The Ministry of Health and Family Welfare (“Ministry”) has issued the Medical Devices Rules, 2017 (“Rules”). The Rules will come into force from 1st January, 2018.
The highlights of the Rules are given below:
[As per Section 3(b)(i), drug includes all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes];
[As per Section 3(b)(ii), drug includes such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of 11 [vermin] or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette]; and
iii. Devices notified from time to time under Section 3(b)(iv) of the Drugs and Cosmetics Act, 1940
[As per Section 3(b)(iv), drug includes such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board].
As per the Rules, following particulars must be printed in indelible ink on the label, on the shelf pack of the medical device or on the outer cover of the medical device and on every outer covering in which the medical device is packed, namely,-
(a) name of the medical device;
(b) the details necessary for the user to identify the device and its use;
(c) the name of manufacturer and address of manufacturing premises where the device has been manufactured;
(d) the correct statement about 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 expressed in metric system;
(e) the month and year of manufacture and expiry (alternately the label will bear the shelf life of the product):
However, in case of sterile devices, the date of sterilization may be given as date of manufacture of the device, and where the device is made up of stable materials such as stainless steel or titanium, and supplied non-sterile or in case of medical equipment or instruments or apparatus, the date of expiry may not be necessary.
The labels on packages or container of devices for export will be adopted to meet the specific requirements of law of the country to which the device is to be exported, but the following particulars must appear in a conspicuous manner on the label of the inner most pack or shelf pack of the medical device in which the device is packed and every other outer covering in which the container is packed:-
(a) name of the device;
(b) the distinctive batch number or lot number or serial number preceded by the word “Lot No.” or “Lot” or “Batch
No.” or “B. No.” or “Serial No.”;
(c) date of expiry, if any;
(d) the name and address of manufacturer and address of actual premises where the device has been manufactured;
(e) licence number preceded by letters “Licence No. or Lic. No.”;
(f) internationally recognised symbols in lieu of text, wherever required:
However, where a device is required by the consignee not to be labeled with the name and address of manufacturer, the label on the package or container will bear a code number as approved by the Central Licensing Authority and the code number will bear the name of the State or Union territory, in abbreviation, followed by the word “Device” and “manufacturing licence number” and where a device is required by the consignee not to be labeled with the code number also, the label on the packages or container will bear a special code number, as requested by the consignee, and approved by the Central Licensing Authority.
13.Permission is required to import or manufacture a new in vitro diagnostic medical device. An application seeking such permission will have to be made to the Central Licensing Authority along with fees and certain other information as specified in Part IV of the Fourth Schedule