Government Authority (CDSCO) The Indian Medical Device Regulation, established by the CDSCO, must be followed by all medical devices imported into India. In addition to setting drug standards, controlling the quality of imported medical devices, and coordinating the work of state drug control organizations, the CDSCO oversees the approval and regulation of all medical devices…
How Indian manufacturers obtain a CDSCO Free Sale Certificate for export: who issues it by device class, the documents, the fee and where applications fail.
The Fourth and Fifth Schedule Audits, conducted by either a Notified Body or the Central Licensing Authority (CLA), are essential steps in the process of obtaining a manufacturing license for medical devices in India under the Medical Device Rules (MDR) 2017. Let’s delve into each of these audits: Who Are Notified Bodies? Notified Bodies are…
In the context of medical device licensing in India, a post-submission request refers to any communication or additional documentation submitted to CDSCO after the initial application for a license or endorsement has been submitted but before a final decision has been made. Reasons for Post-Submission Requests How to Submit Post-Submission Requests Post-submission requests can be…
India’s burgeoning medical device market presents a lucrative opportunity for manufacturers worldwide. However, introducing innovative medical devices without a predicate (similar device already registered in India) requires a nuanced understanding of the regulatory landscape and a strategic approach. This guide provides an in-depth walkthrough of the process, outlining the key steps, requirements, and potential challenges….
CDSCO – The Government Authority Medical device registration in India is overseen by the Central Drugs Standard Control Organisation (CDSCO), a Ministry of Health & Family Welfare’s Directorate General of Health Services division. The CDSCO is India’s National Regulatory Authority (N.R.A.). • Indian Regulations for Medical Devices · The Drugs and Cosmetics Rules of 1945…
Introduction to Technical Documentation under EU MDR 2017/745 Technical Documentation under the EU Medical Device Regulation is a thorough collection of documents proving a medical device’s conformity to the regulations. It’s essential for both pre-market and post-market compliance. This documentation must be readily accessible to regulatory authorities for inspection. Annex II: Technical Documentation Annex III:…
Introduction The EU In Vitro Diagnostic Regulation (IVDR 2017/746) significantly overhauled the regulatory landscape for in vitro diagnostic (IVD) devices, emphasizing a risk-based approach and enhancing quality and safety. Technical Documentation under IVDR, as detailed in Annex II and III, is central to demonstrating compliance with the regulation. Let’s explore the comprehensive requirements: Annex II:…
Q: What are the current audit timelines for medical device regulation, and how have they changed recently? A: The audit timelines have become more stringent due to increased regulatory oversight. Recent changes include shorter notification periods and more comprehensive audit scopes. Manufacturers need to be audit-ready at all times, emphasizing continuous compliance. Q: What major…
