The Ministry of Health and Family Welfare had on April 12th, 2023 issued a notification under the Central Drugs Standard Control Organisation, notifying Class C and D non-notified medical devices[1] to be included under the licensing regime for grant of manufacturing license under the Drugs and Cosmetics Act, 1940. The objective of this notification was to ensure quality control and a facilitating environment, in light of the rise in the medical devices manufacturing sector due to the COVID-19 pandemic and the Make in India scheme by the government of India
Background
| Medical Devices Risk-Based Classification | |||
| CLASS A | CLASS B | CLASS C | CLASS D |
| LOW RISK
(ex-Alcohol Swabs) |
LOW MODERATE RISK
(ex-Thermometer) |
MODERATE HIGH RISK
(ex-Implants) |
HIGH RISK
(ex-Heart Valve) |
The Ministry of Health & Family Welfare published a notification on February 11, 2020, specifying all medical devices to be regulated under the Drugs and Cosmetics Act, 1940.[2] The process of regulation was optimized in a phase-wise manner, with Class A and Class B medical devices brought under the licensing regime from October 01, 2022[3].
In furtherance of the above phase-wise implementation, the Ministry of Health & Family Welfare published a notification on April 12, 2023 for Class C and D medical devices to be brought under the licensing regime from October 01, 2023.
Current Scenario
As of writing of this update, Class A, Class B, Class C, and Class D are under the licensing regime as stipulated by the Drugs and Cosmetics Act, 1940 from October 01, 2023.
For manufacturing/producing and distributing Class C and D medical devices in India, the following steps are to be taken:
Step 1- Submission of Application in Form MD-7 to the Central Licensing Authority. The form is the initial step towards obtaining the necessary license to manufacture and distribute medical devices.
Step 2- Submission of Documentation viz. Cover Letter, Plant Master File, Device Master File, Quality Management System, Performance Evaluation Report, Constitution Details, Test License and Undertaking.
Step 3- Inspection– Once application will be approved, the Central Drugs Standard Control Organization (CDSCO) shall inspect the manufacturing site. Based on the outcome of the review and inspection i.e. whether the manufacturing facility is in compliance with the Fifth Schedule of the Medical Devices Rules, 2017, the license will be issued in Form MD-9.
[1] Available at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTAwMjM=
[2] Sub-clause (iv) of clause (b) of section 3- “such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board”
[3] Available at: https://dfda.goa.gov.in/attachments/article/460/Gsr102e-Registration-of-certain-medical-devices.pdf
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