The medical device industry in India has undergone significant transformation and growth over the past few years. This growth is p...
Client Background This case study focuses on a U.S.-based medical device manufacturer specializing in endotracheal tubes. The c...
Purpose MD-26 is the application form used to seek permission from the Central Licensing Authority (CLA) to import or manufact...
Government Authority (CDSCO) The Central Drugs Standard Control Organisation (CDSCO), a Ministry of Health & Family Welfare...
Government Authority (CDSCO) The Indian Medical Device Regulation, established by the CDSCO, must be followed by all medical de...
An official document issued by the Central Licensing Authorities or State Licensing Authorities that certifies a medical device is...
The Fourth and Fifth Schedule Audits, conducted by either a Notified Body or the Central Licensing Authority (CLA), are essential...
In the context of medical device licensing in India, a post-submission request refers to any communication or additional documenta...
India's burgeoning medical device market presents a lucrative opportunity for manufacturers worldwide. However, introducing innova...
CDSCO - The Government Authority Medical device registration in India is overseen by the Central Drugs Standard Control Organisati...
Introduction to Technical Documentation under EU MDR 2017/745 Technical Documentation under the EU Medical Device Regulation is...
Introduction The EU In Vitro Diagnostic Regulation (IVDR 2017/746) significantly overhauled the regulatory landscape for in vit...
Q: What are the current audit timelines for medical device regulation, and how have they changed recently? A: The audit timelin...
The medical device industry in India has undergone significant transformation and growth over the past few years. This growth is p...
In the Indian medical device regulatory landscape governed by the Central Drugs Standard Control Organization (CDSCO), an "endorse...
Incomplete or Inaccurate Information: Missing Documents: Not including all the required documents as per the CDSCO guidelines...
What is EUDAMED It's a European Data bank on Medical Devices, is a key element under the EU Medical Device Regulation (MDR 2017...
Class A non-sterile non-measuring medical devices - Final notification GSR 777(E) was released by the Indian Ministry of Health an...
Understanding ISO 13485 and Notified Bodies ISO 13485:2016: The internationally recognized standard for quality management sys...
By 2025, the rapidly expanding Indian healthcare sector will generate $280 billion in revenue. One of the top 20 medical device ma...
In India, the form for obtaining permission to import or manufacture a new In-Vitro Diagnostic (IVD) medical device is MD-28. Here...
Definition : The UDI is a series of numeric or alphanumeric characters that provides a globally unique identifier for medical dev...
Technical Documentation under the EU Medical Device Regulation is a thorough collection of documents proving a medical device's co...
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 Vi...