Regulatory Open Forum

 View Only

  • 1.  India Importer Label Class B Medical Device

    This message was posted by a user wishing to remain anonymous
    Posted 29-Nov-2022 11:05
    This message was posted by a user wishing to remain anonymous

    Hi Everyone,

    Our company is trying to import a device into India.  It is a class 1 Device in EU and FDA.  We are based in UK and have design control and all product liability, but the device is manufactured under contract in another manufacturing firm in UK.  India (through our distributor) is insisting that the address of the actual manufacturing site be listed.  We are resisting, because the manufacturing site takes no legal responsibility or liability for the device other than meeting our quality and other contractual requirements.  In previous companies I have worked for, the same device was manufactured in multiple locations worldwide and only had the corporate office name and address on the labeling, not the actual manufacturing site.  Has anyone encountered this issue, and how was it addressed?


  • 2.  RE: India Importer Label Class B Medical Device

    Posted 30-Nov-2022 03:37
    Dear anonymous,

    i do not know the Indian medical device regulation by heart but it should be somewhere stated what the definition of the manufacturing site is in India. This might differ from the definition given in the EU and USA. Maybe here we have the solution.
    However, if the definition of the manufacturing site does not differ from the ones in the EU and USA, then you can explain why the "actual" manufacturing site shall not be part of the label as from your perspective as legal manufacturing site (acc. to EU / USA) this site is just a (critical) supplier.

    I hope it helps!

    ------------------------------
    Anja Abelmann
    Göttingen
    Germany
    ------------------------------

    Original Message


  • 3.  RE: India Importer Label Class B Medical Device

    Posted 01-Dec-2022 08:55
    Hi,

    As per Indian Labelling requirements (mentioned in Medical Device Rules 2017), both legal Manufacturer (who is responsible for the design of the device) and Actual Manufacturer (the site from where the final batch release to India takes place) must be listed on the label of the device. The actual manufacturing site details can be added as a sticker or additional label to the device.
    If the final batch release to India is taking place from a third party contract manufacturer, the term "Manufactured by" can be used for the contract manufacturer and "Manufactured For" can be used for legal Manufacturer. 
    For further detailed guidance on labelling requirements, please refer to this blog https://www.linkedin.com/pulse/labelling-requirements-medical-devices-india-8c-healthcare/?trackingId=qk%2F5HIaBI342cqrU3OTiYw%3D%3D 

    Alternatively you can contact me directly at mns.sravan@gmail.com / +91-9390029538.



    ------------------------------
    Sravan Kumar Manchikanti, RAC
    Hyderabad
    India
    ------------------------------

    Original Message


Related Content