CDSCO has released a document on Frequently Asked Questions on Medical Device Rule, 2017
Central Drugs Standard Control Organization (CDSCO) . Directorate General of Health Services, Ministry of Health and Family Welfare, has released a Document on FAQs on Medical Device Rule 2017, to create public awareness about Medical Devices Regulation.
Source : Doc No.: CDSCO/FAQ/MD/01/2018
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadImmunization/FAQmd2018.pdf
Dear sir
pls confirm the rule also applicable for import of Ventilator parts ????
Yes. Rules are applicable whether the parts are to be sold as independent spare parts for sale or to be used for further manufacturing of the finished good