In Saudi Arabia, the Saudi Food and Drug Authority (SFDA) requires medical device manufacturers to appoint an authorised representative (AR) to act on their behalf in the market. The AR is responsible for products compliance, safety, post marketing obligations, and renewal of medical device registration.
A valid AR license is mandatory for a product marketing and shipments clearance at the port. When needed, the SFDA enables changing the authorised representative without the involvement of the previously appointed AR.
In this post, we’ll discuss the definition of AR, its role, and how to appoint one for your company.
Table of contents
- What is an Authorized Representative (AR)?
- Who can be AR in Saudi?
- Independent AR vs Distributor as AR
- AR Role
- Is AR needed for all medical devices?
- AR License Requirements
- SFDA Authorized Representative Agreement
- Changing AR in Saudi Arabia
- AR License Fees
- Traits of good AR company
- Need an Authorized Representative in Saudi?
What is an Authorized Representative (AR)?
It is the official representative of the medical device legal manufacturer to the SFDA for the product compliance and safety.
Who can be AR in Saudi?
The authorised representative must be a Saudi company with a signed agreement with the legal medical device manufacturer to act on its behalf in Saudi Arabia.
The authorized representative has to be registered and approved by the SFDA and doesn’t necessarily hold any commercial rights in the market. It facilitates the marketing and sales process by ensuring regulatory compliance.
Authorized representatives in Saudi Arabia must be based in Saudi and have specific licenses and qualifications. Here are the most critical requirements:
- To be a local Saudi company with a trade license for medical devices.
- To be licensed by SFDA as a medical device establishment.
- Maintains a quality management system that is ISO 13485 certified.
- Having dedicated staff for safety and regulatory functions.
Independent AR vs Distributor as AR
Most legal manufacturers choose independent AR instead of appointing the distributor (importer) as their AR. This is because independent AR is the best option for commercial expansion in Saudi; it provides the following benefits:
- More control for the legal manufacturer over their business in the Saudi market.
- Unbiased and commercially neutral relationship.
- Professional regulatory and post-marketing support.
- Enables legal manufacturers to contract with multiple local Saudi distributors.
- Data confidentiality.
- Receives continuous regulatory intel updates.
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- Representation at SFDA
- Submission of marketing authorization applications MDMA and maintenance for medical devices.
- Implementation of SFDA requested actions.
- Provision of data to SFDA related to quality, efficacy, and safety.
- Post-marketing Surveillance
- Submission of Adverse actions that occurred outside the country
- Submission of any required corrective action resulting from the ongoing surveillance.
- Involvement with other parties responsible for installing, maintaining, and supplying medical devices.
Is AR needed for all medical devices?
Yes, it is required for all medical devices. Starting from 27/9/2022, the AR became mandatory for all companies regardless of their medical device risk class.
AR License Requirements
- Local Saudi Company
- Valid SFDA establishment license for medical devices activity (MDEL)
- Quality management system (QMS) and ISO 13485
- Holds an authorized representative agreement with the legal manufacturer.
SFDA Authorized Representative Agreement
The SFDA requires signing a specific agreement template for the medical device authorized representative. The legal manufacturers and local Saudi companies can sign it as-is since it has the minimum necessary clauses.
- The authorized representative shall have a separate agreement for each legal manufacturer.
- A manufacturer can appoint a different AR for each medical device category or group, therefore, separate agreements.
- Once the AR Agreement is signed, it must be legalized by both parties in their respective countries.
The minimum duration of the AR agreement is one year. Note that the validity of the SFDA AR license will be the same as the agreement duration or shorter.
Changing AR in Saudi Arabia
Changing the authorized representative in Saudi can be done without the involvement of the previously appointed AR. The process takes two weeks and is followed by the transfer of the associated medical device marketing authorization (MDMA) licenses. I.e. no need to re-register the products after transferring the AR.
AR License Fees
The SFDA license fee for an authorized representative certificate is SAR 2,600/year (USD 693.33). For more details about SFDA costs, refer to our article: SFDA Fees.
Traits of good AR company
- Complete coverage of the essential duties of authorized representative (Compliance assurance, safety monitoring, etc.)
- Prompt update of the legal manufacturer system with the regulatory milestones such as registration dates, expirations, renewals, etc.
- Prompt sharing of regulatory updates with the ability to identify impact area and level.
- Good legal accessibility to the authorities for support and problem-solving.
- High planning capabilities with the supply chain to ensure securing import permits on time.
- Ability to liaise with global medical device manufacturers and affiliates with good communication skills.
- To resolve in-market issues, such as SFDA inspections and shipment issues at the port.
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