Pakistan Form-6A and Form-7A Dossier Checklist

1. Key takeaways

The regulatory dossier for imported medical devices in Pakistan is governed by two statutory forms: Form-6A applies to Class A devices, while Form-7A applies to Class B, C and D devices. The core materials that make up the dossier include the application form itself, detailed information on the importer and the manufacturer, a letter of authorization notarized in the country of origin, a Free Sale Certificate (FSC) attested by the Pakistani embassy in that country, a quality management system certificate (ISO 13485 or GMP), the Essential Principles of Safety and Performance, the Declaration of Conformity (DoC), and the technical documentation. Rule 14(3) of the Medical Devices Rules 2017 states the principle explicitly: an application must be accompanied at the same time by the fee prescribed under rule 63 and by the information, documents and samples specified in the form. In other words, the forms are not merely administrative covers; they define the complete scope of what the regulator expects to receive, and every element listed above must be traceable to a field or attachment inside the chosen form.

• The form is selected strictly by risk class: Form-6A for imported Class A devices and Form-7A for imported Class B, C and D devices, each in the version currently in force.
• The fee is not optional or separate from the dossier; under Rule 14(3) it travels with the application and is prescribed under Rule 63 and Schedule C.
• Information, documents and samples are required as set out in the form itself, with the statutory qualifier “where practicable” attached to samples.
• An application that lacks the fee, or lacks the required information, documents or samples, is exposed to return under Rule 14(4).
• Manufacturing methods and testing methods must conform to the principles of verification.
• The complete label and the prescribing information must match the approved version of the country of origin or the reference country.
• Product grouping under Schedule B determines how many forms and how many fees a portfolio will generate.

2. Legal basis

The table below consolidates the statutory anchors for the imported-device dossier under the Medical Devices Rules 2017, notified on 16 January 2018. Each requirement in the takeaways above maps to one of these provisions, and the mapping is worth preserving in the dossier index so that reviewers can move from any document to its legal basis without guesswork.

3. Expert insights

Insight one: Rule 14(3) carries a qualifier that is easy to overlook, namely “where practicable”. When the provision lists what an application must include, the requirement to submit samples is expressly softened with this phrase, meaning that samples are not an absolute element of the dossier, but they will be demanded whenever the reviewing authority considers it practicable to demand them. This single drafting choice explains why, in day-to-day practice, sample expectations are not uniform across products. Two dossiers filed in the same period, for devices of the same class, may face different sample requests, and the difference is not arbitrariness but the exercise of the discretion embedded in the wording. Applicants who treat the sample line as conditional from the outset, and who document a reasoned position on practicability, are far better placed to respond when a request actually arrives.

Insight two: the fee and the materials are verified as one package, and a deficiency in either is grounds for return. Rule 14(4) places “fee not paid” and “information not provided” side by side as parallel grounds for returning an application. The payment receipt and the complete document set must therefore be in place simultaneously; one without the other does not start the clock. This joint verification also explains the behaviour of the submission portal, which opens the upload fields only after the fee has been paid. The system design mirrors the legal design: paying and submitting are one act, not two, and planning them as separate milestones invites a return notice.

Insight three: product grouping is the multiplier of both fees and workload. Schedule B defines six ways of grouping products: the single device, the device family, the system, the set, the in vitro diagnostic test kit, and the in vitro diagnostic device cluster. The chosen grouping determines how many forms must be filed and how many fees must be paid, and it should be planned immediately after the classification of the device is settled. A portfolio that could be filed as a family, but is instead filed device by device, pays the price many times over, while an over-broad grouping risks rejection. Grouping is therefore a costing decision as much as a regulatory one.

4. Practical recommendations

• Build every Pakistan project on a one-form, one-checklist discipline: use Form-6A or Form-7A as the skeleton, and map each requirement of the form to a specific document number and version.
• Reserve three columns in the checklist for every line item: whether the document needs notarization, whether it needs embassy attestation, and whether it carries an expiry date.
• Once the three columns are filled in, the workload of the entire attestation chain is quantified, and the project schedule can be planned on evidence instead of instinct.
• Update the checklist whenever the class, the grouping or the product scope changes, because each of these changes propagates into the form, the fee and the attestation chain.
• Keep the payment step and the document assembly step inside one milestone, reflecting the joint-verification logic of Rule 14(3) and Rule 14(4).

5. Verification checklist

• □ Form-6A or Form-7A selected according to the device class, in the current version
• □ Importer and manufacturer information completed in full
• □ Letter of authorization notarized in the country of origin
• □ FSC attested by the Pakistani embassy (two certificates for Class C/D)
• □ ISO 13485 or GMP certificate prepared and within its validity period
• □ Essential Principles and the DoC prepared
• □ Label artwork completed and cross-checked against the approved version
• □ Product grouping approach determined

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