What is the timeframe for reporting adverse event, incident, and complaint?
Answer
Manufacturers, Authorized Representative, Importers, Distributors shall report to the SFDA, upon
becoming aware that adverse event, incident, a complaint has occurred, as follows:
− Not later than (2) working days from the date of awareness, if the adverse event, incident,
and complaint represent a serious public health threat.
− Not later than (10) working days from the date of awareness if the adverse event, incident,
complaint that results in an unanticipated death or unanticipated serious injury.
− Not later than (30) calendar days from the date of awareness for all adverse events, incidents,
complaints which are not associated with high risks.
− If SFDA initiate a report of adverse event, incident, complaint, the response shall be received
within (5) working days.
Question
When should medical device adverse event, incident, and complaint be reported?
Answer
The local manufactures, the overseas manufactures, Authorized Representative, Importers, Distributors and the health practitioner must report incidents and adverse events to SFDA upon becoming aware it happens
Question
Can I appeal to the rejection decision ?
Answer
The appeal process to rejected shipments is published at: (Click here)
Question
What are the medical devices clearance conditions and requirements ?
Answer
Medical Device clearance conditions and requirements are published at: (Click here)
Question
What items (products) need to be provided with a temperature indicator/ data logger during transportation?
Answer
Medical IVD's devices,
Medical IVD and non-Medical IVD’s.
Chilled and frozen foods.
Any shipment requires a specific temperature for transportation and/or storage, according to the manufacturer's instructions, shall contain data logger (digital temperature indicator) activated from the time of shipping.
Question
What are the custom entry ports designated to medical device products?
Answer
1. King Khaled airport - Riyadh
2. Dry port - Riyadh
3. King Abdulaziz airport - Jeddah
4. Jeddah Islamic sea port - Jeddah
5. King Abdullah Sea port - Rabigh
6. King Fahad Airport - Dammam
7. King Abdulaziz sea port - Dammam
8. King Fahd Causeway – Al-Khobar
9. Al-Batha outlet - Al-Ahsaa
10. Al-Hadethah outlet – Qurayyat
Question
If there are many deferent types of accessories related to the medical device, is it allowed to register them in one application?
Answer
Yes, it is allowed if they are made for the main medical device
Question
What is medical device Labelling?
Answer
Means written, printed or graphic matter
a) Affixed to a medical device or any of its containers or wrappers.
b) Information accompanying a medical device, related to identification, technical description.
c) Information accompanying a medical device, related to its use, but excluding shipping documents.
Question
What is accessory definition?
Answer
Means a product intended specifically by its manufacturer to be used together with a medical device to enable that medical device to achieve its intended purpose.
Question
What is the National Center for Medical Devices Reporting (NCMDR)
Answer
An organization managing a database of information on safety and/or
performance related aspects of medical devices and employing staff
capable of taking appropriate action on any confirmed problems.
