8 New Medical Devices Notified Under CDSCO
In a bid to regulate medical and diagnostic devices in India, the health ministry has notified eight medical equipment, in order to ensure better quality of medical devices imported into the country, the Union ministry of health and family welfare has added eight more devices to the list of drugs under the Drugs and Cosmetics Act, 1940, and will now require strict regulatory compliance.
The ministry through a gazette notification issued on Friday i.e on 8th Feb 2019, which specified all implantable medical devices such as cardiac stents, orthopaedic and ocular implants etc, CT scan equipment, MRI equipment, defibrillators, dialysis machines, PT equipment, X-ray machines and bone marrow cell separator as drugs.
Most of these devices are imported and those not regulated didn’t require a license. After having been included in the list these devices will have to follow all norms that are followed by the drug manufacturers and importers,” said a senior health ministry official, requesting anonymity.
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If You Want Medical Devices Services Consultation For Following.
- Medical Device Consulting
- cdsco registration
- FDA 510k Clearance
- ce mark medical device
- CDSCO Manufacturing License
- CDSCO import license
- TURNKEY PROJECT CONSULTANT
- medical device manufacturing
- iso 15378 certification
- 21 cfr part 210 and 211
- ISO 13485 Medical Device Consultant
- Primary Packaging Turnkey Project Consultant
- Clean Room Design Consultant
- manufacturing site conceptualization
- Market Analysis and feasibility for Medical Devices
- manufacturing plant layout design
- medical device design and development
- DMF file submission guideline
- 21 cfr part 820
- qms certification services
- capa management
- design control requirements
- medical device process validation
- combination product
- continuous improvement program
- Medical Device Compliance & Regulatory Services
- Cdsco India authorized agent for medical device
