Pakistan Standard Evaluation Pathway: Class B/C/D Without Reference Approvals

1. Key takeaways

Class B/C/D devices without approval from a reference regulatory authority cannot use the abridged pathway and must follow the Standard Evaluation Pathway: technical documentation, quality system and clinical / performance evidence are submitted under the complete requirements, and both the depth of evaluation and the number of deficiency round-trips rise markedly. Registration practice compilation generally does not recommend filing Class C/D without reference-country approval. The pathway is not punitive by design — it is simply the full review, applied in full, to every file that cannot borrow an external regulatory conclusion. Sponsors entering this route should do so with open eyes: the evidence burden is heavier, the calendar is less predictable, and the review conversation runs longer than anything the abridged pathway requires of a comparable product.

• The abridged pathway’s precondition is an existing reference-country approval; without one, the standard route applies by default.
• The standard route requires the complete evidence set — technical documentation, quality system and clinical / performance evidence — at full depth.
• Deficiency round-trips become the main variable in the timeline, and their number cannot be tightly predicted in advance.
• No simplification exists for low perceived risk: the exemption framework is country-based, not risk-based.
• The timeline figures for this route come from registration practice compilation and are marked as a practical estimate, pending verification.

2. Legal basis

The standard pathway is not defined by a dedicated provision; it is what remains once the Rule 15(2) reliance route is unavailable. The relevant anchors are the completeness and return rules, the validation principles and the country-limited exemption. The timeline row in the table is deliberately labelled as an estimate from registration practice compilation, pending verification.

3. Expert insights

Insight one: the cost of the standard route is a double rise — in evidence volume and in review rounds. Without reference-country approval, the MDB cannot rely on an external conclusion and must review the entire technical evidence itself. Deficiency round-trips become the main variable in the timeline. Each round adds elapsed time that is not fully controllable by the applicant, because it depends on how the reviewing team reads the file and how many issues surface per round. A dossier that anticipates those reads before submission compresses the rounds; one that assumes the reviewer will ask nothing extends them. This is also why the standard route punishes haste more visibly than any other track in the Pakistan framework: the time lost to avoidable round-trips is typically far greater than the time invested in preparing the file properly at the start.

Insight two: the rules create no simplified opening for products without reference-country approval. The exemption in Rule 15(2) is enumerated country by country, not judged by whether a product is low risk. This means that even a medium-risk product, if it comes from outside the listed jurisdictions, still undergoes the complete review. The framework is deliberately mechanical at this point: the reliance question is answered by geography and certificate origin, which keeps the authority’s treatment predictable but leaves unlisted sponsors without a discretionary shortcut to argue for. Arguments about device design, intended use or comparative safety therefore carry no procedural weight at the pathway-selection stage — they may inform the review later, but they cannot move a product onto a different track.

Insight three: the validation principles of Rule 14(5) carry more weight on the standard route. Without external endorsement, the validation records of the manufacturing methods and testing methods themselves become the core handle of the review. GRZAN recommends that such projects compile the method validation documentation into a standalone volume, so the reviewers can locate the anchor evidence quickly instead of reconstructing it from scattered dossier sections. A well-organised validation volume does not shorten the statutory depth of review, but it shortens the parts of the review that depend on finding and connecting the right documents. The same logic applies to the traceability between methods and results: a file in which every test method points cleanly to its validation record removes an entire category of questions before the reviewer can ask them.

4. Practical recommendations

For products without reference-country approval, GRZAN’s recommendation usually takes one of two forms, decided at project evaluation rather than after a failed filing attempt.

• First option: obtain market access in one reference country first — the EU CE route is the most common choice, longer in cycle but with the best reusability afterwards — and then file in Pakistan.
• Second option: reassess the product classification, to determine whether it could fall into the Class A enlistment channel instead.
• Filing Class C/D directly in a no-reference-approval state is flagged as a high-risk route at the project evaluation stage.
• Prepare the complete technical documentation and clinical / performance evidence set before submission, since partial dossiers simply convert into deficiency rounds.
• Compile the method validation documentation as a standalone volume so Rule 14(5) evidence is easy to locate and review.
• Reserve a generous time budget for deficiency round-trips, and record the route-choice rationale in the project risk assessment.

5. Verification checklist

• □ Confirmed whether reference-country approval evidence exists
• □ Projects without evidence have been assessed: obtain reference-country access first, or re-evaluate classification
• □ Complete technical documentation and clinical / performance evidence have been prepared
• □ The method validation documentation has been compiled as a standalone volume
• □ A generous time budget for deficiency round-trips has been reserved
• □ The route-choice rationale has been recorded in the project risk assessment

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