CDSCO AI Diagnostics

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E Covering letter to CDSCO Other Medical Device Regulations World-Wide 2
Q Guidance on obtaining NOC from CDSCO India Other Medical Device Regulations World-Wide 2
bio_subbu India’s CDSCO Issues FAQ's on Medical Device Rule, 2017 Other Medical Device Regulations World-Wide 0
P For medical device regulations in India, do I follow CDSCO or BIS ? Other Medical Device Regulations World-Wide 1
bio_subbu India's CDSCO issues a list of Medical Devices that require Registration Other Medical Device Regulations World-Wide 8
bio_subbu India CDSCO issues FAQ on Registration & Import of Medical Devices in India Other Medical Device Regulations World-Wide 0
somashekar Who can provide a WHO GMP certificate in India acceptable to the CDSCO Other Medical Device Regulations World-Wide 6
bio_subbu CDSCO Issues final guidance documents on Registration & Import of Medical Devices Other Medical Device Regulations World-Wide 0
bio_subbu India - CDSCO Issues Draft Rules for Clinical Studies - 2012 Other Medical Device Regulations World-Wide 0
bio_subbu CDSCO-India: Draft Guideline to Calculate Compensation for Victims of Clinical Trials Other Medical Device Regulations World-Wide 0
bio_subbu CDSCO issues Draft Guidelines for Approval of Clinical Trial & New Drugs Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
bio_subbu CDSCO issues Guidance Document for Import & Registration of APIs, and Formulations Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
bio_subbu CDSCO Published Draft version of Medical Devices Guidance Documents Other Medical Device Regulations World-Wide 3
bio_subbu CDSCO?s checklist on importing non-critical IVD products in India Other Medical Device Regulations World-Wide 1
Ajit Basrur CDSCO Guidelines for Port Officers on Imp and Export of Drugs & Cosmetics Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
K MHLW MO169 2021 Japan Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostics Japan Medical Device Regulations 2
L In Venezuela, do I have to register Molecular diagnostics kits or IVD kits? Other Medical Device Regulations World-Wide 1
O Panama - Veterinary Diagnostics Other Medical Device Regulations World-Wide 1
X Egypt In Vitro Diagnostics Medical Devices Registration Other Medical Device Regulations World-Wide 2
M Any new or revised EU or FDA regulatory requirements for IVD diagnostics in 2013? ISO 13485:2016 - Medical Device Quality Management Systems 4
AnaMariaVR2 FDA to keep closer eye on diagnostics: FDA chief US Food and Drug Administration (FDA) 0
H Value of a Seminar - "...Approvals for Diagnostics..." 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Michael Malis FDA will host workshop: "Methodologies for Diagnostics in the Postmarket Setting" US Food and Drug Administration (FDA) 0
C WHO (World Health Organization) Prequalification of Diagnostics Programme ISO 13485:2016 - Medical Device Quality Management Systems 1
A Quality System Templates - In Vitro Diagnostics, Small Company Document Control Systems, Procedures, Forms and Templates 2
marmotte Class II Diagnostics Medical Device: Grounding the chassis or not? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
U FMEA for Service / Diagnostics - Board Level FMEA (at block level not per transistor) FMEA and Control Plans 2
S Is there software that includes diagnostics in an FMEA? FMEA and Control Plans 12

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