The Union health ministry has amended Rule 109A of the Drugs and Cosmetics Rules (D&C Rules) to make labeling of medical devices mandatory in the country. As per the notification, the label should carry proper name of the medical device; the details necessary for the user to identify the device and its use; the name of the manufacturer and address of the manufacturing premises where the device has been manufactured; the correct statement of the net quantity in terms of weight, measure, volume, number of units, as the case may be, and the number of the devices contained in the package shall be expressed in metric system; and the date of manufacture and date of expiry; alternately the label shall bear the shelf life of the product: Provided that in the case of sterile devices the date of sterilization may be given as date of the manufacture of the device: Provided further that the device is made up of stable materials such as stainless steel or titanium, and supplied non-sterile, date of expiry may not be necessary.

(Pharma Biz)