Pakistan Letter of Authorization Notarization

1. Key takeaways

Submissions for medical devices in Pakistan must include the manufacturer’s Letter of Authorization, and the practical estimate is that it must be duly notarized in the country of origin. Together with the Free Sale Certificate and the ISO 13485 certificate, it forms the trinity of authorization, market access and quality system, and it is a required document in common for both Class A registration and Class B/C/D registration. The letter is therefore one of the few documents whose fate is tied to every risk class at once: whether a portfolio contains a single Class A item or a full spread across Class B, C and D, each application rests on the same authorization instrument. That universal role is exactly why defects in the letter, defects of scope, of validity or of notarization, are so damaging: they do not delay one submission, they potentially delay every submission the importer intends to file, and repairing them requires action in another country, on another calendar, before the dossier can move again.

• A Letter of Authorization is part of the documents required for imported device applications.
• The practical estimate requires the letter to be duly notarized in the country of origin.
• The importer acts as the authorised representative and stands as the applicant.
• The local representative’s information must appear on the product label.
• Registration and enlistment certificates are issued as Form-8 (local) and Form-8A (imported).
• Because the letter underpins all classes, its scope and validity should be designed once, correctly, for the whole portfolio.

2. Legal basis

The anchors below show how the authorization letter connects the importer’s legal standing to the device’s presence on the market: the rule creates the representative role, the label provision displays it, and the certificate provisions record its outcome.

3. Expert insights

Insight one: the authorization letter is the documentary proof of the legal status of authorised representative. Because Rule 14(1)(b) requires the importer to act in the capacity of an authorised representative, the letter is the instrument that converts that status from a legal description into a written, signed fact. Without it, the applicant’s standing simply does not exist. Everything downstream, the submission, the fee payment, the correspondence with the authority, the eventual certificate, presumes a valid authorization underneath it, which is why seasoned reviewers look for the letter early rather than late.

Insight two: the notarization takes place in the country of origin, not in some third country. The wording of the requirement reads “duly notarized … from manufacturer abroad”, and the notarization step should therefore be completed where the document is issued, in the country where the manufacturer is established. This places the letter on the same path as the embassy attestation chain of the FSC, as two stations on one route (see article 23 of this series). Teams that plan the two documents together, with one consolidated plan covering the notary and, where attestation applies, the onward diplomatic step, save repeated international round trips and keep the two instruments chronologically consistent with each other. The consistency matters in review as well as in logistics: certificates that tell a coherent story about when and where they were produced raise no questions, while certificates whose timelines contradict each other invite them.

Insight three: the validity period and the scope of the authorization must be written clearly. In practice the common problem with authorization letters is not the absence of notarization but an authorized scope that does not cover all products intended for registration, or a validity period shorter than the registration cycle. The letter should cover the product line in one stroke and set its validity as long-term or self-renewing. A narrowly scoped letter forces a fresh notarization every time a new model joins the registration, and a short-dated letter expires while an application is still under review, neither of which is a defect the regulator will fix for the applicant.

4. Practical recommendations

• Issue the letter from a standard template containing six elements: the full names and addresses of the authorising party (the manufacturer) and the authorised party (the importer), the authorized product list including models, the authorized matters (applying for enlistment or registration, submitting documents, paying fees, receiving notifications, post-market vigilance), the validity period of the authorization, termination and assignment clauses, and the signatory and company seal.
• Require the product names and the manufacturer name on the letter to be completely identical to those on the FSC and the ISO 13485 certificate.
• Set the authorized scope wide enough to cover the whole line intended for registration, and the validity long enough to outlast the registration cycle.
• Complete notarization in the country of origin, on the same planning track as the FSC attestation chain.
• Re-issue the letter whenever the product list, the importer or the signing arrangement changes, rather than amending it informally.

5. Verification checklist

• □ The authorization letter contains the six standard clauses
• □ The authorized product list covers all models intended for registration
• □ The validity of the authorization covers the registration and renewal cycle
• □ Duly notarized in the country of origin
• □ Product names identical to the FSC and ISO 13485 certificate
• □ Termination and assignment clauses clearly agreed

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