In India, the regulation of medical devices and in vitro diagnostics (IVDs) is overseen by the Central Drug Standard Control Organization (CDSCO). The Medical Device Rules, 2017, which took effect on January 1, 2018, initially applied to 37 specific medical devices. However, the regulatory scope has since broadened, requiring all medical devices and IVDs to be classified and to obtain an Importer License under Class A, Class B, Class C, or Class D for sale in the Indian market.

For Class C and Class D medical devices and IVDs not included in the original list of 37 regulated products, the CDSCO extended the compliance deadline to September 30, 2023, for meeting licensing requirements.

In India, the Authorized Indian Agent functions as the Legal Importer of medical devices. To obtain this designation, the agent must complete and submit Form MD-14 SUGAM portal. Once the CDSCO approves the application, an MD-15 Import License is granted. As a result, the MD-15 license holder is officially recognized as the Importer of the medical device in India.

To apply for the Import License, the following steps must be completed:

1. Authorize the Indian Agent with Power of Attorney.

2. Complete the MD-14 Application form on the SUGAM portal through the Indian Agent.

3. Submit the necessary documents based on the device classification once the MD-14 form is generated.

4. Pay the required fees.

5. Respond to any queries from the regulatory authorities.

6. Undergo a review by the Medical Device Advisory Committee (MDAC) for novel products.

7. Obtain the Import License using Form MD-15.

8. Begin the process of exporting the medical devices to India.

The article Medical Device Registration in India describes the CDSCO’s procedure for registering medical devices.

When applying for the Indian license, specific documents must be prepared according to the format provided by the CDSCO:

1. Device Master File: This document is equivalent to the Device Technical File.

2. Predicate Table: This table outlines devices that are substantially equivalent, as described in the Clinical Evaluation Report.

The remaining required documents are typically available if the manufacturer has approval from a Global Harmonization Task Force (GHTF) country. The table below lists the requirements based on the classification, allowing manufacturers to leverage their existing documents when applying for the MD-15 Import License.

Once the dossier is submitted, and all queries are addressed to the CDSCO’s satisfaction, the MD-15 Import License is granted. The manufacturer must then adhere to post-approval compliance requirements, including updates to the device and manufacturing site as stipulated by the Import License conditions. This ensures the license remains valid indefinitely, with the manufacturer needing to pay retention fees every five years, simplifying the license renewal process. Failure to maintain these compliances would necessitate the manufacturer to undergo the entire registration process again.

Why Morulaa as your Import License Holder:

The Role of the Importer in India requires a knowledgeable firm which has experience not only in the Medical Device Rules, 2017 but also in working with the Indian Customs. By selecting Morulaa, you will have access to the single largest Independent Importer in India.

Choosing Morulaa as your Import License Holder offers several benefits:

• Partner with multiple distributors.

• Protect sensitive information on your device’s technical file and manufacturing processes.

• Ensure post-approval compliance to minimize supply chain disruptions.

• Maintain independence at minimal cost.

It’s important to remember that depending on your product type, additional specific licenses may be required when registering medical devices in India. Examples include (but are not limited to) the Electronic Waste Disposal License, BIS Certificate for batteries supplied with medical products, PC & PNDT certificate for ultrasound devices, and certification from the Atomic Energy Regulatory Board for X-ray and other radiation-related products.

An Independent Importer helps simplify labeling requirements, manage inventory in India efficiently, and ensure last-mile delivery across various regions of the Indian subcontinent. Whether you are launching products in India, transferring licenses, or changing distribution partners, appointing Morulaa as your Authorized Indian Agent allows you to leverage our expertise to minimize supply chain disruptions.