1. F

    Class IIa/b in-country registrations x5 ?

    Hi all. We have two devices that we are wanting to sell within the following 5 countries: South Africa Iran Israel Kuwait UAE One of the devices is Class IIa and the other Class IIb (per the Medical Device Directive). I know some countries within the EU (my main focus) require additional...
  2. J

    GCC Submissions - Average review time for SGH qualification files

    Does anyone know the average review times of the SGH Committee for SGH qualification files? Thanks in advance. :bigwave:
  3. R

    Medical Device Authorised Representation Middle East

    My company is looking to register medical devices in various middle east countries including UAE, Saudi Arabia and Kuwait. Does anyone know of a reputable company that provides authorised representation services in these countries, rather than relying upon the distributor to provide authorised...
  4. B

    Medical Device Registration Requirements in Kuwait

    Does anyone have any info or guidance documents on the requirements for registering medical devices in Kuwait. A distributor we've been in touch with says that all he needs is a letter of authorization from us.
  5. I

    TGA and HC (Health Canada Class 4) in Middle East Countries

    Hi all, we have a client that needs to register his products in the following countries and has a TGA and HC (health canada) certificates only (HC class 4) the countries are: Qatar Oman Baharain Kuwait Jordan Lebanon now, from what I know Jordan require CE or FDA, and Lebanon allows all...
  6. W

    When will Kuwait require Lithium Ion Batteries be tested to IEC 62133 standard

    Can anyone point me to a reference that specifies when Kuwait will require Lithium ion batteries be tested to IEC 62133 standards?
  7. K

    Exporting a Class II Medical Device into Kuwait from the US

    Can anyone point me to a source for identifying the (Quality System) requirements for exporting a medical device into the Kuwait? We have a class II device (US only as of now).