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Tag: CDSCO

Posted on 22 October 202022 October 2020

INDIA: new categories for the classification of non notified devices

On September 3, 2020, the Indian Central Drugs Standard Control Organization (CDSCO) published the “Notice regarding classification of non notified …

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Posted on 27 March 202027 March 2020

INDIA: CDSCO publishes two amendments of 2017 Medical Device Rule

To reinforce the regulations on medical devices in India, the Central Drugs Standard Control Organization (CDSCO) published two amendments to …

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Posted on 17 October 2018

INDIA: Operational guidance for medical devices and IVDs

Guidance for medical devices (MDs) To support all the stakeholders in the implementation of the Regulation on Medical Devices 2017 …

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Posted on 13 February 201814 February 2018

INDIA: IVDs marketing clampdown

The new Indian Regulation on medical devices and IVDs brought significant restrictions to IVD devices. The number of IVDs requiring …

Continue reading “INDIA: IVDs marketing clampdown”

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+ Why is the CE marking required

  • How will the IVDR 2017/746 affect the Quality System Management?

  • What does the entry into force of IVDR 2017/746 entail for manufacturers of in vitro diagnostic medical devices?

  • What are the main changes compared to the previous Directive 98/79/EC?

  • When will the IVDR 2017/746 enter into force?

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+ How to register radiation emitting medical devices with the CDRH

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+ MDR (EU) 2017/745 impact on CE MDD certificates during the “period of grace”?

  • What is the “period of grace” and how can I take advantage of it?

  • What is the difference between market surveillance, post-market surveillance (PMS) and vigilance?

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+ IVDR (EU) 2017/746

  • What is the in vitro diagnostic medical devices regulation IVDR (EU) 2017/746? When does it apply?

  • When do Manufacturers of in vitro diagnostic medical devices have to conform to the IVDR (EU) 2017/746?

  • How does the Regulation on in Vitro Diagnostic Medical Devices (IVDR) affect the Quality Management System?

  • What are the main changes provided for in the Regulation on in Vitro Diagnostic Medical Devices IVDR (EU) 2017/746?

  • Is it possible to self-certificate devices in the field of the Regulation on in Vitro Diagnostic Medical Devices IVDR (EU) 2017/746?

  • What is the “sell off” provision?

  • Transitional period: can in vitro diagnostic medical devices, conform to the current IVDD, be placed on the EU market after May 26, 2022?

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