Medical Device Registration process in India

Medical Device Registration process in India before manufacturers of certain medical devices can sell within India they need to be in compliance with India’s medical device regulations. Indian authorities overhauled the medical device regulatory process in 2017 with the publication of the Medical Device Rules. Previously, the medical devices manufacturers were free to sell their products in the Indian market without any regulation. Since 2006, the medical devices imported from overseas locations need to comply with Indian medical device regulations established by CDSCO.

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. For an overview of the regulatory process, see or download the approval chart below. The Medical Device Registration process in India has become more complicated in recent years. In the past, medical devices did not need to be approved at all, but that is not the case today. In India, there are about 30 device “families” that outline which specific medical devices need to be registered.

Classes of Medical Devices

The medical devices in India have been categorized into four classes based on the criticality and risk they offer to the patients.

• Class A: Represent the low-risk category of the products such as thermometers, and tongue depressors.
• Class B: Represent moderate-risk products such as suction equipment and hypodermic needles.
• Class C: Represent moderate-high risk products such as bone fixation and lung ventilator.
• Class D: Represent high-risk products such as implantable devices and heart valve.

Medical Device Registration process in India

The registration process in India for imported devices is a re-assessment largely utilizing the same documentation and evidence required in the reference country review. 

Devices registered during the voluntary registration period benefit from a truncated application that involves administrative documents such as Free Sales Certificate from the country of origin, ISO 13485 certificate, as well as basic product information. The voluntary registration process carries no government processing fees but may be cancelled or suspended by the CDSCO for product safety concerns, or when superseded by the requirement for the mandatory Import License. 

The Medical Device Registration process in India is crucial for distribution purposes. The concerned authority would penalize any manufacturer who wishes to sell the product in unregistered condition.

 Read More - Medical Device Registration process in India

Contact details –

Phone  no -  93702 83428

Mail id – enquiry@operonstrategist.com

Read More Article - 

1. Orthopedic Implants Manufacturing

2. disposable syringe manufacturers

3. Dental Implants Manufacturing

4.Blood Collection Tubes Manufacturing

5.How to start the Manufacturing of Disposable Syringes

If  You Want Medical Devices Services Consultation For Following.

1. Medical Device Consulting 
2. cdsco registration 
3. FDA 510k Clearance 
4. ce mark medical device 
5. CDSCO Manufacturing License 
6. CDSCO import license 
7. TURNKEY PROJECT CONSULTANT 
8. medical device manufacturing 
9. iso 15378 certification 
10. 21 cfr part 210 and 211 
11. ISO 13485 Medical Device Consultant 
12. Primary Packaging Turnkey Project Consultant 
13. Clean Room Design Consultant 
14. manufacturing site conceptualization 
15. Market Analysis and feasibility for Medical Devices 
16. manufacturing plant layout design 
17. medical device design and development 
18. DMF file submission guideline 
19. 21 cfr part 820 
20. qms certification services 
21. capa management 
22. design control requirements 
23. medical device process validation 
24. combination product 
25. continuous improvement program 
26. Medical Device Compliance & Regulatory Services 
27. Cdsco India authorized agent for medical device