This week I will provide some information about labeling in India. CDSCO (Central Drugs Standard Control Organization) regulates the medical device industry in India. Only medical devices that CDSCO has put in the “Notified Devices Category” require registration. There are very few product types on this list and they are regulated as “drugs”. Registration is not required for import of non-notified medical devices in India. Please refer to the link below for a list of the notified device categories that must be registered in India:
[fa icon="clock-o"] 9/18/13 10:22 AM [fa icon="user"] Ryan Kasun [fa icon="folder-open'] india, labeling, medical device industry, medical device, compliance, regulatory, registration
Read More »Make some noise people - the FDA may be making labeling easier on the medical device and biological product industries by way of harmonized symbols!
[fa icon="clock-o"] 4/24/13 8:33 AM [fa icon="user"] Ryan Kasun [fa icon="folder-open'] harmonized symbols, Medical Devices, medical device labels, standards development organization, labeling, regulators, labeling products, FDA, medical device, labels, regulatory structure, biological product, sdo
Read More »There have been a bunch of countries recently that have changed their regulations to require a native language registration label on medical devices. These labels must call out a specific set of information including manufacturing location and address, and the Registration Number of the device. The label doesn’t need much information on it – these labels are usually very small. Countries like China and Brazil have had this requirement for quite some time, and recently countries such as Argentina, Venezuela and Mexico are following suit. I can truly understand why these countries are making this labeling requirement, as it makes it easy to check if a medical device is registered. However, these requirements are causing logistical problems for manufacturers which make the cost of registration in these countries prohibitive.
[fa icon="clock-o"] 1/23/13 8:13 AM [fa icon="user"] Ryan Kasun [fa icon="folder-open'] requirements, argentina, brazil, international, China, labeling, registrations, venezuela, mexico
Read More »Have you ever received a gift that you didn’t really want? Was it an ugly sweater from Great Aunt Margie, or a holiday pillow that didn’t quite match with your décor? People always say, it’s the thought that counts… but if that was the case, gift receipts would not be so important, and return lines at Kohl’s would not be so long the day after Christmas. A bad gift is not the end of the world; we just grin and bear it, and learn to craft a more detailed wish list the next year to avoid any room for ‘interpretation’.
[fa icon="clock-o"] 12/27/12 7:05 AM [fa icon="user"] Ryan Kasun [fa icon="folder-open'] Medical Devices, Holidays, Christmas, labeling, Intended Use, Stents, Risk, Hazards
Read More »During this holiday season, when presents are being packaged and shipped at high volumes, I thought it would be appropriate to talk about the importance of labeling.
[fa icon="clock-o"] 12/17/12 8:13 AM [fa icon="user"] Ryan Kasun [fa icon="folder-open'] MDD, EU, label, Regulatory Affairs, RQS, labeling, ifu, FDA, health canada, medical device, user guide, instructions for use, manual
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