- Medical Device Registration 2025

When Is Clinical Data Required for Medical Device Approval in India?

Clinical data required for medical device approval in India whenever a new, high-risk, or innovative medical device is introduced into the market.

Oxygen Concentrator Manufacturing License

An Oxygen Concentrator Manufacturing License is a mandatory approval that manufacturers must obtain before producing and selling oxygen concentrators in India. These

E-Commerce for Medical Device Industry

The E-Commerce for Medical Device Industry is growing rapidly as more companies and healthcare providers are moving towards online platforms. Earlier, medical

Why EPR Certification Matters in Medical Devices?

EPR Certification matters in Medical Devices is one of the most important regulatory requirements today. EPR stands for Extended Producer Responsibility, which

Make in India: Assembly or Manufacturing?

Make in India: Assembly or Manufacturing? The initiative was launched to build India as a global manufacturing hub. However, much of the

Hazard Identification and Risk Assessment in Medical Device Design

Hazard Identification and Risk Assessment in Medical Device Design is a critical process that ensures medical devices are safe, effective, and compliant

CDSCO Registration for Hearing Aids

Hearing aids are classified as Class B medical devices in India and must be registered with the Central Drugs Standard Control Organization

CDSCO Registration for Syringe Pumps

Syringe pumps are important medical devices used in hospitals to deliver medicines and fluids in very small and accurate amounts. Since they

Device Master Files DMFs in Medical Device Manufacturing

Device Master Files DMFs in medical device manufacturing are one of the most critical documents that ensure transparency, safety, and compliance in

Risk Classification of Medical Devices

Medical device classification is the first step in the regulatory approval process. It serves as a roadmap, helping manufacturers understand what documentation,