India Agent Services Marketing Information -

Meet the Regulatory Requirements Seamlessly with an India
Authorized Agent

Medical Devices and IVDs in India are regulated by the Central Drug Standard Control Organization(CDSCO). The Medical Device Rules, 2017, have been in effect since January 1, 2018. Initially, only 37 medical devices were regulated, but now all medical devices and IVDs need to be classified and obtain an Importer License as Class A, B, C, or D to be sold 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 has extended the licensing compliance deadline to September 30, 2023.

Why do you need an Authorized Agent in India?
Are you planning to launch your product or transfer your license to a different Authorized Agent?

Work with Multiple Distributors, Protect Sensitive Information from Channel Partners on your Device Technical File & Manufacturing, Remain Compliant Post Approval to minimize Supply chain Disruptions, Maintain your independence at minimal cost.

The CDSCO requires any manufacturer supplying their Medical Devices & IVDs into India to have a local Indian Representative with registration on the SUGAM portal and to act as a liaison for all communication with the authorities.

At Morulaa, we can help you or your local India Team to navigate the evolving Regulatory Landscape in India and ensure compliance to minimize supply chain disruption for your devices in the Country.
The CDSCO has an extensive list of document requirements which can include sensitive data on your Technical File, Contractors, Design, Audit Reports etc. which you may not wish to share with your commercial partner.
India, the seventh-largest country globally, has 28 states and 8 union territories. To effectively distribute your products across various regions, you may need to work with regional distribution partners. Alternatively, you might choose to establish a local office, sales team, or technical support team. Whether you collaborate solely with channel partners or invest in a local presence, the supply chain in India is primarily managed through a distribution network.
Whether you’re launching your products in India or wish to transfer the license, or select/change distribution partners, by appointing Morulaa as your Authorized Indian Agent, you can maintain your independence in the market at minimal cost.

India CDSCO Regulatory Affairs Support Offered by us for India

Regulatory Pathway	Determine the pathway for Product Registrations in India
Classification	Assist in classifying your medical devices and IVDs Grouping: Guide your team on Product Grouping as Device, System, Family to determine the Fees payable to the CDSCO
Application Form	Creation of the MD-14 Application with special detailing given on brand name, accessories, medical vs non-medical components, shelf life etc. We are uniquely placed in this aspect to have the documentation vetted by experts from the Imports & Logistics Department to ensure that the form created complies not only with the CDSCO Requirements but also so that downstream in 6-9 months on obtaining approval there are minimal roadblocks to the Importation process.
Predicate Comparison	We work with your regulatory team to determine the availability of international predicates in the Indian market. 1.Our experts have in-house experience in supporting you in preparing the Predicate comparison table – this document is critical in determining your pathway in India and if additional clinical studies / expert committee hearing will be applicable on your product.
Queries	Responding to the Queries raised by the CDSCO once the document in submitted and working closely with your team and the government till a decision on approval by the CDSCO is made.

India In-Country Representation for Medical Device and IVD Manufacturers

As your India Authorized Agent, we will

Authorize you to add our Indian Agent Details, local contact numbers on your product labels to maintain compliance with the MDR, 2017
Act as a liaison with the CDSCO post approval for any communication with the CDSCO
Help you determine whether the changes you make to the manufacturing process or device are reportable or not to the CDSCO. If reportable, assist you in preparing the necessary documents.
Help you remain compliant for the 5-year validity of your Registration so that you have an easier experience and faster renewal process.
Cooperate with the competent authorities on preventive or corrective action taken to eliminate or mitigate risks posed by the medical devices.
Inform the manufacturer about compliances or reports our Indian agent receives from authorities, healthcare professionals, patients, or users.
Provide support as required for Post Market Surveillance, Adverse Event Reporting, Recalls etc.

Wondering Why You Need an Indian Importer?

In India, the Authorized Indian Agent also functions as the Legal Importer.

Being an importer in India necessitates a knowledgeable firm with expertise in the Medical Device Rules, 2017, and experience with Indian Customs. Morulaa simplifies labeling requirements, streamlines inventory management, and ensures last-mile delivery across the Indian subcontinent.

An important point to consider when obtaining product registrations in India is that, depending on your product type, you may need additional specific licenses. These may include, but are not limited to, an Electronic Waste Disposal License, a BIS Certificate for batteries supplied with medical products, a PC & PNDT certificate for ultrasound devices, and an Atomic Energy Regulatory Board Certificate for X-ray and other radiation-related products.

We assist you in navigating these additional requirements in India to ensure minimal disruption to your supply chain.

As your Designated Indian Compliance Importer, We Will

Ensure that all medical devices and IVDs being sold in India have India importer-specific labeling, verifying and adding labels as required by the CDSCO.
Determine the duty structure and taxes applicable to your devices.
Assist your channel partners in importing goods at a convenient port and obtaining favorable rates for freight, clearance, and local transportation.
Coordinate with clearing agents and customs authorities to resolve any queries related to imported goods.
Assist in distributing your products to multiple distributors nationwide.
Maintain local supplies for emergency stock requirements of your partners.