Medical Device Registration Service In Chennai

With a significant contribution from device imports, India is currently one of the largest international markets for medical devices. Before, medical device makers in India were free to sell their products wherever. Since 2006, all medical devices entering India must adhere to the CDSCO's Indian Medical Device Regulations. For particular types of medical devices governed by the Medical Device Rules, there is currently a formal procedure for medical device registration in India.

Medical equipment and IVD (In-Vitro Diagnostics) sold in India are governed by the CDSCO (Central Drug Standard Control Organization). The State Licensing Authority (SLA) and CLA jointly hold the approval authority, while the CDSCO is led by the Drug Controller General of India (DCGI) (Center Licensing Authority). Medical device production, import, sales, and distribution in India are governed by the Drugs and Cosmetics Act, 1940 and Rules, 1945. Therefore, in India, CDSCO Medical Device Registration is required.

Which Regulating Bodies in India are Charged with CDSCO Medical Device Registration?

The following are the principal regulatory organisations in India that are in charge of CDSCO Medical Device Registration:

• The manufacture approval of specific pharmaceuticals, such as blood products, vaccines, high volume parenteral, r-DNA derived), specific medical devices, and innovative drugs, is the responsibility of the Drug Controller General of India (DCGI)
• The primary regulating authority for pharmaceuticals and medical devices in India is the CDSCO (Central Drug Standards Control Organization)
• The Drugs & Cosmetic Acts and Rules of India govern the import, sale, manufacture, and distribution of medical equipment in that country.

Different Types of Applications for CDSCO Medical Device Registration in India

A website called SUGAM is where all applications for CDSCO Medical Device Registration in India (for both Notified and Non-Notified Devices) must be uploaded, and this is also where CDSCO manages the applications

• Devices that are not on the list of Notified Devices are not subject to regulation in India. However, a list of these devices will be posted on CDSCO's official website. To commercialise these products, foreign or overseas manufacturers must have an IAA based in India.
• Devices that have been notified: The CDSCO is in charge of the 37 different device categories that are listed in the Notified List. The CDSCO must also be notified in advance before marketing any of these devices in India. When submitting an application for CDSCO Medical Device Registration, there are various application kinds, and each has its own set of paperwork requirements.

Manufacture of Medical Devices - CDSCO Medical Device Registration in India

Step 1: You must submit an application for a licence to manufacture certain notified devices in India .

Form 27 must be submitted to the SLA (State Licensing Authority) together with a copy to the DCG Office and the fee in the manner and form specified in the proposed rules.

Step 2: From the moment these rules were published, applicants would have 60 days to submit their applications for manufacturing.

Step 3: No production will be allowed moving forward without the competent authority's approval in accordance with the standards set in the case of devices belonging to the aforementioned categories that had not been produced in the nation before the notification date.

Step 4: When submitting an application to the licencing body, the applicant must provide the following information:

Details Of Manufacturing:

1. a general description, including the names and addresses of the company's directors as well as the locations of its manufacturing facilities and registered offices

2. A succinct project illuminating the company's plan, a made device, their feasibility, and other key profiles

3. a duplicate of the site master file

4. Specifics about the company's criteria for product inspection and Good Manufacturing Practices

5. Copies of any ISO or other certificates that the business has achieved for its manufacturing facilities, if necessary

6. An explanation in detail of how the intended production of the devices will be carried out

7. The technical staff members whose qualifications, backgrounds, and names will be used to produce the devices

Details Of The Product:

01. A brand or a proprietary name

02. Type of device

03. . The use process and the intended use

04. A succinct explanation of the apparatus

05. Materials utilised and their specifications

06. Modifications to the device's design, dimension, or shape, if any

07. Recommendations for storage

08. Where appropriate, warnings, contraindications, precautions for anticipated negative outcomes, and alternative therapies

09. Brief descriptions of any issues that have been reported

10. Specifications of the constituents' qualities and quantities

11. A list of the equipment or accessories that must be used with the device. further details on the product's description, including any accessories included with it

12. A description of the packaging including pack sizes

13. Labeling information that complies with the 1945 Drugs and Cosmetics Rules

14. English-language promotional materials and medical manuals

15. The device's use in a medical specialty

16. The production units have testing facilities accessible

Step 5: Expert committees must be established to thoroughly review the information provided by the applicant for the device evaluation in order to study medical devices that are either new or lack benchmark certification

Step 6: The committee submits its recommendation for the acceptability of the device to the appropriate authorities for consideration in granting authorisation to commercialise the device

Step 7: The SLA would submit the licence to CLAA for approval following the joint verification and inspection.

Step 8: After receiving proper clearance from CLAA, the licence will be given in accordance with mentioned rules' Form 28

FAQ

What is a medical device?

As established from time to time by the Central Government of India through a notification in the Official Gazette after consultation with the Board, such devices are for internal or external use in the treatment, diagnosis, mitigation, or prevention of disease/disorder in humans/animals.

What is the function of CDSCO?

The CDSCO is India's main legislative body for controlling and regulating drugs and medical equipment.

What is the time period for the issuance of the Registration Certificate?

The authority must provide the Registration Certificate in Form-41 within 9 months of the applicant's receipt date if the application is complete in every respect and the data listed in Schedules D-I and D-II are accurate.

What is the validity of the Registration Certificate in Form 41 for medical devices?

Its validity period is three years beginning on the date of issuance.

Which regulatory body oversees the entry of medical equipment into India?

The Medical & Diagnostics Division, DGHS, Ministry of Health & Family Welfare, and CDSCO.

Does a medical device need registration in India?

Currently, only 40 to 50 medical devices in India need to be registered, and the Manufacturer should obtain a NOC from the DCGI for any other devices.

What are Class I, II, and III medical devices?

Class I medical devices pose the least amount of risk to humans, Class II devices present a higher level of risk, and Class III devices are the most dangerous.