Pakistan Medical Device Registration Fees under Schedule C in PKR

1. Key takeaways

Medical device fees in Pakistan are not subject to negotiation; they are charged uniformly under Schedule C of the Medical Devices Rules, 2017, with the legal basis in Rule 63. The fees fall roughly into four blocks: establishment licences, product enlistment/registration, import permits, and post-enlistment/post-registration changes. All fees are denominated in Pakistani rupees (PKR), and payment is made at designated banks after the challan (payment slip) is generated through the portal. Certificates and licences are all valid for 5 years, so fee planning should be done on a five-year cycle.

The practical message for budgeting is that Pakistan’s fee system is predictable but multi-layered. Because the amounts are fixed by the schedule rather than set case by case, a finance team can build an exact five-year cost model once the product classification and entity structure are known. The risk lies not in unknown prices but in missed triggers: a variation filed late, a renewal date overlooked, or an import permit fee left out of the plan. Each of these is an administrative event with a known price, which makes them all the more inexcusable when they are missed. A complete fee map drawn from Schedule C closes those gaps before they become cash-flow surprises. It also gives management a defensible number when the market-entry plan is presented, instead of a rough figure that has to be corrected later.

2. Legal basis

The table below collects the provisions and references that govern how device fees are charged and paid in Pakistan.

Note that the fee schedule is a living instrument: it has already been amended by S.R.O. 1399(I)/2025 with effect from 1 August 2025, so every budget should be checked against the schedule in force at the time of filing rather than copied from an older file. In our workflow, the schedule check is a standing step at the start of each filing cycle: the client’s fee table is re-validated line by line against the current text, and any movement is flagged to finance before the application is submitted, not after the challan arrives.

3. Expert insights

Insight 1: split the fees into an entity line and a product line before the accounts will add up. The entity line is the establishment licence (import 20,000 PKR / renewal 10,000 PKR); the product line is the enlistment or registration fee, plus the import permit (5,000 PKR). Every new product entering the market passes through at least three fee gates. Teams that budget only for the product fee routinely undercount by the entity fee and the import permit fee, which is exactly the kind of omission a five-year table is designed to catch. The three gates should be entered as three separate line items, each with its own trigger, so that nothing disappears inside a lump sum.

Insight 2: the risk class determines the product fee tier. Class A goes through enlistment, Class B and Class C/D go through registration, and the fees rise with the risk class. This ladder is the design logic of Schedule C — the higher the risk, the greater the review effort, and the higher the fee. The corollary for planning is that classification decisions taken early in the project — including how a product family is grouped — feed directly into the total fee position, so classification and budgeting should be handled together rather than by separate teams on separate timelines.

Insight 3: changes are not free, and the ratio follows a rule. Post-enlistment and post-registration changes are charged separately under Schedule C, and general changes are charged at 50% of the relevant fee. The 50% ratio is given in the provisions; it is not an estimate. This matters because changes are frequent over a five-year certificate life — address updates, standard version updates, label revisions — and each one carries its own fee line. A budget that ignores variation fees will be systematically short in the middle years of the cycle. Because the ratio is fixed, however, the exposure is at least calculable: once the relevant fee for a certificate is known, the cost of a general change follows mechanically, and only the number of changes has to be estimated.

4. Practical recommendations

GRZAN prepares for its clients a “five-year full-cycle fee table”: the horizontal axis is the year, and the vertical axis lists five line items — entity licence fees, product fees, import permit fees, variation fees, and renewal fees. Each line item is marked with its amount and its trigger condition, so finance can see at a glance which year carries the heaviest cash-flow pressure. One particular reminder: both the establishment licence and the product certificates run for 5 years, but if they were obtained in different batches, the renewal years will be staggered, so the budget table must be laid out item by item according to the actual issuance dates. We also recommend re-running the table whenever a new S.R.O. amends Schedule C, since the fee base itself can move between cycles. Finally, the table should be shared with the regulatory team and not kept within finance alone: most fee triggers — a change, a renewal, a fresh import permit — are set in motion by regulatory activity, and the people initiating that activity need to see the cost consequences of each filing.

5. Verification checklist

• □ Amounts checked item by item against the current Schedule C (including the S.R.O. 1399(I)/2025 amendments)
• □ Entity licence fees distinguished from product enlistment/registration fees
• □ Import permit fee included
• □ Variation fees provisioned (general changes at 50% of the relevant fee)
• □ Renewal years scheduled according to the 5-year validity periods

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