In an attempt to give our viewers a more detailed explanation of the CDSCO classification systems of the New Medical Device Rules in India, Morulaa HealthTech is publishing their second article on the proposed medical device rules, 2016. The first article covered 15 key points of the new regulatory medical device rules of CDSCO titled as – Regulatory Updates India: New Medical Device Draft Rules, 2016.

Central Drugs Standard Control Organization (CDSCO) is the Indian regulatory authority for medical devices, Drugs, IVDs and Cosmetics in India under the Ministry of Health and Family Welfare. This medical device rules is a long term request of the medical device industry in India. The CDSCO released the first draft of the medical device rules earlier this year and on 17 Oct, 2016 “The Medical Device Rules, 2016″ released in the Gazette notification and had a 30 day public comment period for the industry and interested people on this new medical device rules of 2016 in India.

“The Medical Device Rules, 2016”:

The text of the medical device rules defines different types of medical devices and categorizes them by threat and establishes a process of regulation for all except the medical products that cause the least risk to users.

Previously (Pre- Medical Device Rules, 2016) Medical Devices were not assigned any classification system by Indian FDA (CDSCO). Under the new Medical Device Rules, 2016, the proposal is to break medical devices and in-vitro diagnostics (IVD’s) into 4 groups, ranging from Class A to Class D, classified on the basis of parameters specified in the Official Gazette: Low risk – Class A, Low moderate risk – Class B, Moderate high risk – Class C, High risk – Class D.

The new system of medical device rules is planning to categorize various non-invasive devices, reusable surgical instruments and other products as Class A.

The earlier medical device rules covered medical devices to, but was considered inadequate at addressing the needs of the medical device industry sector. Officials felt a change in new regulation was needed to facilitate the ease of doing business and to enhance the quality and efficacy of medical device and IVDs sold in India.

The previous rules covered select medical devices like spinal needles, cochlear implants, annuloplasty rings, trachestomy tubes, syringes and needle, breast implants, dental implants, surgical sealants, heart valves, cardiac stents, orthopedic implants, endotracheal tubes, and catheters, tissue grafts, bone cements etc., Now the classification system introduced is more in line with the International systems and covers all medical devices.

Notes:
  1. If the device is planned to be used in combination with another medical device the classification rules shall apply separately to each of the devices as per the regulation.
  2. Software which operates a device or influences the use of a device falls automatically in the same class.

Class A Medical Devices:

The classification system of medical device rules, 2016 has the below medical devices under Class A.

Non-invasive medical devices which come into contact with injured skin shall be assigned to Class A 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

Non-invasive medical devices for channeling or storing substances shall be assigned to Class A Subject to sub-clauses (b) and (c) 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.

Other non-invasive medical devices to which clauses (i), (ii), (iii) do not apply and come into contact with person or comes into contact intact skin only shall be assigned to Class A as per the new medical device rules.

Invasive (body orifice) medical devices for transient use subject to sub-clause (b), shall be assigned to Class A ) it is intended for,

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

Invasive (body orifice) medical devices for short term use referred to in sub-clause (a) shall be assigned to Class A it is intended for,

  • use in an oral cavity as far as the pharynx or in an ear canal or in a nasal cavity and it is not liable to be absorbed by the mucous membrane.

Active diagnostic medical devices referred to in sub-clause (a)(1) shall be assigned to Class A if it is intended to be used solely to illuminate a patient’s body with infrared spectrum.

Other active medical device to which provisions (xii) and (xiii) do not apply shall be assigned to Class A.

Medical devices incorporating animal or human cells, tissues or derivatives referred to in sub-clause shall be assigned to Class A.

Class B Medical Devices:

The medical device rules, 2016 has the below medical devices classified under Class B.

Non-invasive medical devices which come into contact with injured skin subject to sub-clause (c) or medical devices for channeling or storing substances referred to in sub-paragraph (a) shall be assigned to Class B.

Non-invasive medical devices for modifying compositions of substances as referred to in sub-clause (a) shall be assigned to Class B.

Invasive (body orifice) medical devices for transient use referred to in sub-clause (a) shall be assigned to Class B if it is planned,

  • for use on the external surface of any eyeball or it is liable to be absorbed by the mucous membrane.

Invasive (body orifice) medical devices for short term use Subject to sub-clause (2)shall be assigned to Class B if it is intended,

  • for use on the external surface of any eyeball; or
  • It is liable to be absorbed by the mucous membrane.

Invasive (body orifice) medical devices for long term use referred to in sub-clause (a) shall be assigned to Class B under the new medical device rules

Invasive (body orifice) medical devices for connection to active medical devices 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 in Class B, C or D.

Surgically invasive medical devices for transient use subject to sub-clauses (b) to (g) intended for transient use shall be assigned to Class B.

Surgically invasive medical devices for short term use Subject to sub-clauses (b), (d) and (e) intended for short term use shall be assigned to Class B.

