Navigating the regulatory landscape for medical equipment in Germany can be a complex process. The primary regulatory authority responsible for overseeing this domain is the Paul-Ehrlich-Institut, commonly known as the BfArM. The PEI's mandate encompasses the review of medical products for efficacy and compliance with European Regulations. Manufact

Entering the medical instrument market in India presents a unique set of challenges and rewards. A crucial first step for any company looking to sell their products within this dynamic landscape is understanding and complying with the stringent registration system. This process, overseen by the Central Drugs Standard Control Organisation (CDSCO), g

Entering the Indian medical device market presents a significant opportunity for businesses. However, navigating the registration process can be challenging. This guide provides a thorough understanding of the procedure involved in obtaining medical device registration in India. A efficient registration process starts with grasping the legal struct

In India, the Central Drugs Standard Control Organization (CDSCO) regulates medical devices in accordance with the Medical Device Rules 2017 India. For medical device registration India on the Sugam portal, one essential requirement is the submission of a Plant Master File (PMF). This document provides detailed information about the legal manufactu