The Long Term Partner in India
For Indian Medical Device Regulatory Compliance
Morulaa HealthTech is the leading firm based in India focusing on Medical Device Registrations, Importation, Logistics and Supply Chain Management across the entire Indian sub-continent. Streamline market entry and ensure continuous supply of medical devices in the Country by partnering with Morulaa. We focus on launching Global Manufacturers into the Indian market with Product approvals with the Central Drugs Standard Control Organisation (CDSCO), Setting up distribution partnerships, Importation and Customs Clearance at the Ports and Supply chain management. We work closely with Manufacturers and their Distribution Partners to navigate the complex regulatory landscape.
Morulaa is a team of like minded individuals with a common goal - making life easy for our customers. Our collaborations are with key companies across the Indian Region for effective delivery of sales and marketing in the Healthcare sector. Our methods enable manufacturers to submit applications to regulators faster and bring products to market on schedule.
Network of over 1000+ Medical Device Manufacturers and Distributors Pan-India
We have over 100 years experience in business. Morulaa is a turnkey solution provider with an in-house regulatory team to conduct registrations of medical device (MD - 14), IVDs, cosmetics, drugs (Form 41, Form 43) in India by following CDSCO. On completing the CDSCO regulation requirements, our marketing team gets involved in the Distributor Selection process. Our regulatory and marketing teams work in sync with our clients to commercialize healthcare products in the Indian medical industry. We have developed a unique model for Product Registration with the Indian FDA (CDSCO) and Distributor Selection to reduce the time frame for the market entrance.
In addition to MD-14 Import License, Morulaa can also assist in obtaining the other relevant licenses such as import license (Form 10), Test License (Form 11) which is successfully import the products into India with registration. As an Indian Authorized Agent, Morulaa provides high quality and professional services and develop long term relationship for the Indian market by the regulation of CDSCO for registration of the product.
- Experienced Team with Strong Understanding of the Nuances of doing Business in India - understanding the Regulatory Landscape and Distributor Work Culture
- Effective Communication - this is much needed when working closely with both the manufacturers and the distributors to discuss approvals, logistics and market dynamics
- Transparent Registration and Importation Process with detailed reporting on costs and duties per shipment.
In India, a local company must be the license holder. Having an Independent Agent hold the license provides manufacturers with the most cost effective and secure way to stay compliant while maintaining commercial independence that fosters strong collaborations with trusted distribution partners.
Yes, now all medical devices require product registration in India. There is a provision for self-certification for Class A non-sterile, non-measuring devices. All others are classified similar to the European MDR Rules as Class A Notified (~Class I Notified), Class B (~ Class IIa), Class C (~Class IIb) and Class D (~Class III).
The documents are similar to what you submit for Registrations in Europe, USA, Canada, Japan, Australia, UK. If you have approvals in one of these countries then you will likely have the Technical File and PMS documents needed for India. The CDSCO Government fees is based on Plant Manufacturing Site and Number of Device Families. While Class A self certified is free, the rest range from US $1050 - US $4500 for a family. The pricing goes up based on the number of products you plan to register.
The timeline is typically between 6-9 months after submission of complete documents. New products lacking strong substantially equivalent devices in the market might have longer processing times. Once granted, the license does not expire provided all post approval changes are updated to the CDSCO promptly.
Medical Device Registration 100%
Independent Authorised Agent 100%
Post Market Reporting 100%
Importation & Customs 100%
Distribution Support 100%
Logistics & Supply Chain Management 100%
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