CDSCO Guidance: FAQs for Medical Device Registration in India
Registration of medical devices in India is regulated by the Central Drug Standard Control Organization (CDSCO) under…
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MDR and IVDR Language Requirements Update
The European Commission, in collaboration with Member States, has introduced tables under the Medical Device Regulation (MDR) and…
EU MDR Risk Classification: Guide and Case Study
Manufacturers are responsible for determining…
MHRA’s Revised Medical Device Regulations Roadmap
On the 9th of January, the MHRA in the UK published an updated roadmap to regulation of medical devices in…
Swissmedic Provides Definition for In-House IVDs
Swissmedic has recently updated their FAQ that provides the definition for in-house IVDs, and examples of what is and…
IVDR Clinical Performance Studies: Considerations for EU Approval
In other articles, we have covered considerations for manufacturers about clinical investigations when pursuing CE marking under the…
Australia TGA Approval: Leveraging CE Certification and FDA Clearance
Australia has long been considered a market where device CE certification has presented the easiest pathway to entry for…
Medical Device Vigilance Reporting for Australia TGA Compliance
As in other jurisdictions, the Therapeutic Goods Administration (TGA) has established several requirements related to medical device vigilance reporting…
Medical Device Registration in India
The Central Drug Standard Organization (CDSCO), which falls under the jurisdiction of the Ministry of Health…
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