概述
Your Independent Authorized Representative in Saudi Arabia
Any medical device manufacturer without a legal entity in Saudi Arabia must appoint an SFDA-licensed Authorized Representative (AR) before its devices — including IVDs, across all risk classes A to D — can be registered or marketed in the Kingdom. The AR is a mandatory legal role: every MDMA registration, SFDA communication, and post-market obligation runs through it.
MRG has acted as an independent Authorized Representative since 2012, holds SFDA Consultation Office license CO-2023-FO-0022 and ISO 13485:2016 certification, and keeps your regulatory file separate from your commercial distributors — so you can add or change distribution partners without putting your Saudi registrations at risk.
重点聚焦领域
- SFDA-licensed AR — CO-2023-FO-0022
- Independent of your distributors
- MDMA registration via GHAD portal
- Full post-market compliance cover
核心能力
核心能力
专为中东及北非市场准入和持续合规而设计的authorized representative法规专业服务。
AR License & Legal Representation
Annually renewable SFDA AR licensing with MRG acting as your legal bridge to the authority for all device classes, including IVDs.
MDMA Registration via GHAD
Preparation, submission, and follow-up of Medical Device Marketing Authorization applications through the SFDA's GHAD portal, including Technical File Assessment under the MDMA2 route.
SFDA Communication
Official communication channel with the SFDA — deficiency letters, clarification requests, and inspection matters answered within regulatory timelines.
Post-Market Surveillance
Adverse event reporting, field safety corrective actions (FSCA), recalls, and registration renewals carried on your behalf in the Kingdom.
AR Transfer Support
Structured transfer of existing registrations from a distributor-AR or outgoing AR to MRG without interrupting your market access.
MDEL & Importer Coordination
Coordination with your local importers and distributors, who separately require a Medical Device Establishment License (MDEL) to bring devices into the market.
我们的流程
法规流程时间线
选择目标市场，查看沙特阿拉伯、阿联酋或埃及的监管机构专属注册路径。
AR Agreement & Appointment
1–2 weeksSign the AR agreement and register the appointment with the SFDA. MRG becomes your legal representative in the Kingdom.
Manufacturer Site Registration
1–2 weeksRegister your manufacturing site with the SFDA through the AR portal — the prerequisite for any device registration activity.
Classification & Technical File Review
2–4 weeksConfirm SFDA risk class (A–D), review the technical file, and identify gaps before submission.
MDMA Submission via GHAD
2–6 monthsSubmit the Medical Device Marketing Authorization application and manage SFDA queries through to approval.
Post-Market Representation
OngoingOngoing vigilance reporting, FSCA management, renewals, and variation submissions as your standing AR.
文件资料
所需文件
选择目标市场，查看沙特阿拉伯、阿联酋或埃及的监管机构所需文件。
Appointment
- Authorized Representative (AR) agreement
- Manufacturer legal entity documents
- ISO 13485 certificate (accredited body)
Registration
- Device description and intended use statement
- Technical file (risk management, clinical evaluation)
- Free Sale Certificate (FSC) / proof of approval in reference markets
Post-Market
- Vigilance and adverse event procedures
- Field safety corrective action (FSCA) records
- Registration renewal and variation documentation
区域覆盖
Authorized Representative
沙特阿拉伯 · 埃及 · 阿联酋 · 中东及北非地区
Saudi Arabia
Why independence matters
Many manufacturers appoint their Saudi distributor as their AR. This is legal — but it hands your regulatory file, and effectively your market access, to a commercial partner. If the relationship ends, untangling the AR designation can stall sales for months. An independent AR keeps the regulatory role separate: you can add, change, or terminate distributors freely while your registrations remain stable and under your control.
Read the full guide: SFDA Authorized Representative requirementsFrom AR appointment to MDMA approval
Appointing MRG as your AR is the first step of Saudi market entry. We then manage device classification, technical file review, and the full MDMA registration pathway through the GHAD portal until marketing authorization is granted.
Read the full guide: Registration of Medical Devices in Saudi Arabia常见问题
常见问题
关于沙特、阿联酋和埃及authorized representative法规要求的常见问题。
A company established in Saudi Arabia that holds an annually renewable AR license issued by the SFDA. It acts as the legal bridge between a foreign manufacturer and the SFDA: every registration, communication, and post-market obligation in the Kingdom runs through the AR.
Full guide: requirements & how to appoint one