India is a potential global hub for medical devices. Increase in awareness, longevity, and supportive government policies are some of the factors fuelling the demand for medical devices. Hence, entities are trying to tap into the potential of the Indian medical device market. Indian medical devices regulations are in place to control the quality, safety, and efficacy of medical devices. Medical device companies need to abide by the medical device regulations in India. The regulations are confusing and difficult to comprehend. Are you confused about the Indian regulations for medical devices? Well, look no beyond.

You have landed at the right place. To help you with your CDSCO medical device registration queries, we have curated some frequently asked questions in this blog.

Common queries regarding Indian regulations for medical devices

1) What is the apex body for medical device regulations in India?

The Central Drugs Standard Control Organization (CDSCO) is the apex body for medical device regulations in India. The CDSCO functions under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India.

2) What are the laws for Indian regulations for medical devices?

The Drugs & Cosmetics Act govern the regulation of drugs, cosmetics, and medical devices. The manufacture, import, sale, and distribution of medical devices in India are monitored and controlled under this act. Specifically for medical devices, the Medical Devices Rules 2017 (effective 1st Jan 2018), Medical Devices (amendment) Rules 2020 (effective 1st Apr 2020), and amendments thereof have been implemented.

3) Are all medical devices regulated under Medical Devices Rules 2017?

All notified medical devices to be marketed in India are regulated under Medical Devices Rules 2017. This was stated in the notification S.O. 648 (E) dated 11.02.2020.

4) Are all medical devices manufactured for animal use only regulated under Medical Devices Rules 2017?

Medical devices intended for animal use only are also regulated under Medical Devices Rules 2017.

5) Does a software used for medical purposes require CDSCO registration?

As per Indian medical devices regulations, if a medical device software falls within the purview of Medical Devices Rules, 2017, S.O. 648 (E), then it needs a CDSCO registration.

6) What are the CDSCO medical device classes?

For the ease of CDSCO medical device registration, the apex body has classified medical devices into four classes. The classification is based on risk level and intended use. The medical device classes are Class A (low risk), Class B (low to moderate risk), Class C (moderate to high risk), and Class D (high risk). The classification system helps with the Indian medical devices regulations.

7) What is considered a “new medical device” in India?

As per Indian regulations for medical devices, a “new medical device” is a medical device without a predicate medical device registered/approved in India.

8) What is considered a “predicate medical device” in India?

A “predicate medical device” is a device which is registered or approved in India. As per Indian medical devices regulations, the predicate device should have the same intended use, design characteristics, and material used for construction as the device which is being proposed for registration in India.

9) What is the accepted language for CDSCO medical device registration application?

The accepted language for CDSCO medical device registration application is English. All documents and the application should be written in English.

10) What is the role of Central Licensing and State Licensing Authorities in CDSCO medical device registration?

• Role of Central Licensing Authority (CLA): CLA regulates and issues licenses for importing all classes of medical device. CLA issues licenses for manufacturing Class C and Class D medical devices. It monitors the clinical investigation and approves medical devices that do not have predicate devices. It approves the registration of notified bodies and laboratories for carrying out test or evaluation. CLA issues test licences for manufacturing or importing all medical device classes. It governs the risk-based classification of medical devices.
• State Licensing Authority (SLA): SLA regulates and issues licenses for manufacture, sale, and distribution of Class A and Class B medical devices.

11) What is the mode and portal for CDSCO medical device registration?

The mode of medical device registration is online. SUGAM is the official portal for online application for CDSCO medical device registration.

12) Does CDSCO provide any support to Start-ups/Innovators/Importers/Manufacturers?

The CDSCO does provide support regarding Indian medical devices regulations to Start-ups/Innovators/Importers/Manufacturers. The CDSCO has the public relation office to address the queries and issues related to medical device regulations in India.

13) What are the supporting documents required for CDSCO medical device registration?

Various supporting documents are required for CDSCO medical device registration.CDSCO has provided a comprehensive checklist of the documents required depending on the application form. Preparation of the supporting documents can be tedious and time consuming. With the support from Pharmadocx Consultants, document preparation can be a breeze. We can help you collate all the documents per CDSCO requirements.

14) What is the fee required for CDSCO medical device registration?

The fee required varies for the various application types. The Second Schedule of Medical Devices Rules 2017 has detailed the fee required for various applications.

15) What are the requirements for the addition of medical devices as an additional product in an existing license?

An endorsement application and necessary supporting documents as per the fourth schedule of Medical Devices Rules 2017 will be required. Also, the specified fees need to be paid.

16) Who audits the manufacturing facility of Class A and B medical devices?

As per Indian medical devices regulations, the notified bodies registered with the CDSCO are competent to perform the audit.

17) What is the waiting period for Class C and D medical device manufacturing facility inspection?

After review of the application and verification of the documents, the Class C and D medical device manufacturing facility inspection is performed. The regulatory body official usually carries out the inspection within 60 days from the date of application.

18) Are there any medical device labelling requirements in India?

Medical device regulations in India have specified medical device labelling requirements. Medical device labelling requirements have been described in Chapter VI of Medical Devices Rules 2017. All devices marketed in India are required to comply with these requirements.

19) How long does it take to secure CDSCO medical device registration?

The timeline varies from case to case and also depends on the application backlog. The usual timeline for processing an application varies from 6 to 9 months. This gets further delayed if the regulatory body raises a query.

20) What is the validity of the Free Sale Certificate?

The Free Sale Certificate issued is valid up to the validity of the manufacturing licence.

21) Do I need to register my medical device with CDSCO in spite of having a USA/EU/UK medical device registration?

As per Indian regulations for medical devices, a CDSCO medical device registration is mandatory to enter the Indian market. The documents required for registering your medical device in India overlaps to some extent with those of foreign requirements. This makes it convenient to register your device in India. Certain overlapping documents for medical device regulations in India are quality management system documents, CE Design, ISO Certificate, etc.

Still have further questions regarding medical device regulations in India?

The Pharmadocx Consultants team will be glad to answer your queries. We have over 27 years of experience in Indian regulations for medical devices. Pharmadocx Consultants can help you secure CDSCO medical devices manufacturing, import, and test licenses. Simply shoot your query to [email protected] or call/Whatsapp on 9996859227 and we will try to resolve it.