No, annual renewal is not required for A-class medical device registration with the Saudi Food and Drug Authority (SFDA).

Registration Validity for A-Class Devices:

• A-class medical device registrations are typically valid for 5 years from the date of approval.

Renewal Process:

• Although there is no annual renewal, you must renew the registration every 5 years to maintain the legal ability to market and sell the device in Saudi Arabia.
• The renewal process involves submitting updated documents, which may include:
  • New safety reports or performance data (if applicable).
  • Evidence of compliance with any new regulatory updates or standards.
  • Updated labeling or other required documentation as per SFDA’s latest guidelines.

It's important to begin the renewal process before the registration expires to avoid any interruptions in market access.

Key Points:

• No annual renewal for A-class devices; the registration is valid for 5 years.
• Renewal required every 5 years, with updated documentation and potential fees.
• Timely renewal is crucial to avoid lapses in legal market access.

If you need assistance with the renewal process or have specific questions about requirements, feel free to ask!

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