The Government has increased scrutiny on medical devices, after the Johnson & Johnson faulty hip implants case judgment from Supreme Court, which made many people permanently disabled due to faulty devices. The government plans to bring all medical devices, including implants and contraceptives, under the Central Drugs and Standard Control Organization (CDSCO) so as to improve their safety and quality. In a draft notification released by government on October 18, the Ministry of Health and family Welfare said it is a plans to define all medical devices, Which on  earlier , some as drugs under the Drugs and Cosmetics Act which would be effective December 1.

This latest notification which is going to be amended as “Medical device amendment rule 2019”.These rules shall be amended and come into force on the date of their final publication in the official Gazette. Meanwhile the government has sought comments from all stakeholders within 30 days before the draft notification is finalized. For the timeline for implementation on December 1.

In February, the government had put implantable medical devices, CT scan equipment, MRI equipment, defibrillators, dialysis machines, PET equipment, X-Ray machines and bone marrow cell separators under the purview of the Drugs and Cosmetics Act.

Once these devices are classified as drugs, the Central Drugs Standards Control Organization (CDSCO) will be responsible for regulating them.

A) According to Rule 19 A it is applicable to all devices notified under the Act  except the medical devices and devices specified in the Annexure of Eight Schedule of the rules.

Annexure:

S.No Name Of the device
  1 Disposable Hypodermic Syringes
  2 Disposable Hypodermic Needles
  3 Disposable Perfusion Sets
  4 Substances used for in vitro diagnosis including Blood Grouping Sera
  5 Cardiac Stents
  6 Drug Eluting Stents
  7 Catheters
  8 Intra Ocular Lenses
  9 I.V. Cannulae
  10 Bone Cements
  11 Heart Valves
  12 Scalp Vein Set
  13 Orthopedic Implants
  14 Internal Prosthetic Replacements
  15 Ablation Devices
  16 Ligatures, Sutures and Staplers
  17 Intra Uterine Devices (Cu-T)
  18 Condoms
  19 Tubal Rings
  20 Surgical Dressings
  21 Umbilical tapes
  22 Blood/Blood Component Bags
  23 Organ Preservative Solution*
  24 Nebulizer (effective from 1 Jan. 2020)
  25 Blood Pressure Monitoring Device(effective from 1 Jan. 2020)
  26 Glucometer (effective from 1 Jan.2020)
  27 Digital Thermometer (effective from 1 Jan.2020)
  28 All implantable medical devices Equipment (effective from 1, April, 2020)
  29 CT Scan Equipment (effective from 1, April, 2020)
  30 MRI Equipment (effective from 1, April, 2020)
  31 Defibrillators (effective from 1, April, 2020)
  32 PET Equipment(effective from 1, April, 2020)
  33 X-Ray Machine (effective from 1, April, 2020)
  34 Dialysis Machine (effective from 1, April, 2020)
  35 Bone marrow cell separator (effective from 1, April, 2020)
  26 Disinfectants and insecticide specified in Medical Devices Rules, 2017

B) The manufacturer of a medical device shall upload the information specified on the “Online System for Medical Devices” established by the Central Drugs Standard Control Organization for this purpose

(2) The manufacturer shall upload, –

i. name & address of the company or firm or any other entity manufacturing the medical device along with name and address of manufacturing site of medical device,

ii. Details of medical device

Generic Name Model No. Intended Use Class of Medical device Material of Construction Dimension (if any) Shelf Life Sterile or Non Sterile Brand Name (if registered under the Trade Marks Act, 1999)

iii. Certificate of compliance with respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of such medical device.

iv. Undertaking duly signed by the manufacturer stating that the information furnished by the applicant is true and authentic.

After furnishing of the above information on the “Online System for Medical Devices” established by Central Drugs Standard Control Organization for this purpose by the applicant’s, registration number will be generated. Manufacturer shall mention the registration number on the label of the medical device.

C) The Importer of medical device shall upload the information specified on the “Online System for Medical Devices” established by the Central Drugs Standard Control Organization for this purpose

(2) The importer shall upload, the name of the company or firm or any other entity importing the medical device and specification and standards of that medical device,

ii. Details of medical device

Generic Name Model No. Intended Use Class of Medical device Material of Construction Dimension (if any) Shelf Life Sterile or Non Sterile Brand Name (if registered under the Trade Marks Act, 1999)

iii. Certificate of compliance with respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of such medical device.

iv. Free sale certificate from country of origin.

v. Undertaking duly signed by the importer stating that the information furnished by the applicant is true and authentic.

 After furnishing of the above information on the “Online System for Medical Devices” established by the Central Drugs Standard Control Organization for this purpose by the applicant’s, registration number will be generated. Importer shall mention the registration number on the label of the medical device.

 Central Licensing Authority may verify the documents at any point of time and investigate quality/ safety related failure/ complaints. They can also cancel the registration number or suspend it for such period as the Central Licensing Authority thinks fit either wholly or in respect of any of the medical devices to which it relates, if in its opinion, the registrant has failed to comply with any provision of these rules.


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