as a supplementary label
• □ Substantive information of the approved version left unaltered
• □ Pakistani label re-checked in step with reference-country approval updates
• □ Label versions and effective dates recorded
• □ Rule 24(b) representative information shown on the label

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