R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.

 

India Medical Device Labeling

 

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:

http://cdsco.nic.in/Medical_div/list%20of%20notified%20medical%20device.0001.pdf

If your device does not fall into one of the types on this list, it doesn’t require product registration.

For Medical Devices that do fall under Notified Devices Category (per CDSCO), products are required to have labeling as per the labeling requirements under GHTF guidelines and Rule 96 of the Drugs and Cosmetic Act, (which can be found at the following link):

http://cdsco.nic.in/Drugs&CosmeticAct.pdf

In India, medical devices are categorized as “drugs”. Some of the labeling requirements in Rule 96 are specific to drugs, and will not pertain to medical devices. According to rule 96, the following items must be on the labeling for Notified Devices:

1. product description

2. number of units of contents,

3. The name of the manufacturer and the address of the premises of the manufacturer where the product has been manufactured.

4. A distinctive batch number, being preceded by the words ‘Batch No.’ or ‘B. No.’ or ‘Batch’ or ‘Lot No.’ or ‘Lot’.

5. Every product manufactured in India shall bear on its label the number of the license under which it is manufactured, the figure representing the manufacturing license number being preceded by the words “Manufcaturing Licence Number” or “Mfg. Lic. No.” or “M.L.”.

6. Date of manufacture, and the date of expiration

In addition, these products also need to comply with labeling and local laws as per Drug Price Control order and Standard Weights and Measures Act 1976 & Rules 1977.

As per Standard Weights and Measures Act 1976 & Rules 1977, the manufacturer shall indicate the following information on the package:

1. Name and Address of Manufacturer/Importer/Packer
2. Quantity
3. Generic Name of Product
4. Maximum Retail Price (M.R.P.) inclusive of all taxes:
5. Date of manufacture/ (Imported or Packed) Expiration Date
6. Contact information (Name, Address, Telephone Number and E-mail address) for Customer Complaint

Most of which is redundant.

Some frequently asked questions can be found on the CDSCO website at:

http://cdsco.nic.in/FAQ-IMPORT%20&%20REGISTRATION%2002022013_DONEE.pdf

Good luck with your labeling!

Crash Those Symbols - FDA Proposed Rule

Make some noise people - the FDA may be making labeling easier on the medical device and biological product industries by way of harmonized symbols!

Small Label, Big Impact

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.

Unwanted Gifts

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’.

Labels impact the device

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.

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