Notify Body TUV Rheinland, which caters to almost every industry, offering testing, training, inspection, and certification services are now in India. The Central Drugs Standard Control Organisation(CDSCO), has already approved TUV as a Notify Body in India.
An online digital platform- SUGAM has been created to make registration way easier for manufacturers of Medical Devices, as the new rules regulate each one of the factors and activities of Medical Devices, such as clinical trials, labeling, manufacture…
There will be 4 classifications of Medical Devices, A, B, C and D. Low-risk Medical Devices are classified as classes A and B, and classes C and D are high-risk devices, which require the Central Government's attention.
From now, TUV will be able to attend on-site audits of Quality Management Systems of Medical Devices classified as class A and B. and may help class C and D devices with the verification and assessment process.
- Return to main page
- WHAT IS AN UNANNOUNCED AUDIT?
- India’s new regulation for Medic
- LIST OF NOTIFIED BODIES UNDER DIR
- Which countries require CE markin
- DO YOU WANT TO REGISTER YOUR PROD
- Calling Indian manufacturers!
- New regulation to be noted by Med
- The FDA will help Combination Pro
- WHAT TO INCLUDE IN YOUR TECHNICAL
- How to report serious incidents o
- Types of reports for the implemen
- Update in Post-Market Surveillanc
- New medical devices rules approve
- Guidance for clinical evaluation
- Mutual recognition of evaluations
- Japan’s PMDA is offering meetings
- CFDA presents new classification
- NEW FDA APPLICATION FEE FOR MEDIC
- Significant points on how to comp
- New MDR and IVDR requirements won
- EXTENDED TIMELINE for MEDDEV 2.7/
- MEDICAL DEVICES IN MALAYSIA SHOUL
- How to prepare your Design Histor
- NEW FDA registration page is avai
- South Africa’s new regulation - S
- FDA:Dates of compliance with UDI
- New regulations in Vietnam: Regis
- FSC: Reference Countries
- Welcome to CMC