Pakistan Authorized Representative: Mandatory under Rule 14

1. Key takeaways

Foreign manufacturers cannot submit device enlistment or registration applications to DRAP by themselves. Rule 14(1) of the Medical Devices Rules, 2017 limits the applicant to two categories: (1) an institution holding a valid production licence (the local manufacturing route); and (2) an importer acting in the capacity of an authorised representative (authorized representative), who must hold a valid establishment licence. Foreign manufacturers must file through the latter and bear the corresponding legal responsibilities. In practical terms, this single eligibility rule shapes the entire commercial architecture of a Pakistan project: before a single document of the product dossier can be drafted, the manufacturer must already have identified, contracted and licensed the local entity that will put its name on the application. Choosing that entity well, and contracting around it carefully, matters as much as the technical file itself.

• There is no direct filing channel for a foreign manufacturer in Pakistan.
• The importer and the authorised representative are fused into a single identity by the rule.
• The applicant must hold a valid establishment licence before any product filing.
• The representative’s details must appear on the product label.

2. Legal basis

The table below sets out the provisions that define who may apply, on which forms, with which attachments, and what must be displayed on the label. Each row is an obligation that a well-drafted agency agreement should reference explicitly, so that contract language and statutory language stay aligned.

3. Expert insights

Insight 1: The rule fuses the “importer” and the “authorised representative” into one identity. The wording of Rule 14(1)(b) reads “an importer in his capacity as authorized representative in Pakistan having valid establishment licence” — not “an importer or an authorised representative”, but an importer acting in the capacity of authorised representative. This means that in Pakistan, the licensed entity is naturally the holder of the import channel. The drafting choice is deliberate: it ties the regulatory file to the entity that physically brings the goods into the country, so accountability for what enters the market and accountability for the registration file sit on the same pair of shoulders. Foreign manufacturers reading the clause through the lens of other markets, where a representative may be an entity separate from any importer, should correct that assumption at the outset. It also implies that the importer’s customs competence and its regulatory diligence are the same competence: a partner weak on one side is weak on both.

Insight 2: This forms a sharp contrast with Bangladesh. The practical estimate in Bangladesh is “one certificate holder per device”, and the certificate holder issues batch-by-batch NOCs; in Pakistan, the rule text makes the applicant itself the importer. The commercial risks in both countries share the same origin — the licence and the channel are unified in one hand — but in Pakistan, this structure is directly prescribed by the rules text, not merely a matter of practice. The difference matters for contracting: in Bangladesh, practice can shift; in Pakistan, the fused identity is written into the law, so no agency structure can design it away. What an agreement can do instead is redistribute the commercial powers around that fixed identity, which is exactly where the drafting effort should go.

Insight 3: Rule 24(b) puts the representative identity “on the label”. The provision requires that the local representative’s information be shown on the product label. This means the certificate holder’s details enter the market together with the product, and replacing the representative implies a label change, which in turn triggers change procedures. This is the core constraint of Pakistan’s certificate-holding structure design. A label change is not a print shop task alone: it connects to the approved version of the labelling, so the change must be carried through the regulatory channel, with timing and cost that should be anticipated in any plan to switch partners. Manufacturers should therefore treat the label as a live commercial dependency of the certificate, not a static artwork file.

4. Practical recommendations

• GRZAN’s advice matches its Bangladesh advice: separate registration from the sales channel.
• The Pakistan-specific approach: use a licensed importer that does not engage in commercial distribution as the applicant and certificate holder, and hand sales to distributors.
• The agency agreement should make three things explicit: access rights to the registration dossier; the duty to notify changes (especially the label change when the representative is replaced); and the method for transferring the registration certificate when the relationship ends.
• With these three items written clearly, the manufacturer holds the initiative in the relationship.
• The agreement is reviewed against Rule 14(1)(b) and Rule 24(b) so that every obligation in it maps to a statutory anchor.

5. Verification checklist

• □ Confirmed that foreign manufacturers cannot file directly
• □ Appointed a local importer holding a valid establishment licence as the applicant
• □ Signed an agency agreement providing dossier access rights
• □ Agreed the duty to notify changes and the handling of label changes
• □ Agreed the method for transferring the registration certificate when the relationship ends
• □ Confirmed the label shows the local representative information (Rule 24(b))

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