India: Drug Technical Advisory Board (DTAB) Recommends Amendments To The Medical Devices Rules, 2017

The Medical Devices Rules (MDR), 2017, was published vide G.S.R. 78(E) dated January 31, 2017 under the provisions of Drugs and Cosmetics Rules by the Ministry of Health and Family Welfare (MoH&FW). The MDR, 2017, rules were made effective from January 01, 2018 to regulate the clinical investigation, manufacture, import, and sale & distribution of Medical Devices in the country.

On May 16, 2018, the 79th meeting of Drug Technical Advisory Board (DTAB) considered the representations from the industry/ stakeholders/ associations for amending the MDR, 2017.The DTAB deliberated the matter and recommended to amend the following provisions of DMR, 20181:

The DTAB deliberated the matter and recommended the environmental requirements for the final packing of sterile surgical dressings and also for final packing of condoms. Annexure A of 5th Schedule of DMR, 2017, may be amended as follows:

  1. "Annexure A of the Fifth Schedule of said rules may be amended as follows:

    1. Environmental conditions for weaving and assembly and gauzing should be deleted and only final primary packing for sterile surgical dressings should be included, accordingly, for sterile surgical dressings, Annexure A should be amended and the provision should be substituted with following:

    2. Similarly, for condoms neat & clean environment free from dust etc. shall be replaced instead of 5 μ filter."
  1. The Board (DTAB) deliberated the matter and agreed for the proposal to amend the provisions in Rule 64, making it identical for waiver of clinical performance evaluation of In-vitro Diagnostic medical devices inline with waiver given for medical devices under Rule 63 of the Medical Device Rules, 2017.
  2. The Board recommended that in case a medical device which already exists in the Indian market for use is brought in future under regulation, then such device shall not be a new medical device with condition that the applicant need to provide evidences of safety, performance & effectiveness.
  3. The Board deliberated the matter and agreed for the proposal for enabling NABL accredited laboratories or any hospital accredited by national accreditation board for hospitals and health care providers (NABH) for issuing performance evaluation report under Medical Devices Rules, 2017, to harmonize the requirements at par with the international rules and accordingly, the requirements specified in sub-clause (h) of clause (ii) of Part II of the Fourth Schedule may be amended.
  4. The Board deliberated the matter and agreed for the proposal to include the following medical devices and other high end equipments under the purview of Section 3(b) (iv) of the Drugs and Cosmetics Act, 1940:

    1. All implantable medical devices
    2. CT scan equipment
    3. MRI equipment
    4. Defibrillators
    5. Dialysis Machine
    6. PET equipment
    7. X-Ray Machine
  5. The Board deliberated the matter and agreed for the proposal to incorporate pharmacy degree/ post-graduation as a qualification in Medical Devices Rules, 2017.
  6. The Board deliberated the matter and agreed for the proposal to accept the eIFU (electronic Instructions for Use) as an option in place of traditional paper IFU (Instructions for Use).
  7. The Board recommended the sale of Invitro Diagnostic products shall be undertaken by a valid, whole license holder to Hospitals, Pathology Laboratories, Blood Banks & other such institutions, based on requisition for such products, & the records of which shall be maintained. In case an In-vitro Diagnostic product is to be sold directly to the consumer, it shall be supplied through a valid license holder, for retail sale for such products.
  8. The Board deliberated the matter and agreed for the proposal for notification of bone marrow cell separator as a medical device under Section 3(b) (iv) of the Drugs and Cosmetics Act, 1940.
  9. The Board deliberated the matter and agreed for the proposal for inclusion of medical devices approved by Licensing Authority under Drugs & Cosmetics Rules, 1945, to bear CDSCO logo on its labels.
  10. The Board deliberated the matter and agreed for the proposal for adding to the definition of medical device in clause (ii) of rule 2 and clause (ii) of rule 3(zb) listed currently as, "substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii)" the following words and to read –

    "disinfectants that are used to pre-clean or decontaminate medical devices prior/after to patient use and substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), notified under subclause (ii)".

Further, the Board also recommended for allied amendments in preamble/scope in the rules.

About DTAB

The Drugs Technical Advisory Board is constituted by Central Government under the Drug and Cosmetic Act, 1940, to advise the Central Government and the State Governments on technical matters arising out of the administration of this Act and to carry out the other functions assigned to it by this Act.

Footnotes

1 http://www.cdsco.nic.in/writereaddata/Final%20Minutes%20for%2079th%20DTAB%20meeting%20held%20on%2016_05_2018(1).pdf

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