Ministry of Health and Family Welfare issues Medical Devices Rules, 2017, to be effective from 1st January, 2018

Ministry of Health and Family Welfare issues Medical Devices Rules, 2017, to be effective from 1st January, 2018

February 6, 2017 Compliance Blog, Operations 0

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:

  1. The Rules will be applicable in respect of the following:
  2. Substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under Section 3(b)(i) of the Drugs and Cosmetics Act, 1940

[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];

  1.  Substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under Section 3(b)(ii) of the Drugs and Cosmetics Act, 1940

[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].

  1. Classification of medical devices:
  2. Medical devices other than in vitro diagnostic medical devices will be classified on the basis of parameters specified in Part I of the First Schedule appended to the Rules, in the following classes,
  3. Low risk – Class A;
  1. Low moderate risk- Class B;
  2. Moderate high risk- Class C;
  3. High risk- Class D.

 

  1. In vitro diagnostic medical devices will be classified on the basis of parameters specified in Part II of the First Schedule of the Rules, in the following classes,
  2. Low risk – Class A;
  1. Low moderate risk- Class B;
  2. Moderate high risk- Class C;
  3. High risk- Class D.
  1. According to the Rules, persons intending to manufacture a Class A or Class B medical device including in vitro diagnostic medical device are required to obtain licence or loan licence to manufacture for sale or for distribution of such medical devices to the State Licensing Authority.
  2. Persons intending to manufacture Class C or Class D devices will need to obtain licence or loan licence to manufacture for sale or for distribution, as the case may be, of Class C or Class D medical device in Form MD-7 or Form MD-8, respectively.
  3. An application will be required to be to the Central Licensing Authority for manufacturing Small quantity of Class A or Class B or Class C or Class D of medical devices for the purpose of clinical investigations, test, evaluation, examination, demonstration or training.
  4. An authorised agent having licence to manufacture for sale or distribution or wholesale licence for sale or distribution under these rules, intending to import medical devices, will be required to make an application for grant of import licence for medical device to the Central Licensing Authority through an identified online portal of the Ministry.
  5. The licence so obtained will remain valid in perpetuity, unless, it has been cancelled or surrendered, subject to the authorised agent depositing the licence retention fee with the Central Licensing Authority for each overseas manufacturing site and for each licenced medical device after completion of every five years from the date of its issue.
  6. Labelling of medical devices—

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.

  1. Labelling requirements for export of medical devices have also been provided. Some of them are given below:

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.

 

  1. As per the Rules, with effect from 1st January, 2022, a medical device, approved for manufacture for sale or distribution or import, will bear unique device identification which will contain device identifier and production identifier.
  2. Any medical device or new in vitro diagnostic medical device imported or manufactured, for clinical investigation or clinical performance evaluation, test, evaluation, demonstration and training, must be kept in containers bearing labels, indicating the name of the product or code number, batch or lot number, serial number wherever applicable, date of manufacture, use before date, storage conditions, name and address of the manufacturer, and the purpose for which it has been manufactured.
  3. Clinical investigation in respect of investigational medical device in human participants cannot be conducted without the permission granted 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

Source: Ministry of Health and Family Welfare

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