Pakistan: Enlistment versus Registration Fee Differences for Medical Devices

1. Key takeaways

Pakistan’s fee ladder corresponds directly to two pathways: Class A goes through enlistment, while Class B/C/D go through registration, and the fee standards for the two differ; the renewal fee is usually 50% of the initial fee or equal to it, depending on the specific entry in Schedule C. The higher the class, the higher both the initial fee and the renewal fee rise together — this is the direct reason to review registration planning and cash flow side by side.

For a portfolio entry rather than a single-product entry, the consequence is that the fee position is shaped as much by product classification as by product count. Two portfolios of identical size can carry very different five-year fee totals depending on where the Class A / Class B boundary falls and how the certificates are grouped under Schedule B. Reading the fee ladder correctly at the planning stage therefore protects the budget throughout the certificate life, not just at the first filing. It also prevents the reverse mistake of over-provisioning for Class A items as if they carried registration-level fees, which ties up cash that the project could use elsewhere.

2. Legal basis

The table below sets out the provisions governing the two pathways, the applicable forms, and the fee rules that drive the ladder.

Because the fee entries sit inside Schedule C and the schedule is amended by S.R.O., the working rule is to verify every amount against the schedule in force on the filing date, and to treat any figure quoted from memory or from an older document as provisional until it has been re-checked. The same discipline applies to the change-fee note: because it is expressed as a percentage of the relevant fee, the note only becomes a concrete number once the underlying fee for that certificate has been confirmed from the current schedule.

3. Expert insights

Insight 1: cheap enlistment does not mean simple enlistment. The enlistment fee for Class A is indeed lower than the registration fee for Class B/C/D, but enlistment still requires the establishment licence to be obtained first, and still requires Form-6A with its supporting documents to be submitted. Reading enlistment as an exemption from review is a common misinterpretation. The correct reading is that enlistment is a lighter and less expensive pathway, not a doorway without requirements: the applicant eligibility rules, the accompanying fees, and the portal procedures apply with full force. Companies that planned around the lighter pathway without budgeting for the entity-level licence have found the sequence stalls at the first step, since the enlistment application cannot proceed without the establishment licence underneath it.

Insight 2: the renewal fee ratio is by design, not random. The initial fee covers the full review effort, while renewal is mainly a matter of maintaining status (in Schedule C, the renewal fee is mostly 50% of the initial fee or equal to it, depending on the entry). This means the renewal budget can be estimated precisely, and there is no need to provision at the scale of the initial filing. For finance teams this is one of the friendlier features of the Pakistani system: the largest and least predictable cost — the first review — occurs once, and everything after it follows a known ratio that can be placed in the budget years in advance. The precision also cuts both ways, since an overstated renewal provision is just as visible in the model as an understated one.

Insight 3: within one product portfolio, mixed classes can change the total fee significantly. A system or a kit that spans Class A and Class B cannot be billed at a single class. When we plan Schedule B grouping, we work the fee tiers into the analysis at the same time, to keep quotations from going off target. Grouping decisions made purely on documentation convenience can quietly multiply the number of fee-bearing certificates across the portfolio, so the grouping proposal and the fee model should be reviewed together before they are locked in. Where a portfolio is still being finalised, running the fee model under two or three grouping scenarios is a cheap exercise that prevents the most expensive kind of surprise.

4. Practical recommendations

In GRZAN’s quotation template, the fee column is always written as an explanation of the product of three variables — class × grouping × cycle — rather than a single lump number. The class determines the unit price, the grouping determines the number of certificates, and the cycle determines the number of renewals. Once these three variables are written into the contract, both parties have a firm basis to fall back on, whatever adjustments the rules undergo later. The same three variables should therefore also drive the internal budget model from day one, so a change in classification or grouping immediately shows its cost consequence in the model. We also recommend stating in the contract that fees follow the Schedule C version in force at each filing, which removes any dispute if the schedule is amended mid-project. Finally, the quotation should identify which fees are DRAP charges and which are service costs, so the client can see that the statutory amounts pass through untouched.

5. Verification checklist

• □ Initial fees checked separately for Class A / B / C / D
• □ Corresponding renewal fees checked
• □ Effect of product grouping (Schedule B) on the number of certificates confirmed
• □ The three variables — class, grouping, cycle — stated in the quotation
• □ Noted that fees follow the current Schedule C and the portal challan

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