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FDA 510k

Post Approval Changes

For major changes the license holder must obtain prior approval and for any minor change as specified in Sixth Schedule of India MDR, a notification to State or Central licensing authority required.

Medical Device QMS

The manufacturing site must comply with the requirements of quality management system as specified under Fifth Schedule of India MDR, which is required to produce medical devices of same quality.

Indian Agent

An authorized agent should act as the official representative for obtaining import licence in India and submit all necessary documents, as defined in the Fourth Schedule, for the import licence of medical device.

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India Medical Device Regulation

The Government of India proposed some rules in 2017 for medical device sector in order to strengthen the healthcare system in India, and to ensure the quality, safety and performance of the medical devices that are manufactured or imported. These rules are called the Medical Device Rules, 2017 and come into force from 1st January 2018.

 

Compared to earlier guidelines and regulations on medical devices in India, these rules provides clear information about the risk based classification of devices, timelines about each process, which is helpful to the industry to make a proper planning for their market launch.

 

The Medical Device division in the CDSCO having the responsibility for implementing the rules. And, to meet the current healthcare and industry requirements these Medical Device Rules are amending, after taking opinions from different sections, as required.

Classification of Non Notified Devices

Guidance issued by Government of India on 3rd Sep 2020 regarding Device Classification of Non Notified Devices.

Regulatory Strategy

A Regulatory strategy is inevitable to achieve Medical Device India regulatory compliance to obtain manufacturing or Import license. The new India regulatory requirements are much complex, experts in the field can take solid regulatory strategy and execution plan. Team of regulatory affairs member from client organization in consultation with I3CGLOBAL team of experts will often have lead responsibility for developing the regulatory strategy.

Test license

For the purpose of clinical investigations or test or evaluation or demonstration or training, the manufacturer or importer apply for a test license to Central Licensing Authority. However, to ensure the safety and performance of a medical device, as per the regulatory requirements, the manufacturer must apply for a test license before submitting the complete application.

Manufacturing License

The manufacturing license application process depends on the risk classification of medical device. Low risk medical devices, classified as Class A & Class B, applications submitted to State licensing authority, whereas for the Class C & Class D medical devices, which are considered as higher in the risk category, it is the Central Licensing Authority.

 

Irrespective of the risk classification of medical devices, every manufacturing unit situated in India, must have the quality management system as per the fifth schedule of India MDR. Class A and Class B medical devices units audited by any Notified Body, which are registered with CDSCO. For Class C & Class D, it is either by a team of officers from CDSCO accompanied by experts or by any Notified Body, if requires.

Import License

Import license applications for all the medical devices will be cleared by Central Licensing Authority. Depends on the risk classification of the medical device the application fees varies. Importers must have an authorized representative in India to get an import license. Having an approval in any of the GHTF countries considered as an advantage in the approval process.

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