Pakistan Form-7A: Class B/C/D Registration Application Requirements

1. Key takeaways

Imported Class B/C/D devices in Pakistan follow the registration route and use the Form-7A application. In addition to the authorisation letter and FSC required for Class A, the registration route must also provide quality management system certification (ISO 13485 / GMP) and evidence of conformity (a CE certificate or FDA licence); Class D additionally requires a design examination certificate. The practical consequence is that a Class B/C/D dossier is assembled from two layers — the entity and source documents shared with enlistment, and the device-specific quality and conformity evidence that only the registration route demands.

• Class B/C/D goes through registration, filed on Form-7A, under Rule 13(1)(b) and Rule 14(2)(b) of the Medical Devices Rules, 2017.
• Beyond the shared authorisation letter and FSC, the dossier must include ISO 13485 or GMP certification and conformity evidence — a CE certificate or an FDA licence.
• Class D carries one extra document: the design examination certificate, which must not be forgotten in dossier assembly.
• Certificates enter the register and registration numbers are issued on Form-8 / 8A, valid for 5 years; rejection must be given with written reasons.
• Labelling is bound to approved versions by Rule 14(6), which shapes how any Pakistan-specific label work must be handled.

2. Legal basis

The registration route for Class B/C/D is defined across Rules 13 to 15 of the Medical Devices Rules, 2017 (notified 2018-01-16), with fees set out in Schedule C under rule 63. The fee figures below come from registration practice compilation and should be confirmed against the current Schedule C at payment time.

3. Expert insights

Insight one: the difference between B/C/D and A is not whether the file is reviewed, but how deeply. The intake checks (fees and material completeness) are the same set for both routes; the difference is that the registration route requires additional QMS and conformity evidence, and the depth of evaluation is higher. This framing helps clients budget correctly: the incremental cost of moving from Class A to Class B is not mostly administrative, it is the cost of producing and maintaining the quality system and conformity certificates that the deeper review reads.

Insight two: Rule 14(6) is the hardest technical constraint in the registration route. The provision requires the device’s complete labels and prescription information to be consistent with the version approved in the country of origin, or with the versions approved by the EU, the United States, Japan, Canada or Australia. This means a separate label cannot simply be redesigned for the Pakistani market. Any wording, claim or specification that diverges from an approved reference version is not a labelling preference question — it is a conformity question, and it must be resolved through the regulatory change process rather than through marketing edits.

Insight three: Rule 15 places the premises inspection and the certificate in the same provision. The text provides that the MDB may inspect premises and constitute an expert panel (including inspectors or auditors), and that once the conditions are met the device is entered into the register and a certificate issued. The inspection is a preceding option for issuance, not a spot check that follows issuance. For sponsors, this means the premises readiness work described for the Establishment Licence can also surface inside the product registration timeline, and both tracks should be planned with that possibility in view rather than assuming inspection belongs only to the licence stage.

4. Practical recommendations

When GRZAN prepares a Form-7A dossier, the first exercise performed is a label consistency check: the proposed Pakistani label is compared field by field against the approved version in the country of origin or the reference country.

• Run the label consistency check before anything else: compare every field of the proposed Pakistani label with the approved version in the country of origin or the reference country.
• Where any inconsistency appears, the correct response is not to edit the label but to go back to the registration documentation and determine whether a change procedure should be initiated.
• Confirm the class assignment before assembly: Class B/C/D applies Form-7A, and a mis-classified filing triggers the wrong form and the wrong fee category.
• Verify that the ISO 13485 or GMP certificate and the CE certificate or FDA licence are current, since expired certificates defeat the purpose of attaching them.
• For Class D specifically, locate and attach the EC design examination certificate early — it is the document most often discovered missing at the last minute.
• Treat Rule 14(6) as more rigid in Pakistan than in other markets, because it is written directly into the provision itself.

5. Verification checklist

• □ Confirmed the class is B/C/D and Form-7A applies
• □ The manufacturer authorisation notarised in the country of origin has been attached
• □ A notarised FSC has been attached
• □ An ISO 13485 certificate or GMP evidence has been attached
• □ A CE certificate or FDA licence letter has been attached
• □ Class D: the EC design examination certificate has been attached
• □ The label has been checked for consistency with the approved version in the country of origin or the reference country

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