Medical Device Registration

The National Regulatory Authority (NRA) of India is the central drugs and standard control organization (CDSCO) under the Directorate General of Health Services, Ministry of Health and Family Welfare, and Government of India.

Medical devices and IVD (In-Vitro Diagnostics) sold in India are governed by the CDSCO (Central Drug Standard Control Organization). 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 a mandatory requirement.

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 managed under the Medical Device Rules, there is currently a proper system for medical device registration in India. So it is utmost necessary to follow rules and regulations in procuring medical device registration in India.

But before proceeding it is important to know the types of medical devices.

Classification of Indian Medical Device

There are 38 types of medical devices in India, which are categorically classified into 4 classes. They are done in accordance with the risk associated with the device. Below table illustrates the division.

Who may submit an Application on CDSCO Medical Device Registration in India?

The list of individuals who may apply for CDSCO Medical Device Registration in India is as follows:

1. Manufacturer's who has a  registered office in India;
2. The Manufacturer's Authorized Representative;
3. The Manufacturer's Affiliate;
4. Any Additional Importers
5. Domestic Producer.

Do Medical Devices Require Registration In India?

According to the notification sent out on July 11, the vast majority of medical devices which fall in class A and B in India would be subject to licensing requirements starting on October 1. The full timeline of medical device registration is illustrated below:

• No registration or license will be necessary from April 1, 2020 to September 30, 2021 to produce, import, distribute, or sell newly notified medical devices;
• October 1, 2021 to September 30, 2022 - Registration will be necessary, but no license will be necessary, to import or manufacture such medical devices;
• Class A or Class B medical device manufacturing, distribution, and sale from October 1, 2022, to September 30, 2023 will require a license. Nevertheless, Class C or Class D manufacturing, distribution Medical devices in class D.
• Class C and Class D medical device manufacturing, importation, distribution, and sale will all require a license starting on October 1, 2023.

All producers were advised by the health minister to register their medical gadgets within the allotted period. Manufacturers who don't register their products risk fines, and according to the regulations, unregistered products aren't considered authorized.

Documents Required For Medical Device Registration in India

1. Form 40
2. ISO 13485 certificate
3. Quality Assurance Certificate
4. CE Design Certificate
5. An Undertaking that all information provided is deemed authentic
6. Either a Free Sale Certificate or Certification from the Foreign Government
7. Certificate of Marketability from GHTF (Australia, Canada, Japan, the European Union, and the United States);
8. Plant Master Report
9. Device Master File

Medical Device Registration Process in India

For medical device registration process, adhere to these steps:

Step 1: Submit Form 27 to the SLA (State Licensing Authority) together with the fee in the form and manner specified in the proposed Rules and a copy to the DCG Office in order to apply for a license to manufacture these notified devices in India.

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:

A.) Specs Regarding Manufacturing:

1. General information, including names, addresses, and the locations of the manufacturing facilities and the manufacturer's registered offices;
2. A succinct proposal outlining the company's strategy, a product that will be made, their viability, and other key profiles;
3. A duplicate of the site master file
4. Specifics of the standards that the business follows for product inspection and good manufacturing practices;
5. Copies of any ISO or other certificates that the company has achieved for its manufacturing facilities, if necessary;
6. A thorough description of the gadgets to be manufactured production process;

B) Details regarding the Product

1. Private label
2. Device class
3. Use of strategy and intended application
4. Details regarding the materials utilized
5. Variations in the device's design, dimensions, or shape, if any;
6. Suggested storage circumstances;
7. Warnings, restrictions, safety measures for potential negative effects, and alternative therapies, as appropriate;
8. Brief suggestions of any issues that have been reported;
9. The elements' quantitative and qualitative characteristics;
10. A list of the devices, equipment, and accessories that will be used with the device. further details on the product's description, including any accessories included with it;
11. Pack sizes are included in the packaging description;
12. Labeling information that complies with the 1945 Drugs and Cosmetics Rules;
13. English-language promoted materials and medical manuals;
14. The device's use in a particular medical field;
15. The manufacturing units have testing facilities accessible.
16. The product availability.

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 authorization to commercialize the device.

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

Step 8: Following proper CLAA clearance, the license will be given in accordance with Form 28 of the aforementioned guidelines.

Regalguru: Medical Device Registration Consultants in India

As a one-stop shop for services, Regalguru guarantees a simple registration process for CDSCO. Regalguru provides end-to-end regulatory compliance solutions for all of India.

1. Free advice on whether a medical equipment complies with medical device regulations
2. Help with preparation and management
3. Documents
4. Application completion
5. Coordinating with the department's representatives on
6. On the applicant's behalf
7. Timely clearance with an ETA specified
8. Excellent service for a reasonable price.