Pakistan Inspection Exemption: How Rule 15(2) Waives Premises Inspection

1. Key takeaways

Rule 15(1) of the Medical Devices Rules, 2017 provides that after accepting an application the MDB may inspect the premises of the establishment, for which it may constitute a panel of experts (which may comprise inspectors or auditors); but in cases falling under the countries specified in Rule 15(2), that inspection shall be exempt. This means reference-country approval is the statutory basis for exemption from the on-site inspection. The provision pairs an inspecting power with a precisely worded carve-out, and the carve-out is what foreign sponsors with listed approvals build their Pakistan strategy on. Reading the two sentences together is the whole exercise: the power exists, it is real, and it is exercised through a structured panel — but its reach stops exactly at the border drawn by the sub-rule that follows, and every filing decision should be made with that boundary in clear view.

• The MDB holds a general power to inspect establishment premises, exercised through a panel of experts that may include inspectors or auditors.
• The same provision exempts cases from the countries specified in Rule 15(2) — making the exemption country-based by its very wording.
• The exemption covers the premises inspection only; other verification measures in MDR 2017 remain in force.
• For foreign manufacturers, reference-country approval solves two problems at once: no on-site inspection and a compressed administrative timeline.

2. Legal basis

The inspection power and its exemption, the reference-country list and the two additional reliance routes, and the certificate mechanics that follow, are all contained within Rule 15 of the Medical Devices Rules, 2017 (notified 2018-01-16). The table below maps each element to its sub-rule; note that the exemption is anchored in the final sentence of Rule 15(1).

3. Expert insights

Insight one: the exemption is set by country, not by product. The operative words of the provision are the countries as specified under sub-rule (2) — the test is which country the approval comes from, not the risk level of the product itself. This drafting choice makes the outcome predictable at the pathway-selection stage: a sponsor can read the list, look at its own certificates and know with certainty whether the exemption is available, without waiting for a discretionary judgement from the authority. It also means the exemption cannot be earned by product virtues; a brilliant dossier cannot substitute for a listed approval here.

Insight two: the exemption does not exclude other verification measures. Rule 15(1) exempts only the premises inspection, while other provisions of MDR 2017 retain measures such as sampling and analysis. An exemption from the factory audit is not an exemption from technical review. Sponsors sometimes read the carve-out more broadly than its text supports, and the error surfaces later when sampling or documentation queries arrive on the normal schedule. Correct scoping of the exemption — premises inspection in, everything else unchanged — should be recorded in the project file so downstream teams plan around the real rule rather than an enlarged one. Teams that scope it correctly allocate their preparation effort where it actually counts: on the technical dossier, not on rehearsing for an inspection that will never happen.

Insight three: for foreign manufacturers, reference-country approval solves two problems at once. First, it removes the on-site inspection; second, it compresses the administrative processing timeline. In Pakistan, the practical value of reference-country approval is far higher than a bonus item. It is a structural advantage that reshapes the entire project: no audit preparation, no hosting risk, no scheduling dependency on a foreign inspection team, and a shorter route to the certificate. Sponsors holding a listed approval should treat it as the centrepiece of their Pakistan market entry plan rather than one factor among many, and sponsors without one should treat obtaining it as the highest-value upstream investment available to them, because everything downstream becomes easier once it exists.

4. Practical recommendations

At the project evaluation stage, GRZAN treats the question of whether a usable reference-country approval exists as the watershed: if yes, the project is scheduled on the abridged pathway; if no, the discussion turns first to building a route or changing the classification.

• Make the reference-approval question the first gate of project evaluation, before timelines or budgets are drafted, because it determines which pathway everything else follows.
• With a usable approval, schedule the project on the abridged pathway and record the exemption basis in the dossier.
• Without one, discuss either building a reference-country route or reassessing the classification before committing to a standard-route filing.
• GRZAN does not recommend clients submit Class C/D in a no-reference-approval state with a try-it-and-see mindset, because the cost of one return is months of time plus the official fees.
• Scope the exemption correctly in all project documents — premises inspection only — so sampling and technical review expectations stay accurate.

5. Verification checklist

• □ Confirmed whether the country of the reference-country approval evidence falls within the Rule 15(2) list
• □ Assessed whether the premises inspection exemption can apply
• □ Confirmed the exemption does not cover technical documentation and sampling requirements
• □ The exemption basis has been written onto the first page of the project dossier
• □ The validity period of the reference-country certificates has been entered on the maintenance list

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