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Roadmap to Regulate All Medical Devices

  • Posted By
    10Pointer
  • Categories
    Polity & Governance
  • Published
    15th Feb, 2020
  • Context

    • The Ministry of Health and Family Welfare notified changes in the Medical Devices Rules, 2017 to regulate medical devices on the same lines as drugs under the Drugs and Cosmetics Act, 1940.
  • What are the changes in the rules that were notified?

    • Called the Medical Devices (Amendment) Rules, 2020, these are applicable to devices “intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals” (as notified by the ministry) and require online registration of these devices “with the Central Licensing Authority through an identified online portal established by the Central Drugs Standard Control Organisation for this purpose”.
    • Among the information that the manufacturer has to upload are “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 (and) 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”.
    • This would mean that every medical device, either manufactured in India or imported, will have to have quality assurance before they can be sold anywhere in the country.
    • After furnishing of the above information on the ‘Online System for Medical Devices’ established by Central Drugs Standard Control Organisation 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, reads the gazette notification.
  • What are the items covered under the Medical Device Rules?

    • A large number of commonly used items including hypodermic syringes and needles, cardiac stents, perfusion sets, catheters, orthopaedic implants, bone cements, lenses, sutures, internal prosthetic replacements etc are covered under the new rules and will have to comply starting April.
    • For some items such as sphygmomanometers (used to monitor blood pressure), glucometers (to check blood sugar), thermometers, CT scan and MRI equipment, dialysis and X-ray machines, implants etc, different deadlines for compliance have been set.
    • For example for the first three, it is January 2021, for the others it is April next year. For ultrasound equipment, it is November 2020.
  • When will it come into effect?

    • These Medical Device Rules, 2020 will come into full effect on April 1, 2020.
    • The notification calls for a voluntary registration within a period of 18 months from April 2020 and obtaining manufacturing/import license under Medical Device rules within a span of 36 months for class A&B devices and 42 months for class C&D devices.
    • After the 18 months period for temporary registration all non-Notified medical devices must be registered (i.e., by October 1, 2021) in the CDSCO’s on-line portal and shall bear the temporary registration number on the label of the product.

Quick Recap
  1. Changes in the Medical Devices Rules, 2017—notified by Ministry of Health and Family Welfare—under Drugs and Cosmetics Act, 1940—called the Medical Devices (Amendment) Rules, 2020.
  2. An Online System for Medical Devices’ for furnishing the informatiohn has been provided by Central Drugs Standard Control Organisation (CDSCO).
  3. Medical Device Rules, 2020 will come into full effect on April 1, 2020.
  4. All non-Notified medical devices must be registered (i.e., by October 1, 2021) after 18 months period for temporary registration
  5. CDSCO, under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India.
  6. CDSCO the national regulatory body for Indian pharmaceuticals and medical devices, and serves parallel function to the European Medicines Agency of the European Union, the PMDA of Japan, the Food and Drug Administration of the United States and the Medicines and Healthcare products Regulatory Agency of the United Kingdom.

Verifying, please be patient.