FAQs-CDSCO

Medical Devices – Frequently Asked Questions (FAQ)

Medical Device Division of CDSCO (Central Drugs Standard Control Organization) releases FAQ document on periodical basis to clarify the frequently raised questions by industry and other stakeholders .

Latest FAQ Document was released on 3rd April 2025 . This FAQ document is released for Medical Device Sector , not for IVDs.
Doc No.:CDSCO/FAQ/MD/01/2024. Addendum No.: 01. Date: 03.04.2025

CDSCO’s Note :

The replies to the FAQs are aimed only for creating public awareness about Medical Devices Regulation by CDSCO and are not meant to be used for legal or professional purposes. The readers are advised to refer to the statutory provisions of Drugs and Cosmetics Act & Rules and respective Guidelines / Clarifications issued by CDSCO from time to time for all their professional needs.

The document is released as an Addendum to FAQ on Medical Devices Rules, 2017:

Questions covered in the FAQ are listed below :

• Whether the manufacturer or importer need to conduct the Biocompatibility test on the all applied products?
• Whether the manufacturer can release the sterile medical device to the market based on parametric release?
• Whether for a Medical device which is supplied in non-sterile state, the expiry/shelf life is mandatory on its label?
• Whether the validation and QC data of medical device generated by the manufacturer for the medical device which is marketed in the country prior to implementation of the mandatory licensing regime under MDR, 2017 can be considered for grant of manufacturing license in the country?
• In case of Change of constitution of the company/firm holding the manufacturing license under the MDR-2017, whether fresh license is required?
• In case of Change of constitution of the company/firm holding the import license under the MDR-2017, whether fresh license is required?
• In case of Change of constitution of the company/firm holding the registration certificate under the MDR-2017, whether fresh registration is required?
• Whether the applicant can submit a single application for multiple actual manufacturing site for obtaining import license?
• In case of change in the location of manufacturing site of the manufacturer whether a fresh license is required?
• What is a ‘non-sterile medical device’ ?
• What are the packaging and labelling requirements for a ‘non-sterile medical device’ if it is intended to be sterilized before use?
• What is a ‘sterile medical device’ ?
• Whether wholesale licence in Form 20B/21B under Drug Rules, 1945 or Registration certificate in Form MD-42 under Medical Devices Rules,2017 is mandatory for Class A (non-sterile and non-measuring) medical devices?
• What is the regulatory pathway to be followed for obtaining manufacturing/ import license for medical device under MDR-2017?
• Whether the manufacturer of medical device require to obtain ISO 13485:2016 certificate for obtaining manufacturing license under MDR-2017?
• In case of Import of medical devices, whether Brand name of a medical device owned by an Indian authorized agent can be mentioned on the application for import in Form MD-14?
  
  To read the replies shared for each of the FAQs listed above, read the FAQ document released by CDSCO which can be downloaded from the button below

Source of the Document released by CDSCO :
https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/Addendum-0152.pdf