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Sharan Murugan
Oct 142 min read
MDCG Med. Dev Guidance: Qualification of In Vitro Diagnostic Medical Devices (IVDs)
The Medical Device Coordination Group (MDCG) Â has released a detailed guidance document titled " Qualification of In Vitro Diagnostic...
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Sharan Murugan
May 252 min read
EMA Med Dev. Guidance: New Guidance for Industry and Notified Bodies
The European Medicines Agency (EMA) has recently released updated Q&A guidelines "New Guidance for Industry and Notified Bodies" that...
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Sharan Murugan
May 62 min read
USFDA MD Guidance: Enforcement Policies for Tests During a Section 564 Declared Emergency & for Certain In Vitro Diagnostic Devices
Today (06 May 2024) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released two draft guidances...
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Sharan Murugan
Apr 202 min read
MDCG Guidance: In-Vitro Diagnostic Medical Device Safety Reporting
The European Commission’s Medical Device Coordination Group (MDCG) released updated guidance "Safety reporting in performance studies of...
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Sharan Murugan
Jul 17, 20231 min read
MHRA Med Dev Guidance: In-Vitro Diagnostic Medical Devices on Legislation
Earlier today (17 July, 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "The...
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Sharan Murugan
Jun 20, 20231 min read
USFDA Guidance: Pilot Program Oncology Drug Products & In Vitro Diagnostic Tests
Earlier today (20 June, 2023) the United States Food & Drug Administration's Center for Devices and Radiological Health, Center for Drug...
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Sharan Murugan
Feb 14, 20231 min read
EC-Med Dev.CG - Guidance on Classification Rules for In-vitro Diagnostic Medical Devices
The Medical Device Coordination Group (MDCG) released an updated guidance on "Classification Rules for In-vitro Diagnostic Medical...
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Sharan Murugan
Jul 27, 20221 min read
India CDSCO Guidance: 3 IVD Draft Guidances for Consultation
Recently the Indian Central Drugs Standard Control Organization (CDSCO) released three draft guidance documents, where the In vitro...
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