The Saudi Food and Drug Administration (SFDA) has issued new regulations regrading the sale of medical devices in Saudi Arabia. Under the new regulations the SFDA requires all medical devices manufacturer located outside of Saudi Arabia to have a legal representative in Saudi Arabia “When the manufacturer is located outside the KSA he shall appoint an authorized representative to act on his behalf”. The duties and powers of this representative must be at minimum the following:
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Represent the manufacturer in its dealings with the SFDA.
List each medical device category intended to be supplied to the KSA market.
Complete the marketing authorization application form and provide the SFDA with all necessary supporting documentary evidence, required by Implementing Rule MDS – IR 6 on marketing authorization.
Cooperate with the SFDA on evaluations and actions taken during market surveillance and/or vigilance procedures described in Implementing Rule MDS -IR7 on post-marketing surveillance.
Make the following information available to the SFDA when so required in relation to its market surveillance activities.
The marketing authorization issued by the SFDA for the listed medical devices.
The documentation which was used to demonstrate compliance with the Regulation of the relevant GHTF founding member jurisdictions.
The documents approved by the SFDA demonstrating compliance with the specific Saudi provisions referred to in Article 6 of Implementing Rule MDS – IR6 on Marketing Authorization.
Inform the SFDA of any incidents that have occurred outside the KSA but have consequences for medical devices that have been authorized to be placed on the market of the KSA. The authorized representative shall explain the circumstances and provide information on the corrective action the manufacturer has taken or intends to take.
Inform the SFDA of all field safety corrective actions resulting from post-market follow-up investigations performed by the manufacturer for medical devices that have been authorized to be placed on the market of the KSA. The authorized representative shall explain the reason for the corrective action and provide information on the action the manufacturer has taken or intends to take.
Cooperate with parties involved in distribution activities, installation and maintenance of medical devices that have been placed on the KSA market under its mandate.
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SFDA has also implemented a rule that only Saudi nationals may enter their premises to represent a company.
In an attempt to help foreign medical device manufacturers to abide to these rules and work in the Saudi market, SISC has started a special legal representation package for medical devices manufacturer’s through its partner law office.
The Saudi Food and Drug Administration (SFDA) has issued new regulations regrading the sale of medical devices in Saudi Arabia. Under the new regulations the SFDA requires all medical devices manufacturer located outside of Saudi Arabia to have a legal representative in Saudi Arabia “When the manufacturer is located outside the KSA he shall appoint an authorized representative to act on his behalf”. The duties and powers of this representative must be at minimum the following:
”
”
SFDA has also implemented a rule that only Saudi nationals may enter their premises to represent a company.
In an attempt to help foreign medical device manufacturers to abide to these rules and work in the Saudi market, SISC has started a special legal representation package for medical devices manufacturer’s through its partner law office.
For more information please contact us.