Implantable medical devices and surgically invasive medical devices for long term use shall be assigned to Class B by the medical device rules, 2016.

Active therapeutic medical devices for administering or exchanging energy Subject to sub-clause (b) shall be assigned to Class B, if it is intended.

Active diagnostic medical devices subject to sub-clauses (b), sub-clause (g) and (c), an active diagnostic medical device shall be assigned to Class B intended for,

  • supply energy which will be absorbed by the human body,
  • capture any image of the in vitro distribution of radio pharmaceuticals,
  • the direct diagnosis or monitoring of vital physiological processes,
  • for the administration or exchange of energy to or with a human body

Medical devices incorporating medicinal products referred to in sub-clause (a) shall be assigned to Class B if it is intended to be placed into any tooth.

The Medical device rules also states that Medical devices used for sterilization or disinfection shall be assigned to Class B.

Class C Medical Devices:

The classification system of medical device rules, 2016 has the below medical devices under Class C.

Non-invasive medical devices which come into contact with injured skin shall be assigned to Class C if it is intended,

  • to be used principally with wounds which have breached the dermis and cannot heal by primary intention.

Non-invasive medical devices for channeling or storing substances referred to in sub-clause (a) shall be assigned to Class C if it is a blood bag that does not incorporate a medicinal product.

Non-invasive medical devices for modifying compositions of substances subject to sub-clause (b) 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.

Invasive (body orifice) medical devices for long term use subject to sub-clause (b), an invasive (body orifice) medical device 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.

Surgically invasive medical devices for transient use shall be assigned to the same class as the active medical device to which it is intended to be connected.

surgically invasive medical device shall be assigned to Class C if it is intended for,

  • the supply of energy in the form of ionising radiation,
  • having a biological effect or to be wholly or mainly absorbed by the human body,
  • any medicinal product by means of a delivery system.

Surgically invasive medical devices for short term use Subject to sub-clause (c) shall be assigned to Class C if it is intended ,

  • to undergo a chemical change in the body,
  • for the administration of any medicinal product or the supply of energy in the form of ionising radiation.

Implantable medical devices and surgically invasive medical devices for long term use subject to sub-clauses (b), (c) and (d ) shall be assigned to Class C.

An active therapeutic medical device shall be assigned to Class C, if it is intended for the control or monitoring, or to be used to directly influence the performance of a Class C active therapeutic device.

Active diagnostic medical devices referred to in sub-clause (a) shall be assigned to Class C, if it is intended by its product owner specifically for monitoring.

An active diagnostic medical device under medical device rules, 2016 shall be assigned to Class C, if it is intended for the emission of ionizing radiation.

An active diagnostic medical device shall be assigned to Class C, if it is intended for the control or monitoring, referred to in sub-clause (d) and administration or removal of the medicinal product body liquid or other substance referred to sub-clause (f).

Medical devices for sterilization or disinfection subject to sub-clause (b), a medical device shall be assigned to Class C, if it is intended to be used specifically for,

  • the sterilization of any other medical device,
  • the end-point disinfection of any other medical device; or
  • the disinfection, cleaning, rinsing or hydration of contact lenses.

Medical devices for contraceptive use subject to sub-clause (b), if a medical device intended to be used for contraception or the prevention of the transmission of any sexually transmitted disease shall be assigned to Class C.

Class D Medical Devices:

The medical device rules, 2016 has the below medical devices classified under Class D.

Surgically invasive medical devices for transient use shall be assigned to Class D under the classification system if it is intended to be used specifically in direct contact with the central nervous system or diagnosis, monitoring or correction of a defect of the heart or central circulatory system.

Surgically invasive medical devices for short term use 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.

Implantable medical devices and surgically invasive medical devices for long term use shall be assigned by this new medical device rules to Class D classification, 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,
  • if it is intended to undergo chemical change in the body.

Medical devices incorporating medicinal products subject to sub-clause (b) shall be assigned to Class D, if it incorporates as an integral part a substance,

  • if used separately, may be considered to be a medicinal product; and
  • is liable to act on a human body with an action ancillary to that of the medical device.

Medical devices incorporating animal or human cells, tissues or derivatives subject to sub-clause (b) shall be assigned to Class D, if it is manufactured from or incorporates,

  • cells, tissues or derivatives of cells or tissues, or any combination thereof, of animal or human origin, which are or have been rendered non-viable; or
  • cells, tissues or derivatives of cells or tissues, or any combination thereof, of microbial or recombinant origin.

Medical devices for contraceptive use referred to in sub-clause (a) shall be assigned to Class D, if it is an implantable medical device or an invasive medical device intended for long term use.

This classification system of the Medical Device Rules, 2016 by the CDSCO is a forward step towards registration of medical devices and IVDs to enhance a transparent and efficient regulated Indian market. Follow and Subscribe to our website’s blog section to learn more this new medical device rules of CDSCO regulatory system in India.