ELTintern, Author at Medical Device Registration

NPPA MRP Increase Rules for Medical Devices in India: Compliance Guide for Manufacturers & Importers

Medical device manufacturers and importers in India must comply with NPPA MRP increase rules to meet pricing regulations. Certain medical devices in

EU CE Mark vs CDSCO Registration

Understanding the difference between the EU CE Mark vs CDSCO Registration is critical for any medical device producer or importer looking to

LMPC Certificate for Imported Medical Devices: Step-by-Step Process

Before your items may be sold in India, they need to have the LMPC Certificate for Imported Medical Devices. This is one

How to Choose the Right Device Class (A, B, C, D) Before CDSCO Registration?

Choosing the appropriate device class before CDSCO registration is the first and most crucial step for every medical device producer or importer

How can Medical Device Makers in India Get ISO 13485 Certification?

India’s ISO 13485 certification for medical device makers specifies the standards for quality management systems (QMS). This certification is a global standard

Medical Device Registration in Singapore: HSA Approval Process

Medical Device Registration in Singapore: The HSA Approval Process is the method needed by the Health Sciences Authority (HSA) to lawfully sell

Roles of Importers and Manufacturers in Medical Device Rules, 2017

The CDSCO created the Medical Device Regulations, 2017, under the Drugs and Cosmetics Act of 1940 to make sure that medical goods

How to Get ISO 13485 Certification for Medical Device Manufacturers?

The ISO 13485 Certification for Medical Device Manufacturers is an internationally recognised standard that defines the quality management system (QMS) requirements for

CDSCO Import License for Class B Medical Devices in India

Medical devices like blood pressure monitors, suction pumps, and infusion sets are categorized as Class B devices under Indian regulations. To import

Step-by-Step Guide to US FDA 510(k) Clearance for Medical Devices

If you wish to sell a medical device in the U.S., one of the most common routes is the US FDA 510(k)