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1. What is a medical device ?
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'Medical device' means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article:
A. 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,
- Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
- Investigation, replacement, modification, or support of the anatomy or of a physiological process,
- Supporting or sustaining life,
- Control of conception,
- Disinfection of medical devices,
- Providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body;
B. 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.
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2. What does Authorised Representative (AR) mean?
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Authorised Representative (AR): means any natural or legal person established within the KSA who has received a written mandate from the manufacturer to act on his behalf for specified tasks including the obligation to represent the manufacturer in its dealings with the SFDA.
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3. What does placing on the market mean?
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Placing on the market: means the first making available in return for payment or free of charge of a medical device, with a view to distribution and/or use within the KSA, regardless of whether it is new or fully refurbished.
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4. Who Should Apply for Marketing Authorization?
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Medical device marketing authorization applications shall be made to the SFDA by either :
- a local manufacturer or,
- where the manufacturer is established outside the KSA, by its authorised representative.
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5. How To Enroll ?
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Prior to applying for MDMA application, the applicant must be licensed as Authorized Representative and hold MDEL Authorized Representative for each foreign manufacturer falling under his responsibility, or valid MDNR number in case of Local Manufacturer. The applicant can use the username and password of (MDNR) Account to logon into the MDMA system.
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6. What are the products that required SFDA Medical Devices Marketing Authorization?
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The MDMA required for the following products:
- All Medical Devices and their accessories that will be supplied to the KSA market.
- Contact lenses and laser equipment for cosmetic rather than medical purposes and their accessories.
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7. Can I import medical devices without having Marketing Authorization ?
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- From 14th of February 2011 medical devices that have a SFDA marketing authorization maybe placed on the market within the KSA.
- After 14th of August 2011 only medical devices that have a SFDA marketing authorization may be placed on the market within the KSA.
- After 31st of December 2011 only medical devices that have a SFDA marketing authorization may be put into service within the KSA.
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8. How much should I pay ? How long does the application take?
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Marketing Authorization application fees and review times will be as follow:
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9. What is the period of validity of MDMA?
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The end date of the period of validity will be the same as that of the marketing authorization granted in the GHTF Founding Member jurisdiction unless the GHTF Founding Member’s authorization is open ended and does not indicate a validity end-date, or where the device has been marketed through a self-declaration process (e.g. Class I devices that are not sterile or having a measuring function under EU regulations), where validity shall be 3 years.
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