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:
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):
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|
|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:
Good luck with your labeling!