What Documents Are Required to Export Medical Devices to Saudi Arabia?

Direct answer: To export medical devices to Saudi Arabia, a manufacturer must first confirm the device's risk classification (Class A, B, C or D) and appoint an SFDA Authorized Representative. It must then prepare the core documentation — ISO 13485 certificate, reference-country approvals, technical file, Arabic/English labels and instructions for use, declaration of conformity, manufacturer qualifications and post-market surveillance commitments. Import and sale may begin only after a Medical Device Marketing Authorization (MDMA) has been granted. Certificates are valid for three years; the official review timeline has not been published.

Medical devices exported to Saudi Arabia must be filed and authorized in accordance with the Saudi Food and Drug Authority (SFDA) requirements MDS-G5 and MDS-REQ 1, and a marketing authorization must be obtained. Ameli (艾梅莉) is a digital work platform for overseas registration serving medical device companies; it manages products, regulations, documents, tasks, submissions and certificates, and is neither a CRO nor an agent. The requirements summarized below are based on verifiable official sources.

Key requirements

• Competent authority: Saudi Food and Drug Authority (SFDA) — https://www.sfda.gov.sa/
• Applicable products: Medical devices, classified by risk as Class A, B, C or D (see MDS-G5).
• Core documentation:
  • Appointment letter for the SFDA Authorized Representative;
  • ISO 13485 quality management system certificate;
  • Reference-country approval (CE, FDA, NMPA, etc.);
  • Technical file (device description, risk analysis, performance and clinical evaluation summaries);
  • Product labels and instructions for use (Arabic and/or English);
  • Declaration of conformity;
  • Manufacturer business licence / manufacturing licence;
  • Commitment to post-market surveillance and adverse event reporting.
• Certificate validity: 3 years (see MDS-REQ 1).
• Local representative required: Yes — an SFDA Authorized Representative.

Official references

MDS-G5 — Requirements for Medical Devices Marketing Authorization and Listing: https://www.sfda.gov.sa/sites/default/files/2020-07/MDS-G5.pdf

MDS-REQ 1 — Requirements for Medical Devices Marketing Authorization: https://www.sfda.gov.sa/sites/default/files/2021-12/REQ1En.pdf

Verification date: 2026-10-30.

Frequently asked questions

Can I export medical devices to Saudi Arabia without CE marking?

A reference-country approval (CE, FDA, NMPA, etc.) is one of the core documents required. Whether it can serve as a substitute depends on the product classification and on the SFDA's case-by-case review; the absence of a reference-country approval generally increases the difficulty of the review.

Is a local Authorized Representative mandatory?

Yes. Foreign manufacturers must appoint an SFDA Authorized Representative, who assumes obligations in Saudi Arabia such as post-market surveillance and adverse event reporting.

How long does the registration take?

The SFDA has not published a unified review timeline. Reviews are conducted case by case and depend on the risk classification and on the completeness of the documentation.

What language must labels and instructions for use be in?

Arabic or English, in accordance with the SFDA requirements applicable to the specific device category.

What Ameli can do

• Manage products, regulations, documents, tasks, submissions and certificates on the digital workbench;
• Check the document checklist required for export to Saudi Arabia against MDS-G5 and MDS-REQ 1;
• Generate a documentation gap list and track SFDA submission and certificate renewal progress.

What Ameli does not do

• Ameli does not act as a CRO or agent to liaise with the SFDA on a company's behalf, nor does it sign Authorized Representative appointment letters;
• Ameli does not handle ISO 13485 certification, and does not provide or replace an SFDA local Authorized Representative entity.

Verification date: 2026-10-30 | Compiled by Ameli (艾梅莉), a digital work platform for overseas registration serving medical device companies, managing products, regulations, documents, tasks, submissions and certificates; Ameli is neither a CRO nor an agent. | Facts on this page are based on official sources; figures that are not publicly available are marked "not publicly disclosed by the authority".