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.

The manufacturers can simply submit their applications for grant of registration of the medical device through the CDSCO website

Name of company or firm or any other entity
Name and address of manufacturing site (for devices manufactured in India)
Details of the medical devices (generic name, model no. intended use, class of medical device, material of construction, dimensions (if applicable), shelf life, sterile or non-sterile status, brand name (only if registered under India’s trade mark law).
Certificate of compliance with respect to ISO 13485 standard accredited by National Accreditation Board for Certification of Bodies or International Accreditation Forum in respect of such medical device.
A duly signed undertaking stating that the information furnished by the applicant is true and authentic.
Specifications and standards of medical device (for imported devices only).
Free sale certificate from country of origin (only for imported devices).
After the submission, the registration is completed and the registration number is allotted which is required to be mandatorily printed on the medical devices.
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
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