Pakistan Form-6A: Class A Enlistment Application for Imported Devices

1. Key takeaways

Imported Class A devices in Pakistan follow the enlistment route and use the Form-6A application. The applicant must be an importer holding a valid Establishment Licence (acting in the capacity of an authorised representative), and must attach the fee prescribed under rule 63 together with the particulars, documents or samples required by Form-6A. The format of Form-6A was amended in 2022 through S.R.O. 430(I)/2022, and the current version must be used at submission. Three points follow from this opening position. Eligibility is licence-based, so the entity milestone discussed elsewhere in this series sits in front of every Class A filing. Completeness is checked at intake under a rule that applies to every route, whatever the risk class. And form version control is a live failure point that has already been settled by a 2022 amendment — meaning any filing prepared on a stored, pre-amendment copy of the form is out of compliance before DRAP reads a single line of it.

• Class A goes through enlistment, a distinct statutory route with its own form, Form-6A, not a simplified variant of the registration track.
• Only an importer holding a valid Establishment Licence, acting as authorised representative, may file the Form-6A application.
• The application must carry the rule 63 fee plus the particulars, documents or samples listed in Form-6A; incomplete applications can be returned.
• Form-6A was amended by S.R.O. 430(I)/2022 in 2022 — filing an outdated version is a rejection risk that is entirely avoidable by checking the portal before submission.

2. Legal basis

The enlistment route, the form used for imported Class A devices, the completeness and fee requirements, and the amendment history of Form-6A are all traceable to the Medical Devices Rules, 2017 and the 2022 statutory regulatory order. The fee amounts in the table are drawn from registration practice compilation and should always be confirmed against the current Schedule C before payment.

3. Expert insights

Insight one: enlistment for Class A is an independent statutory type, not a simplified registration. Rule 13(1) places it alongside the registration track for B/C/D, each with its own corresponding form (Form-6A versus Form-7A). In the text of the rules the two are parallel institutions, not two tiers of the same system. This distinction matters when advising clients: describing Class A enlistment as a light registration understates the discipline the intake rules actually impose on the filing. It also matters for portfolio planning, because a sponsor cannot assume that lessons, templates or fee assumptions carried over from a registration project will transfer unchanged to an enlistment project — the forms differ, the fee categories differ, and the terminology used on the portal differs as well.

Insight two: the enlistment route is also subject to the completeness check. Rule 14(3)–(4) applies to both routes alike: where fees are unpaid or materials are incomplete, the MDB may return the application directly. So low risk does not mean low requirements. The intake gate is mechanical and unforgiving — it reads the fee receipt and the attachment list, not the risk class of the device. Sponsors who treat Class A casually because the device is low-risk are the ones who meet Rule 14(4) in the worst way, through a returned application.

Insight three: form version is the most common return point in practice. Form-6A was amended in 2022. Applications filed on the old version of the form are treated as non-compliant with the format requirements, and since the paper submission channel ceased to be accepted from 21 July 2025, version checking must be completed before submission — there is no offline fallback in which an old form can be quietly corrected. The check takes minutes on the DRAP portal; the cost of skipping it is an entire filing cycle. The lesson generalises: every DRAP form used in a Pakistan project should be pulled fresh from the portal at filing time, never from a local archive, because the portal is the single authoritative source of what the authority will accept.

4. Practical recommendations

GRZAN follows a fixed three-step discipline before any Form-6A goes out, precisely because the return reasons at this stage are administrative rather than scientific.

• First, obtain the current version of the form and the checklist from the local partner’s DRAP portal account, so the filing is built on the live template rather than a stored copy.
• Second, tick every item on the checklist one by one and retain the record, so completeness is demonstrated before submission rather than discovered after a return.
• Third, confirm the fee amount matches the enlistment category — enlistment and registration fees differ (see the fees guidance), and a misrouted payment is itself a return trigger.
• Only after all three steps are complete is the application formally submitted — because once formally submitted and paid, the draft is locked as a non-editable version.
• Keep the manufacturer authorisation from the country of origin notarised, and attach either a notarised FSC or a notarised DoC, as the checklist requires.

5. Verification checklist

• □ The current version of Form-6A has been adopted
• □ The applicant’s Establishment Licence is valid
• □ The manufacturer authorisation notarised in the country of origin has been attached
• □ A notarised FSC or a notarised DoC has been attached (either one)
• □ The fee amount matches the enlistment category
• □ The portal completeness check has been completed before formal submission

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