CDSCO Approved Notified Body, India

THE REGULATORY REQUIREMENTS FOR MEDICAL DEVICES IN INDIA

India represents a compelling market opportunity for global medical device manufacturers, with the majority of medical devices sold in India imported from other countries. Substantial growth for the Indian medical device industry is expected to be driven by the upcoming regulatory guidelines i.e. IMDR 2017 issued by CDSCO for medical devices.

NOTIFIED BODY FOR MEDICAL DEVICES IN INDIA

Ministry of Health and Family Welfare Notification No. G.S.R, 78(E) dated 31st January 2017 notifies Medical Devices Rules 2017, has come into force with effect from 1st January 2018.

India’s Central Drug Standard Control Organisation (CDSCO) has Central Licensing Authority (CLA) and State Licensing Authority (SLA) with responsibility for Licensing to Import, Manufacture for sale or for distribution and sale, stock, exhibit or offer for sale. CLA is responsible for all Import Devices Licensing and Class C & Class D Medical Devices Manufacturing, Loan and Wholesale Licenses. SLA is responsible for Class A & Class B Medical Devices Manufacturing, Loan and Wholesale Licenses.

SLA assigns a Notified Body to confirm the requirements of Quality Management System and Technical Review for Class A & Class B Medical Device Manufacturers. CLA may avail the services of a Notified Body for inspecting the manufacturing site of Class C and Class D medical devices and Technical Review. Zenith Quality Assessors Pvt. Ltd. is a registered Notified Body with CDSCO under provisions Medical Device Rules 2017 to carry out audit of manufacturing site under the provision of said rules.

A) Procedure for granting Manufacturing License for Class A & Class B Medical Devices 

Reference Rule 20 of Medical Device Rules 2017 (India)

• Manufacturer to submit application (in form MD-3) through online Sugam portal of Ministry of Health (along with a fee (as per second schedule) and documents (as per part II of fourth schedule) and declaration for compliance with fifth schedule (i.e. Quality Management System).
• The State Licensing Authority will scrutinize the documents. 

For Class B Devices

• Manufacturing site is audited the Notified Body (within 90 days from the date of application)
• Notified body submits audit reports to State Licensing Authority (within 30 days from the audit completion)
• State Licensing Authority scrutinize the audit report, if satisfied grant manufacturing license (in form MD-5)

If not satisfied rejects the application (within 25 days from date of receipt of report)

B) Below link for registration of  CLASS A (NON-STERILE AND NON-MEASURING) Medical Devices

https://cdscomdonline.gov.in/NewMedDev/Homepage

Documents required for Registration of CLASS A (NON-STERILE AND NON-MEASURING) Medical Devices

(i) Name and address of the manufacturing site;

(ii) Details of Class A non-sterile and non-measuring medical devices to be provided:

(iii) an undertaking from the manufacturer stating that the proposed device is a Class A

non-sterile and non-measuring medical device, as per the First Schedule;

(iv) The manufacturer shall self-certify that the product is conforming to the essential

principles checklist of safety and performance of such devices;

(v) The manufacturer shall self-certify to comply with the standards specified in these

rules; and

(vi) an undertaking duly signed by the manufacturer stating that the information furnished

by the applicant is true and authentic.

May also refer to FAQ’s https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/digosfaq19.pdf