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Sharan Murugan
Jul 102 min read
WHO: MeDevIS Platform and EU MDCG Guidance: Classification Rules for IVDs
WHO MeDevIS platform: The World Health Organization (WHO) has established the first global open access clearing house for medical device...
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Sharan Murugan
Jun 282 min read
EC MDCG: Guidance on Clinical Evaluation of Orphan Medical Devices
The European Commission Medical Device Coordination Group (MDCG) has issued a new guidance "Clinical Evaluation of Orphan Medical...
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Sharan Murugan
Jun 232 min read
European Commission: Health Technology Assessment -Guidance on Outcomes for Joint Clinical Assessments and Reporting Requirements
The European Commission has recently published two new guidance documents on Health Technology Assessment (HTA), dated June 13, 2024....
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Sharan Murugan
Aug 24, 20221 min read
Gilead: First Regulatory Approval of HIV Sunlenca® (Lenacapavir) the Only Twice-Yearly HIV Treatment
On 22-August-2022, Sunlenca (lenacapavir) is an injectable HIV medication developed by Gilead Sciences that has been approved to market...
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Sharan Murugan
May 24, 20221 min read
Q&A Guidance on Unique Device Identification system - Medical Device Coordination Group
On 20 May 2022 MDCG, the Medical Device Coordination Group of the European Commission has released a question and answer guide for the...
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