Pakistan Medical Device Market Entry Roadmap: The Six Steps

1. Key takeaways

From classification to holding an import device certificate in Pakistan, there are six steps: (1) determine the Class A–D classification; (2) appoint a local authorised representative (AR) holding an establishment licence; (3) obtain or verify the establishment licence; (4) prepare the dossier according to Form-6A (Class A) / Form-7A (B/C/D); (5) pay the fees and submit online through the e-Service portal; (6) once MDB review is passed, the certificate is issued on Form-8A (import), valid for 5 years. Each step consumes the output of the one before it, so the roadmap works only when the steps are started in the right order and resourced so that no single step starves the rest. The roadmap below is the template GRZAN applies to every import project in Pakistan, adjusted for the client’s certification status and portfolio size.

• The six steps are sequential, and the licence step must precede the dossier filing.
• Payment at the portal is a physical checkpoint that unlocks the upload fields.
• Site inspection can be waived where reference approvals exist.
• Overall timeline positions range from 7–9 months to 9–12 months.

2. Legal basis

The table below sets out the six steps with their content and legal or procedural sources, forming the complete roadmap from classification to certificate. Steps 3 and 4 carry a practical estimate alongside the statutory source, because the exact forms and the sequencing detail rest on administrative practice as much as on the rule text.

Timeline position: practical compilations show that a new registration takes roughly 7–9 months overall; holders of reference-country approvals can take the simplified route, shortening the timeline further; other sources give a position of 9–12 months. Three positions coexist, and this series builds its schedules on 7–12 months (practical estimate, pending written confirmation from DRAP). Clients should budget against the wider end of the band when the certification chain is incomplete, and against the narrower end only when reference approvals are already in hand.

3. Expert insights

Insight 1: Of the six steps, steps 3 and 4 are the easiest to schedule in the wrong order. Companies often prepare the dossier first and handle the establishment licence afterwards. But Rule 14(1)(b) wrote the establishment licence into applicant eligibility, so a reversed order means the dossier is finished with no one available to file it. The mistake is common because dossier drafting feels like the real work while licensing feels like administration, yet the licence is the identity that makes the filing possible at all, and every week spent on a dossier before the licence exists is a week the calendar cannot recover.

Insight 2: The portal payment at step 5 is the physical chokepoint of the process. The practical procedure requires the local representative to make the payment at a designated branch of the National Bank of Pakistan (NBP) and upload the payment receipt to the portal, and the upload fields for the dossier open only once the receipt is linked. This means payment comes first and upload comes after, unlike the “upload first, pay later” sequence of most markets. Teams unfamiliar with the sequence plan the payment as a same-day formality and then discover the bank step, the receipt linkage and the field-opening step each take their own time.

Insight 3: The site verification at step 6 can be waived. Rule 15(2) provides that where the product has been approved by a reference regulatory authority (or holds WHO prequalification, or CE marking issued by a conformity assessment body notified in the NANDO database), the on-site inspection may be waived. This is the most direct dividend of holding reference-country approvals in Pakistan. The waiver removes a scheduling variable that can otherwise add weeks or months, which is why the certification chain should be treated as a timeline tool and not merely as a compliance item. Where the client holds the required evidence, the waiver possibility is asserted at submission rather than left for the reviewer to discover, so the schedule benefit is actually realised.

4. Practical recommendations

• The GRZAN schedule for Pakistan is built in three segments: precondition, parallel, and serial.
• The precondition segment is the establishment licence (it must be done first; the practical duration is about 1–3 months).
• The parallel segment is dossier preparation and the FSC certification chain.
• The serial segment is portal payment, upload, MDB review and certificate issuance.
• We particularly remind clients: do not sit idle while the establishment licence is being processed — the dossier and the certification chain should advance in parallel, otherwise the overall timeline stretches beyond 12 months.
• Payment logistics are confirmed with the local representative in advance: the designated NBP branch, the receipt format and the portal linkage steps, so that step 5 does not stall after the dossier is ready.

5. Verification checklist

• □ Classification completed and the written opinion retained
• □ A local AR holding a valid establishment licence has been appointed
• □ The establishment licence has been obtained or confirmed valid
• □ The dossier has been prepared according to Form-6A / 7A
• □ Portal payment completed and the receipt number obtained
• □ The MDB review status has been confirmed and online deficiency notices can be received

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