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  • 1.  Medical devices in Chile are regulated or not ?

    This message was posted by a user wishing to remain anonymous
    Posted 31-Jul-2018 15:18
    This message was posted by a user wishing to remain anonymous

    Are medical devices regulated in Chile ? .

    According to different sources, Medical devices (other than those listed under a special category) are not regulated. 
    However, I also read that even though they are not regulated a voluntary certification is highly recommended, do you agree ? 

    Many thanks!



  • 2.  RE: Medical devices in Chile are regulated or not ?

    Posted 01-Aug-2018 08:55
    Hello,

    The MD is indeed regulated in Chile.
    We have recently filed a MD Dossier with Chile MOH.

    It is advisable to obtain MD registration requirements from your local agent in Chile.
    To directly contact Chile MOH, may be difficult without an interface.

    Best Regards

    ------------------------------
    PURVI GORADIA
    Manager Regulatory Affairs
    Mumbai
    India
    ------------------------------

    Original Message


  • 3.  RE: Medical devices in Chile are regulated or not ?

    Posted 03-Aug-2018 08:05
    Not ALL medical devices are regulated in Chile.

    Currently there are only 2 kinds of them under mandatory regulation:
     1. Examination gloves, surgical gloves and condoms (Supreme Decree 342/2004
     2. Hypodermic sterile single-use needles and syringes (Supreme Decree 1887/2007)

    So if you are not exporting these 2 devices, then my original email is correct.  However, as of April of this year, the importer has to file a Certificate of Customs Destination (CDA) for all devices not under sanitary registration.

    Based on our distributor, this is done with every shipment so we include the required information on our Invoice as the apply and pay online and the cert is immediately issued.

    ------------------------------
    D Michelle Williams
    VP - Operations
    United States
    ------------------------------

    Original Message


  • 4.  RE: Medical devices in Chile are regulated or not ?

    Posted 01-Aug-2018 09:05
    We sell Class IE, FDA classification, products in Chile which are Class 1 in Chile.  We have the certification which was completed by our Authorized Representative who is also our distributor in Chile.  Since adverse event reporting is mandatory, it allows us easier communication and the ability to keep our products in Chile.  At least, that is what we have experienced.  Here is what I have in my files about medical devices in Chile:

    In general, it is not required to register medical devices, however, it is recommended that they have a voluntary certification.  To do that, appoint an authorized representative in Chile, provide information to ISP (Instituto de Salud Pública or Public Health Institute) which is the name of the AR and verification of conformity to the device requirements in your jurisdiction (our AR did this for us), ISP conducts an audit of the information, and if approved they issue a certificate.

    Since medical devices flow freely in the country except for a very short list, the certificate is viewed as sort of a stamp of "quality approval" in the medical device field and also gives uninterrupted sale if they should ever require registration as we have been told by experts in that area.

    ------------------------------
    D Michelle Williams
    VP - Operations
    United States
    ------------------------------

    Original Message


  • 5.  RE: Medical devices in Chile are regulated or not ?

    Posted 01-Aug-2018 10:05
    Good morning!

    In Chile there is a project of Law under implementation, at this point registration is not yet required. However, the voluntary registration is highly recommended. To do so, your company must have a local legal representation, which means a local partner (i.e. distributor established and properly licenced in Chile).

    There is a Technovigilance Resolution number. 2622/2012 which regulates post market requirements.

    Please feel free to send me an email if you require more details. saadma@marcmconsulting.ca

    Have a pleasant day!

    ------------------------------
    Marcela Saad PharmD, MSc, RAC, FRAPS
    President & Senior Consultant
    MarcM Consulting Canada
    Kitchener, Ontario, Canada
    1 (519) 579-0821

    ------------------------------

    Original Message


  • 6.  RE: Medical devices in Chile are regulated or not ?

    This message was posted by a user wishing to remain anonymous
    Posted 02-Aug-2018 14:58
    This message was posted by a user wishing to remain anonymous

    Thank you very much for your answers.
    Original Message


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