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What is a Class B medical device?

Class B this classification is for medium risk in vitro diagnostic devices. A conformity assessment by a Notified Body is required for this classification.

What is a Class A medical device?

The three classes are based on the degree of control necessary to assure the various types of devices are safe and effective. Class I These devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Examples include enema kits and elastic bandages.

What is Type B medical equipment?

Type B (body) equipment is designed to operate within a patients vicinity but without making actual contact with the patient. This classification applies to devices such as x-ray machines, MRI scanners, hospital beds, and LED operating lighting.

How can I get manufacturing license in India?

Procedure To Get A Factory Licence Approach the Directorate of Industrial safety of your state and make an application in Form 1. Most states have introduced an online application for getting a factory licence. Check the official website of the state directorate of industrial safety.

What license is required for medical equipment in India?

Frequently Asked Questions. Do I need to register my medical device in India? Yes, as of October 1, 2023, all Class A measuring/sterile, B, C, and D medical devices require an MD-14/MD-15 Import License with the CDSCO before importing into India.

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