How to get Medical device registration in India?

With advancing medical technology, the medical device market is expected to grow over the next several years due to increased health awareness, a growing middle class, and government health initiatives. The medical device registarion process in India is overhauled in 2017 with the publication of the Medical Device Rules.The rules came into force in January 2018 and devices are regulated by the Central Drugs Standard Control Organization (CDSCO), an agency of the Ministry of Health and Family Welfare. today there are registration procedures for certain types of medical devices regulated under the Medical Device Rules. While the list of regulated products is specific, the CDSCO occasionally adds products to the list. Determining if your product is regulated by the CDSCO is the first step marketing entry in India.

Process for Medical device registration in India

Through the notification dated February 11, 2020 the Government has mandated the registration of all devices, except for the notified categories, through the procedure set down in Chapter IIIA of the Rules. In effect, combined with the amendment of the definition, all Medical devices require registration for manufacture and import from April 1, 2020 onward.

Classification of Medical Devices

At present, approximately 40-50 Medical device registeration in India, are done and those are notified, and there is no formal classification of the different types of medical devices for these devices. However, the categorization that  will be available in future is as follows:

Class A – Low Risk Medical Devices such as thermometers and tongue depressors

Class B – Low-moderate Risk Medical Devices such as hypodermic needles and suction equipment

Class C – Moderate-high risk Medical Devices such as lung ventilator and bone fixation

Class D – High Risk Medical Devices such as heart valves and implantable devices

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If  You Want Medical Devices Services Consultation For Following.

    1.     Medical Device Manufacturing

    2.     CDSCO Registration

    3.     FDA 510 k clearance

    4.     Continuous Improvement Program

    5.     Design Control Requirements

    6.     QMS Certification Services

    7.     Manufacturing Plant Layout Design

    8.     Primary Packaging Consultant

    9.    Manufacturing Site Conceptualization

 10. Combination Product

 11. Medical Device Design And Development 

 12. Clean Room Design Consultant

 13. ISO 13485 Certification

 14. ISO 15378 certification

 15. Medical Device Process Validation

 16. 21 cfr part 820

 17. 21 cfr part 210 and 211

 18. DMF submission

 19. CAPA Management

 210. TURNKEY PROJECT CONSULTANT