Pakistan Medical Device Registration: Roles and Certificate Structure

1. Key takeaways

Device registration in Pakistan involves four roles: the foreign manufacturer (providing technical and quality evidence), the importer / authorised representative (AR) (who must hold a valid establishment licence and is the statutory applicant), the certificate holder (the holder of the enlistment or registration certificate and its number), and the distributor (the party actually engaged in commercial sales). On the import path, the importer and the authorised representative are the same entity, and it is the only entity that can file as applicant with DRAP. For a foreign manufacturer entering the market, understanding this mapping is the first planning task: it decides who signs what, in which order, and which commercial risks can be engineered away through agreements rather than accepted as fixed costs of the regulatory design. Companies that discover the role structure late in project planning tend to rebuild their distribution strategy under time pressure, which is exactly when unfavourable terms slip into agreements unnoticed.

• Four commercial roles collapse onto two certificates in the Pakistani system.
• The establishment licence is an entity qualification; the product certificate is separate from it.
• The holder–distributor split is achieved by agreement, not by licence.
• The establishment licence must be scheduled before any product filing.

2. Legal basis

The table below anchors each role and step to its provision, from applicant eligibility through to the establishment licence system. The provisions cover both applicant identities, both form families, the labelling linkage, the reviewing body and the fee-side licence regime, so together they frame the entire role architecture described in this article.

3. Expert insights

Insight 1: The four roles in Pakistan correspond to only “two certificates”. One is the establishment licence (entity qualification, for an importer or a local manufacturer); the other is the product enlistment or registration certificate (Form-8 or Form-8A). The distinction between the certificate holder and the distributor is achieved through agreements, not through licences — this is the key leverage point of the structural design. Because no third certificate separates the commercial function from the regulatory function, the separation must be manufactured privately, in the text of the agreements between the parties. Where those agreements are silent, the roles fuse in fact, and the manufacturer’s control over its own product erodes accordingly. The lesson is that the two-certificate design is not a defect to complain about but a structure to work with: once the certificate map is understood, the agreement map follows it naturally, and every commercial right the manufacturer wants should be traceable to one of the two certificates or to the relationships around them.

Insight 2: The establishment licence is a precondition of the product filing. Rule 14(1) wrote “holding a valid establishment licence” into the applicant eligibility. Without it, no matter how complete the product materials are, the application will not be accepted. In scheduling, the establishment licence must come before the product application. This ordering is not a preference but a hard gate: a dossier that arrives without a licensed applicant behind it has nowhere to sit in the system, so the licence workstream can never be treated as parallel in the strict sense — it can only be accelerated. Practical planning therefore starts the licence process as the first calendar item and builds the dossier schedule around its expected issue date, rather than pretending both workstreams can simply start together.

Insight 3: Compared with Bangladesh and India, Pakistan’s certificate structure relies more on agreement design. Bangladesh has the NOC mechanism and India has the authorised agent (AIA) mechanism; Pakistan’s rules contain no additional “batch-by-batch consent” step, so commercial control depends entirely on how the agency agreement is written. This is both an opportunity and a warning: the absence of a statutory batch gate means nothing automatically protects the manufacturer between shipments, and equally nothing constrains it, so the allocation of rights lives entirely in the contract. Teams experienced in Bangladesh NOC practice or Indian AIA practice should consciously translate that experience into contract drafting when moving to Pakistan, because the protections they are used to receiving from the regulator now have to be built by the lawyers instead.

4. Practical recommendations

• The GRZAN standard agency agreement template for Pakistan contains six items: access rights to the registration dossier; the duty to notify changes; the division of labour on complaints and vigilance; ownership of renewal work; the certificate transfer clause when the relationship ends; and the definition of exclusive versus non-exclusive sales scope.
• We particularly emphasise the sixth item — in Pakistan, once the sales scope is written as exclusive and the certificate holder is also the distributor, the manufacturer’s exit route is closed by its own hand.
• Each clause is mapped to its statutory anchor (Rule 14(1), Rule 24(b), Rule 15), so the agreement tracks the rules rather than floating above them.
• The six items are reviewed before signature, not retrofitted after a dispute.
• Distributor appointments are kept separate from the certificate-holding agreement, preserving the holder–distributor split.

5. Verification checklist

• □ Clarified the four roles: manufacturer, importer / AR, certificate holder, distributor
• □ Confirmed the importer holds a valid establishment licence
• □ The agency agreement contains the six standard clauses
• □ Exclusive / non-exclusive sales scope is clearly defined
• □ The establishment licence is arranged before the product application
• □ 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