Practical regulatory guides for medical device and IVD manufacturers on CDSCO, US FDA, EU MDR and IVDR, MDSAP and ISO 13485, from the Medfins team.
MDSAP explained: the five participating authorities, why Canada makes it mandatory, why the EU does not accept it, the seven-process audit model, the 2026 changes, and how EN ISO 13485 differs from ISO 13485.
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…
Purpose When is MD-26 Used? Key Sections of the MD-26 Form The exact structure of the form may evolve, so always refer to the latest version on the CDSCO’s Sugam portal. Here’s a general outline of information it includes: Submission Process Important Considerations Understanding MD-27 Permission Steps & Considerations 1. Pre-Application Preparation 2. Clinical Investigation…
Government Authority (CDSCO) The Central Drugs Standard Control Organisation (CDSCO), a Ministry of Health & Family Welfare’s Directorate General of Health Services division, manages medical device registration in India. India’s National Regulatory Authority (NRA) is the CDSCO. Medical devices require close observation since they directly affect public health. To prevent miscommunication or inaccurate information among…
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….
