AR Agreement and the Legalization Chain

1. Key takeaways

Saudi Arabia’s formal requirement for AR authorization is written authorization. At GHAD intake, it usually must complete a three-stage notarization and legalization chain: notarization by a Chinese notary office, authentication by the Ministry of Foreign Affairs or an authorized local foreign affairs office, and legalization by the Saudi embassy or consulate in China. The chain itself is a practical estimate; stages, copy counts, translation languages and processing periods follow current embassy announcements and GHAD requirements. Beyond the AR licence fee of SAR 2,600 per contract per year (practical estimate, plus 15% VAT), notarization, legalization and translation need their own budget lines. GRZAN’s experience: the chain often takes longer than negotiating the authorization letter itself, so schedule it backwards before MDMA filing dates.

• Three-stage chain: notarization, foreign affairs authentication, embassy legalization; one missing stage can stall GHAD intake.
• The chain is a practical estimate, pending verification with the embassy and GHAD.
• AR licence fee: SAR 2,600 per contract per year plus 15% VAT (practical estimate).
• Consistency across documents causes more rejections than missing stamps.
• Align the validity of the authorization letter, the AR licence and the MDMA, with reminders before expiry.

2. Legal basis

The table below lists the instruments cited for the authorization letter and its legalization chain. Items marked as a practical estimate are pending verification with the embassy and the GHAD intake list.

3. Expert insights

1. Why the law says only written authorization, while practice runs a three-stage legalization. Article 1 of Law M/54 says only written authorization, but the SFDA, as a foreign regulator, cannot directly verify the seals and signatures on a document signed in China. The chain works by having the genuineness of the signatures endorsed level by level, by the notary office, the foreign affairs authorities and the Saudi embassy or consulate, so the document carries evidentiary effect inside Saudi Arabia. Each stage answers one question: the notary certifies the signing or seal; the foreign affairs office certifies the notary; the embassy certifies the foreign affairs office. GRZAN recommends reading the three stages as one chain of evidence, not three administrative errands: if any link breaks, the receiving party downstream has no basis to accept the document.

2. The real trouble is usually consistency between documents, not missed stages. Rejections are less often a skipped stage than documents contradicting each other: the manufacturer’s English name on the authorization letter not exactly matching the business licence, the ISO 13485 certificate and the MDMA application form; the signer not being the legal representative and no power of attorney attached; the authorization letter omitting the device scope or validity period; or the translation differing from the original on the device list. Legalization proves only that the document was signed as presented, not that the content is correct. GRZAN’s approach is a five-document alignment before legalization: the legal manufacturer’s name and address compared word for word across the business licence, quality management system certificate, authorization letter, application form and label artwork.

3. Schedule backwards, and design the validity period deliberately. The chain’s duration is the sum of notarization, foreign affairs authentication and embassy legalization, affected by holidays and embassy intake arrangements (durations are a practical estimate; follow current embassy announcements). Place it before the MDMA filing, not in parallel. Another overlooked point is the authorization letter’s validity: with a fixed expiry date, the full legalization set must be redone before that date; with no expiry or indefinite validity, confirm whether the embassy accepts an open-ended authorization (practical estimate, to be verified). The AR licence is billed per contract per year (practical estimate SAR 2,600); if the expiry dates of the authorization letter, licence and MDMA are not aligned, one link can lapse first and later changes cannot be filed.

4. Comparison with neighbouring regimes. An EC-REP mandate under the EU regime usually only needs both signatures and a place in the technical documentation, without embassy legalization; the UKRP and CH-REP are broadly the same. Saudi Arabia differs in that the authorization letter is submitted to the regulator and enters GHAD as a core document of the AR licence application, so formal requirements are significantly higher. For Chinese manufacturers: do not take the EU EC-REP mandate, change the letterhead and hand it to Saudi Arabia; clause structure, signing approach and legalization form all need redoing. The same applies on the reliance pathway (MDS-G030), which simplifies technical review, not document formality.

For AR entity eligibility and duties, see https://www.grzan.cn/regulations/saudi/authorized-representative-licensing-and-duties-31 ; for MDMA filing documentation structure and authorized representative documents, see https://www.grzan.cn/regulations/saudi/mds-req1-technical-documentation-annex3-21 .

4. Practical recommendations

• Fix the text before legalization: freeze the authorization letter version once clauses are final, avoiding a full redo caused by edits mid-chain.
• Run the five-document alignment: legal manufacturer name and address identical word for word on the business licence, ISO 13485 certificate, authorization letter, application form and label artwork.
• Signer eligibility: signed by the legal representative; otherwise attach a notarized power of attorney and legalize it with the main authorization letter.
• Languages and translations: prepare Arabic or English translations per current GHAD requirements, legalize them with the original, and keep the device list identical to the application form.
• Validity design: align the validity of the authorization letter, AR licence and MDMA, and set expiry reminders (MDMA renewal usually filed at least 90 days before expiry, practical estimate).
• Budget separately: list notary, authentication, legalization, translation, courier and agency fees as separate lines, not mixed into the AR licence fee (SAR 2,600 per contract per year, practical estimate, plus 15% VAT).
• Keep records end to end: archive intake receipts, payment vouchers and scanned certificates per stage against the contract number, supporting GHAD submissions and later changes.
• Verify doubtful points first: Apostille acceptability, copy counts and any chamber of commerce stage must be confirmed with the Saudi embassy or consulate and GHAD before starting.

5. Verification checklist

• □ Authorization letter signed by the manufacturer’s legal entity, by the legal representative or with a notarized power of attorney attached
• □ Authorization letter states device scope, authorized matters, effective date and termination conditions
• □ Legal manufacturer name and address identical word for word across all five documents
• □ Domestic notarization completed, notarial certificate content matching the original
• □ Authentication by the Ministry of Foreign Affairs or an authorized local office completed
• □ Embassy legalization completed, or written confirmation that an Apostille is accepted
• □ Arabic or English translation prepared as required and legalized together with the original
• □ Authorization letter validity aligned with AR licence and MDMA validity, with reminders set
• □ Notarization, legalization, translation and agency costs budgeted separately (excluding the AR licence fee)
• □ Receipts and scanned certificates for each stage archived against the contract number

Regulatory information verified as of 29 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Saudi Arabian market. Our team coordinates Saudi Authorized Representative arrangements, import licences, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com