Medical Devices

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.

Question

What is the medical device definition?

Answer

means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar that Intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of: Diagnosis, prevention, monitoring, treatment or alleviation of disease, o Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, o Investigation, replacement, modification, or support of the anatomy or of a physiological process, o Supporting or sustaining life, o Control of conception, o Disinfection of medical devices, o Providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body and any device which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.

Warning Date	2014-06-26

Saudi Food and Drug Authority warns from using FreeStyle® Blood Glucose strips with FreeStyle® Blood Glucose Meter built into the Omnipod® Insulin management System

2014-06-26

حذرت الهيئة العامة للغذاء والدواء من استخدام أشرطة فحص نسبة السكر في الدم (فري ستايل - (FreeStyle®مع أجهزة قياس نسبة السكر في الدم طراز "فري ستايل" والمدمج في أجهزة أومنيبود (OmniPod)" – المعروف بنظام إدارة الأنسولين" والمصنعة بواسطة شركة "أبوت ديابيتس كير- Abbott Diabetes Care Company".

To report sector-related issues
Call Centre 19999

Other Warnings

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Warning Date	2014-06-24

Saudi Food and Drug Authority warns all consumers against using certain AC/DC power adapters that are used with Breast Pump, manufactured by Playtex Manufacturing Inc

2014-06-24

حذرت الهيئة العامة للغذاء والدواء من إستعمال نوع معين من محولات الجهد الكهربائي (متردد إلى مستمر) والمستخدمة مع مضخة الثدي التي تنتجها شركة بلاي تيكس (Playtex)، وذلك لاحتمال

To report sector-related issues
Call Centre 19999

Other Warnings

All Warnings

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