Dear Anon,
May I know when did you register your medical devices in India. If your devices are class IIa in EU, they would likely be Class B in India and need active import license to sell them in India. .
The new medical device regulations were introduced in in 2017 regulating all the medical devices. The mandatory registration (import license) of all the class A & B medical devices has commenced from 1st October 2022 and from 1st October 2023, Class C & D will need mandatory registration in India. You may refer to the LinkedIn posts explaining the regulations at https://bit.ly/2W3DjBD
If you need any further clarification, please feel free to contact me.
Thank you,
Sravan
+91-9390029538
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Sravan Kumar Manchikanti, RAC
Hyderabad
India
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Original Message:
Sent: 20-Jul-2023 02:16
From: Anonymous Member
Subject: All Indian Medical Devices Soon to be Fully Regulated
This message was posted by a user wishing to remain anonymous
Please could you expand this topic as much as possible. We are a medical device company and have Class IIa products registered in India including dental and zirconia, how will this effect us and what will be the steps needed to ensure we meet these new regulations, regulatory advise is needed please? Will we need an authorized rep in India? What are the stringent conditions taking place with CDSCO? Any advise will be greatly appreciated.
Original Message:
Sent: 19-Jul-2023 17:07
From: Ames Gross
Subject: All Indian Medical Devices Soon to be Fully Regulated
Recently, India Central Drugs Standard Control Organization (CDSCO) announced that all Class C and Class D non-notified medical devices will need a comprehensive license by October 1st, 2023. In 2020, the Indian Ministry of Health and Family Welfare outlined its definition of medical devices, including non-notified medical devices. Today, non-notified Class C and Class D devices do not require an import/manufacturing license to enter India. However, in October, that will change. Please keep in mind that getting a medical device license into India can take up to 9 months including dossier preparation. Thus, applicants must proceed quickly to meet the deadline.
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Ames Gross
President
Pacific Bridge Medical
Bethesda, MD
www.pacificbridgemedical.com
contact@pacificbridgemedical.com
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