Pakistan Medical Device Classification: Class A, B, C and D

1. Key takeaways

Pakistan classifies medical devices into four grades: Class A (low risk), Class B (medium-low risk), Class C (medium-high risk) and Class D (high risk). The classification principles are aligned with the guidance of the GHTF (Global Harmonization Task Force) and the AHWP (Asian Harmonization Working Party). Classification is determined jointly by intended use, duration of contact, degree of invasiveness, whether the device is active, and the consequences of failure, and it directly determines both the submission route and the depth of the technical, clinical and quality system evidence. In other words, classification is the single decision from which every later cost in the project flows: the form used, the fee paid, the evidence assembled and even the grouping strategy all inherit their shape from the class assigned at this stage. A foreign manufacturer entering Pakistan should therefore treat classification as a formal deliverable with named owners and a written record, never as an assumption carried over from another market.

• Class A follows enlistment; Classes B, C and D follow registration.
• The five classification dimensions must all be assessed, not only intended use and invasiveness.
• Product grouping under Schedule B shapes how many forms and fees a portfolio requires.
• A simplified route is available where reference-country approvals exist.

2. Legal basis

The table below sets out the classification-related provisions and their sources, from the four-grade structure down to the grouping rules that determine filing economics. The alignment with GHTF and AHWP means teams familiar with those frameworks will recognise the logic, but recognition is not a substitute for verification against the Pakistani text and the DRAP device classification page.

3. Expert insights

Insight 1: Classification is not a form-filling item; it is the foundation of the entire submission. Because Class A and Classes B/C/D go through different forms (Form-6A and Form-7A) and different depths of review, one wrong step in classification makes everything after it wrong. This is the most common cause of rework in Pakistan projects. The error is rarely discovered at filing; it is discovered when the reviewer questions the evidence depth, or when the fee calculation does not match the form, at which point the dossier must be rebuilt rather than patched. Treating classification as a one-minute administrative choice at the start of a project is the most expensive mistake a team can make in this market. The rework it causes is rarely limited to one document: the forms, the fee schedule, the evidence plan and the grouping all have to be redone in sequence, and the project calendar absorbs the delay at every step.

Insight 2: Of the five classification dimensions, the consequences of failure are the most easily overlooked. Companies usually judge by “use” and “invasiveness”, but Pakistan’s rules list what happens if the device fails as an independent dimension. An intensive-care monitor and a home blood-pressure monitor, even with similar technical complexity, may fall into different classes. Teams that copy a classification from another market without re-running the failure-consequence analysis against the Pakistani rules take a silent risk, because the dimension weighting can differ and the resulting class determines both the form and the evidence burden. The failure-consequence question should be answered in writing for every product, describing what happens to the patient when the device stops working, and that answer belongs in the classification record reviewed before drafting begins.

Insight 3: Product grouping (Schedule B) can materially affect cost and timeline. A single family, system, set or IVD cluster can be filed together, and the grouping choice determines how many forms must be submitted and how many fees must be paid. Grouping planning should start immediately after classification is settled, not after the dossier is written. Leaving grouping until the end means the dossier structure may have to be rearranged, certificates may be split in ways that complicate import paperwork, and the fee total may rise without any regulatory benefit. For a multi-product portfolio, the grouping review is repeated across every product line, because a decision that saves fees on one family may create certificate fragmentation on another; the whole portfolio, not each item separately, is the correct unit of planning.

4. Practical recommendations

• As the first step in a Pakistan project, GRZAN issues a written classification opinion.
• The opinion states: which class the product falls into, which classification rule it relies on, how combination components are handled, and which Schedule B grouping approach is recommended.
• The opinion is sent to both the client and the local partner and serves as the common baseline for subsequent dossier preparation.
• For products whose classification is in doubt, we recommend that the local partner formally submit a Classification Request to MDMC rather than reaching a private conclusion.
• Grouping decisions are documented together with the classification opinion, so that the number of forms and fees can be budgeted before drafting begins.
• Where the simplified route under Rule 15(2) is in play, the reference-country approval evidence is confirmed as available before the grouping plan is finalised.

5. Verification checklist

• □ Judged on all five dimensions: intended use, contact duration, invasiveness, active status, consequences of failure
• □ A written classification opinion has been prepared and retained
• □ The Schedule B product grouping approach has been determined
• □ Combination devices have been handled at the highest risk grade involved
• □ For doubtful classifications, a Classification Request to MDMC has been arranged

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