In Saudi Arabia, the Saudi Food and Drug Authority (SFDA) requires medical device manufacturers to assign an authorized representative (AR) company to act on their behalf in the market at all times. The AR is responsible for the medical device registration, compliance with SFDA regulations, safety, and the implementation of the required regulatory standards.
An expired AR will trouble the shipment clearance at the port so it is best to closely monitor its validity. When needed, changing the authorized representative can be done without the involvement of the previously appointed AR.
In this post, we’ll discuss the definition of AR, its role, and how to assign one for your company.
Which companies can be AR?
Since the authorized representative has to be a local Saudi company, legal manufacturers have two options. The first one is to assign their local distributor as the authorized representative and the second option is to assign a consulting office as a more regulatory-focused company.
In most cases, the local distributor is commercially focused without dedicated regulatory professionals making many medical device manufacturers opt to appoint a consulting company as their authorized representative. The latter option provides more power for the legal manufacturer and freedom in the market.
What is an Authorized Representative?
A Saudi company that holds a signed agreement with a medical device legal 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.
Is AR needed for all medical devices?
It is only required for high-risk medical devices. Therefore, low-risk Class 1 (A) devices do not require the appointment of a local authorized representative in Saudi Arabia.
- Representation at SFDA
- Marketing authorization submission and maintenance for medical devices.
- Listing other Medical Devices
- Implementation of SFDA requested actions.
- Provision of data to SFDA related to quality, efficacy, and safety.
- Postmarketing 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 medical device installation, maintenance, and supply.
AR Licensing Requirments
- Local Saudi Company
- Establishment National Registry Number (MDNR)
- Valid SFDA establishment license for medical devices activity (MDEL)
- Quality management system (QMS)
- 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 required clauses.
- The authorized representative shall have a separate agreement for each manufacturer that it represents within KSA.
- A manufacturer can appoint a different AR for each medical device category or group, therefore different agreements.
- Once the AR Agreement is signed, it must be legalized by both parties in their respective countries.
The validity of the AR agreement is a minimum of one year. Note that the issued AR license’s validity cannot be longer than the validity of the AR Agreement. The applicant can submit an AR application for the validity of one year, two years & so on, and the fees are charged accordingly.
Changing AR in Saudi Arabia
Changing the authorised representative in Saudi can be done without the involvement of the previously appointed AR. It is a process that takes 2 weeks and is followed by the transfer of the associated medical device marketing authorization (MDMA) license.
AR License Fees
The SFDA license fee for an authorized representatives 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 authorized representative basic duties (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.
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