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…
The medical device industry in India has undergone significant transformation and growth over the past few years. This growth is partly driven by the regulatory changes introduced by the Central Drugs Standard Control Organization (CDSCO), the national regulatory body for pharmaceuticals and medical devices in India. Among the various regulatory roles and entities, the Indian…
In the Indian medical device regulatory landscape governed by the Central Drugs Standard Control Organization (CDSCO), an “endorsement” refers to the official approval or authorization granted for modifications or additions to an existing medical device manufacturing license. This endorsement process is facilitated through various MD forms, each catering to specific scenarios. Types of Endorsements: General…
Incomplete or Inaccurate Information: Non-Compliance with Regulations: Quality Management System Issues: Other Potential Mistakes: Insufficient Manufacturing Facility Design: Not meeting CDSCO guidelines for cleanroom classifications, layout, utilities, etc. Equipment Gaps: Lack of necessary equipment for manufacturing, testing, and quality control, or failing to provide calibration and maintenance records for the equipment. Personnel…
What is EUDAMED It’s a European Data bank on Medical Devices, is a key element under the EU Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746). It’s a comprehensive database designed to strengthen market surveillance and transparency in the medical device sector in Europe. Registration in EUDAMED is a critical…
Class A non-sterile non-measuring medical devices – Final notification GSR 777(E) was released by the Indian Ministry of Health and Family Welfare on October 14, 2022, formally exempting Class A non-measuring and non-sterile medical devices from the Import License (MD-15) procedure. Following this most recent final notification from the MoHFW, Class A medical devices that…
Understanding ISO 13485 and Notified Bodies Key Steps for ISO 13485:2016 Implementation and Certification: 1. Preparation and Planning 2. QMS Development 3. QMS Implementation 4. Selection of Notified Body 5. Certification Audit Process 6. Surveillance Audits Tips for Success Choosing the body itself: this article covers the ISO 13485 relationship with a notified body. Which…
By 2025, the rapidly expanding Indian healthcare sector will generate $280 billion in revenue. One of the top 20 medical device markets worldwide is the Indian market. By 2025, its current valuation of $5.2 billion is anticipated to rise to $50 billion. In India, the Drugs and Cosmetics Act of 1940 governed devices; there were…
