The Indian government had recently laid a significant overhaul of its system for regulating medical devices and IVDs. India’s new Medical Device Rules 2017 and its amendments had introduced more formalized regulatory requirements compared to the country’s earlier system.

The salient new features are as follows:

1.Risk-based classification as against similar treatment of all medical devices earlier.

2.Inclusion of all the Medical Devices and IVD’s in the regulated category.

3.Provision of sufficient timeline for registering these newly regulated Medical Devices and IVDs.

4.Release of confirmation on classification of all the Medical Devices and IVD’s for clarification.

Regulatory Strategy report for India

Due to rapid changes in regulations for Medical Devices in India, uncertainty prevails whether the product falls under the Newly notified Medical Devices or earlier Notified Medical Devices and also on which regulatory requirements apply to them.

8C Healthcare develops a Regulatory Strategy Report(s) for your medical devices which enables you to identify and follow the strategy to manufacture/Import and Sell your devices in India.

India is the 4^th largest MedTech market in Asia. The Government of India (GOI) has started various initiatives to strengthen this sector, with emphasis on research and development (R&D) and 100% Foreign Direct Investment (FDI) for medical devices to boost the market. India is  dependent on 75-80% import of medical devices.

Creation of SUGAM online account

In order to submit any application to the Central Drugs Control Organization (CDSCO), an account in the CDSCO’s online portal is required. After submitting the following information in the portal, applicants can login and submit the applications.

• Id Proof Details
• Undertaking
• Corporate Address Proof Details (Certificate of Incorporation)
• Copy of Manufacturing License / Wholesale License

Classification and grouping of medical devices

Before choosing any regulatory pathway for the medical device, the class and group in which the device falls needs to be assessed. For any medical device, Risk based classification would be adopted and the details are covered in Chapter II of Medical Device Rules, 2017.

• Low risk – Class A
• Low moderate risk – Class B
• Moderate high risk – Class C
• High risk – Class D

Based on the category whether the product is the existing Notified Medical device or the newly notified Medical Device and on the classification of the device, the regulatory pathway for the device needs to be followed.

Registration Listing for newly Notified Devices

If the device falls under the category of newly notified medical devices, it requires Registration listing in order to manufacture/Import and sell in India.

Registration Listing is a simplified registration process that regulates the newly added Medical Devices in India. The Medical Device (Amendment) Rules 2020, gives the process of applying for registration listing for these newly notified medical devices.

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTU0OQ==

All the applicants need to upload the below specified information in the official online portal for medical devices.

a)Name and address of the manufacturer

b)Details of the product such as name, Intended Use, Class of the device, Material of construction, etc.

c)ISO 13485 or any other equivalent Certificate

Undertaking stating that the information furnished by the applicant is true and authentic.

For Importation from a foreign country, a Free Sale Certificate is additionally required.

Compilation and submission of Import license application

If the Device falls under the category of earlier notified devices, a manufacturing / Import License is required to manufacture/import and sell the product in India.

Import License application is a complete registration process where the intended device and its manufacturing facility will be registered with the CDSCO. The application documentation requires an undertaking by the manufacturer stating that the manufacturing unit is in compliance with the provisions of the Fifth Schedule of Indian Medical Device Rules, 2017.

Import License would be issued in Form MD-15 and will remain valid in perpetuity, unless it has been cancelled or surrendered. Retention fees for the overseas manufacturing site and the product needs to be paid after completion of every five years (while depositing the retention fees) if there is no major change.

After an Import License is granted, an application to add another device to the existing license is termed as Endorsement application. Products manufactured at the same registered facility can be endorsed to the current Import License by submission of only the products information along with the requisite fees.

Once the Import License is granted, any changes made to the device, its manufacturing process or the manufacturing facility need to be intimated to CDSCO. Depending on the type of change (Major/Minor), specific documentation needs to be submitted which in case of major changes require approval from CDSCO before implementing the change.

Along with the Change Reporting Service, 8C Healthcare also offers the service for Incident Reporting in which all the Adverse events will be informed to CDSCO in a timely manner in order to comply with the reporting requirements.

Ad-Hoc support for obtaining Import license

For all the above-mentioned pathways, service for Ad-Hoc support will also be provided to extend support at any stage of registration process on an hourly basis.

 Indian Authorized agent/Importer service

An authorized agent having a valid wholesale license needs to be appointed by the foreign manufacturer to act on behalf of the manufacturer in India. All the applications of the foreign manufacturer have to be submitted through the authorized agent in their official online account for medical devices.

The authorized agent will be the point of contact to the CDSCO all through the application process and will be responsible for the device in India once the product is imported into India.