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…
In India, the form for obtaining permission to import or manufacture a new In-Vitro Diagnostic (IVD) medical device is MD-28. Here’s an overview of the process and related forms: Key Forms The Application Process Additional Notes MD-28 Form Structure The exact structure of the MD-28 form can be found on the CDSCO’s SUGAM portal, but…
Purpose and Benefits UDI Issuing Entities in the EU Obtaining and Implementing UDI in the EU Compliance with EU MDR and EU IVDR Key Considerations for Manufacturers MDCG Guidance Documents : Conclusion In the European Union, the UDI system represents a significant advancement in the regulatory landscape for medical devices. It’s aimed at enhancing patient…
