In revamping the existing unorganized medical device industry, the CDSCO has introduced a new classification scheme that categorizes medical devices into four Classes based on associated risks. It is worth noting that if a medical device is intended to be used in combination with another device, each device is classified independently based on intended use rather than jointly. In addition, any software products that are used in conjunction to operate or influence the use of a medical device, is also classified based on the class of the device it influences.

Medical devices are classified as Class A, Class B, Class C or Class D based on its intended use specified in the draft guidelines below:

I. Non-invasive medical devices that come into contact with injured skin:

    a. Shall be assigned as a Class A device if it is intended to be used as mechanical barrier, for compression or for absorption of exudates only, for wounds which have not breached the dermis and can heal by primary intention

    b. Shall be assigned to Class B, if it is intended to be used with wounds which have breached the dermis, or for the management of the microenvironment of a wound

    c. Shall be assigned to Class C, if it is intended to be used with wounds which have breached the dermis and cannot heal by primary intention 

II. Non-invasive medical devices for channeling or storing substances:

    a. Shall be assigned to Class A if it is intended for channeling or storing body liquids or tissues or liquids or gases for the purpose of eventual infusion, administration or introduction into a human body

    b. Shall be assigned to Class B if it is intended to be connected to an active medical device which is in Class B, C or D or for channeling blood or storing or channeling other body liquids or storing organs, parts of organs or body tissues; provided, that the circumstances when a non-invasive medical device is connected to an active medical device include circumstances where the safety and performance of the active medical device is influenced by the non-invasive medical device, or vice versa.

    c. Shall be assigned to Class C, if it is a blood bag that does not incorporate a medicinal product.

III. Non-invasive medical devices for modifying compositions of substances

    a. Shall be assigned to Class C, if it is intended for modifying the biological or chemical composition of blood or other body liquids or other liquids intended for infusion into the body.

    b. Shall be assigned to Class B, if the intended modification is carried out by filtration, centrifuging or any exchange of gas or of heat.

IV. Other Non-invasive devices 

    a. A non-invasive medical device to which clauses (I), (II) and (III) do not apply shall be assigned to Class A, if it does not come into contact with a person or comes into contact with intact skin only.

V. Invasive (body orifice) medical devices for transient use

    a. Shall be assigned to Class A, if it is intended for transient use; and it is not intended to be connected to an active medical device; or it is intended to be connected to a Class A medical device only. 

    b. Shall be assigned to Class B, if it is intended for use on the external surface of the eyeball; or it is liable to be absorbed by the mucous membrane.

VI. Invasive (body orifice) medical devices for short term use

    a. Shall be assigned to Class B, if it is intended for short term use; and it is not intended to be connected to an active medical device; or it is intended to be connected to a Class A medical device only. 

    b. Shall be assigned to Class A, if it is intended for use in an oral cavity as far as the pharynx or in an ear canal up to the ear drum or in a nasal cavity; and it is not liable to be absorbed by the mucous membrane.

VII. Invasive (body orifice) medical devices for long term use

    a. Shall be assigned to Class C, if it is intended for long term use and, not intended to be connected to an active medical device or it is to be connected to a Class A medical device only. 

    b. Shall be assigned to Class B, if it is intended for use in an oral cavity as far as the pharynx or in an ear canal up to the ear drum or in a nasal cavity; and it is not liable to be absorbed by the mucous membrane. 

VIII. Invasive (body orifice) medical devices for connection to active medical devices

    a. Shall be assigned to Class B, regardless of the duration of its use, if it is intended to be connected to an active medical device which is Class B, C or D. 

IX. Surgically invasive medical devices for transient use

    a. Shall be assigned to Class A, if it is a reusable surgical instrument. 

    b. Shall be assigned to Class C, if it is intended for the supply of energy in the form of ionizing radiation. 

    c. Shall be assigned to Class C, if it is intended to have a biological effect or to be wholly absorbed by the human body. 

  d. Shall be assigned to Class C, if it is intended for the administration of any medicinal product by means of a delivery system and such administration is done in a manner that is potentially hazardous.

    e. Shall be assigned to Class D, if it is intended to be used specifically in direct contact with the central nervous system or for the diagnosis, monitoring or correction of a defect of the heart or of the central circulatory system through direct contact with these parts of the body.

X. Surgically invasive medical devices for short term use

    a. Shall be assigned to Class C, if it is intended to undergo a chemical change in the body. 

    b. Shall be assigned to Class B, if it is intended to be placed into any tooth.

    c. Shall be assigned to Class C, if it is intended for the administration of any medicinal product or the supply of energy in the form of ionising radiation. 

    d. Shall be assigned to Class D, if it is intended to have a biological effect or to be wholly or mainly absorbed by the human body or to be used specifically in direct contact with the central nervous system or for the diagnosis, monitoring or correction of a defect of the heart or of the central circulatory system through direct contact with these parts of the body.

XI. Implantable medical devices and surgically invasive medical devices for long term use

    a. An implantable medical device or a surgically invasive medical device intended for long term use shall be assigned to Class C. 

    b. A long term use medical device

    i. Shall be assigned to Class B if it is intended to be placed into any tooth. 

    ii. Shall be assigned to Class D, if it is intended to be used in direct contact with the heart, the central circulatory system or the central nervous system, to be life supporting or life sustaining; to be an active medical device; to be wholly or mainly absorbed by the human body; for the administration of any medicinal product; or to be a breast implant or if it is intended to undergo chemical change in the body

For a detailed listing of devices based on risk, class and intended use, refer to the notice issued by CDSCO on Nov, 2017 click here.