Assisted Reproductive Technology Procedures

Mr. Karthi Thiyagarajan

Sale of In-Vitro Fertilization Media, Reagents and related Consumables used in Assisted Reproductive Technology Procedures The Apex Drug and Medical Device Regulator has strictly restricted the supply of critical Laboratory Consumables used in In-Vitro Fertilization (IVF) and Assisted Reproductive Technology… 

Industry Update – Guidance Document published by FDA for Small Entities

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Small Entity Compliance Guide – Guidance Document published by FDA FDA published a final rule in the Federal Register entitled “Medical Devices; Laboratory Developed Tests” (“LDT Final Rule”), amending FDA regulations to make explicit that in vitro diagnostic products (IVDs)… 

Frequently Asked Questions (FAQs) on Medical Device Rule, 2017

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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… 

MDR 17 – Risk Classification of Non notified MD & IVD

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Announcement from CDSC0 Notice regarding classification of non notified medical devices – https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NjQ1MA== Notice regarding classification of non notified IVD – https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NjQ0OQ==