Pakistan Reference Countries: The Seventeen-Authority List Under Rule 15(2)

1. Key takeaways

Rule 15(2) of the Medical Devices Rules, 2017 provides that where a product has been approved by stringent regulatory authorities designated by the MDB, the MDB may issue the enlistment / registration certificate on that basis, and registration shall be based on registration by the following regulatory authorities — the United States, Japan, Australia, Canada, Austria, Belgium, Denmark, France, Germany, Ireland, Italy, the Netherlands, Norway, Spain, Sweden, Switzerland and the United Kingdom (17 in total), or WHO prequalification, or a CE mark issued by a conformity assessment body (CAB) notified in the NANDO database. The list is therefore the backbone of the abridged pathway and of the inspection exemption that travels with it.

• The reference authority list contains exactly 17 jurisdictions, enumerated individually in Rule 15(2) rather than defined by a bloc label.
• Two additional reliance routes stand alongside the list: WHO prequalification, and the CE mark from a NANDO-notified CAB.
• Reliance on the list carries the most direct benefit in the rules — exemption from the premises inspection under Rule 15(1).
• The reference-country list must be read together with the Hague Convention objection states, because attestation strategy differs by country of origin.

2. Legal basis

Every element of the reliance framework — the list, the two additional routes, the exemption, the certificate mechanics and the written-reasons safeguard — sits inside Rule 15 of the Medical Devices Rules, 2017 (notified 2018-01-16). The attestation overlay comes from a separate pair of instruments noted below.

3. Expert insights

Insight one: within the list, the European authorities are named member state by member state. The list reads Austria, Belgium, Denmark, France, Germany, Ireland, Italy, the Netherlands, Norway, Spain, Sweden, Switzerland and the United Kingdom — not a generic reference to the EU. This produces one practical consequence: when CE evidence is relied upon, it must be traceable to a specific member state and a specific CAB. A certificate whose notified body cannot be mapped to a member state fails the very traceability the enumeration was written to secure, so the mapping exercise belongs in dossier preparation, not in deficiency response.

Insight two: the framework also contains two independent routes — WHO prequalification and the CE mark. Even without approval from the US, Japan, Australia or Canada, WHO prequalification or a CE mark issued by a NANDO-notified CAB can serve as the reliance basis. This matters most for product lines aimed primarily at developing markets. A portfolio that never sought FDA or PMDA approval is not therefore locked out of the abridged route; the drafters built an alternative doorway for exactly that situation, and sponsors should evaluate it deliberately rather than assuming the big-four approvals are the only currency DRAP accepts.

Insight three: the most direct dividend of reliance is the inspection exemption. Rule 15(1) states the exemption expressly: for products falling under the countries specified in Rule 15(2), the premises inspection is waived. In Pakistan, the value of reference-country approval is not only acceleration but avoiding a cross-border factory audit altogether. An avoided audit saves the preparation, the hosting burden and the scheduling risk of a DRAP visit, which for many manufacturers outweighs every other advantage of the pathway combined.

Insight four: the reference-country list must be read together with the Hague Convention objection states. Pakistan acceded to the 1961 Hague Convention through the Apostille Ordinance, 2024 (Ordinance No. I of 2024, gazetted 2024-01-26), later followed by the Apostille Act, 2024 (Act No. XXI of 2024, assented 2024-09-06). However, 8 countries (including Germany, Austria, the Netherlands and Denmark) raised objections to Pakistan’s accession; under Article 12 of the Convention, the Convention does not apply between Pakistan and those states. This means a CFS from Germany or similar countries cannot be simplified through an Apostille and must still travel the full consular attestation chain. Document planning therefore splits by country of origin, not by convenience.

4. Practical recommendations

For Class C/D projects, GRZAN builds a reference-country evidence matrix before anything else: it lists every foreign approval the company already holds (FDA 510(k) / PMA, CE MDR / IVDR, WHO PQ and so on), maps each one against the 17-entry list in Rule 15(2), confirms at least one usable evidence item exists, and checks that the certificates remain within their validity periods.

• Compile the complete inventory of the company’s foreign approvals before mapping anything, so the matrix starts from the full picture.
• Map every approval against the 17 reference jurisdictions of Rule 15(2), entry by entry rather than by bloc assumption.
• Confirm at least one usable evidence item exists and is within its validity period before committing to the pathway.
• For CE evidence, confirm it can be traced to a specific member state and a specific CAB.
• Assess whether the premises inspection exemption can be claimed, and record the basis for that claim in the dossier.
• Where no reference-country evidence exists, tell the client plainly that its evaluation route and timelines will differ significantly, and re-plan accordingly.

5. Verification checklist

• □ All of the company’s foreign approval evidence has been listed
• □ Mapped against the 17 reference jurisdictions of Rule 15(2)
• □ Confirmed at least one usable evidence item exists and is within its validity period
• □ Confirmed the CE evidence can be traced to a specific member state and CAB
• □ Assessed whether the premises inspection exemption can apply
• □ Projects without reference-country evidence have had their route and timelines assessed separately

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