Test License

Test License for Medical Devices to Import – Checklist And Necessary Documents

Posted by: Saurangi Shah September 21, 2022

Test License for Medical Devices to Import

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21st September, 2022

What's New 2?

Regulation/Guidelines

Clinical Investigation Approvals: An Overview of Forms MD-22 and MD-23

Summary As per MDR 2017, “clinical investigation” means the systematic study of an investigational medical device in or on human participants to assess its safety, performance or effectiveness. Clinical investigations...

15th January, 2025

Regulation/Guidelines

Regulatory Challenges of SaMD: Navigating Global Standards and Compliance

Overview Navigating Software as a Medical Device regulation involves addressing varying global standards, including risk-based classifications. Challenges include managing risks, demonstrating clinical evidence, and ensuring data security. Harmonisation efforts and...

4th November, 2024

Regulation/Guidelines

The Future of SaMD: Emerging Trends and Innovations

Overview The future of (SaMD) Software as a Medical Device will see breakthroughs in Artificial Intelligence-based diagnostics, personalised treatments, and remote monitoring. Emerging trends emphasise real-time data integration, stronger regulatory...

4th November, 2024

Regulation/Guidelines

Understanding SaMD: What Makes Software a Medical Device?

Overview Software as a Medical Device refers to software applications designed for medical purposes, such as diagnosis, treatment, or monitoring, without being part of a physical device. Software as a...

4th November, 2024

Test License

Test License

Test License for Medical Devices to Import – Checklist And Necessary Documents

For Importers To India

Drug

Biologicals

Food Supplements

Medical Device

IVD

Food

Cosmetic

Other

For Manufacturer in India

Drug

Biologicals

Food Supplements

Food

Medical Device

IVD

Cosmetic

Other