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SAHPRA South Africa: Guideline for Classification of Medical Devices and In Vitro Diagnostics (IVDs)
The South African Health Products Regulatory Authority (SAHPRA)Â has released an updated " Guideline for the Classification of Medical...
Sharan Murugan
Mar 12 min read
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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...
Sharan Murugan
Oct 14, 20242 min read
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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...
Sharan Murugan
May 25, 20242 min read
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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...
Sharan Murugan
May 6, 20242 min read
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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...
Sharan Murugan
Apr 20, 20242 min read
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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...
Sharan Murugan
Jul 17, 20231 min read
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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...
Sharan Murugan
Jun 20, 20231 min read
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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...
Sharan Murugan
Feb 14, 20231 min read
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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...
Sharan Murugan
Jul 27, 20221 min read
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