Regulatory Requirements for Entering the Indian Healthcare Market:
CDSCO Overview
Indian Authorized Agent Requirements
The Indian healthcare market is rapidly becoming an attractive market for medical device manufacturers. The Central Drugs Standard Control Organization (CDSCO) is governed by the Drugs and Cosmetics Act (1940) and Rules (1945) and is responsible for regulating drugs, cosmetics, medical devices and in vitro diagnostics (IVDs) in India.
The Medical Device Regulations, (MDR 2017), in India require that the foreign manufacturers select an Indian Authorized Independent Agent who will act on your behalf in-country representative and as the point of contact for inspection authorities, assist in regulatory application submission, follow-up and approval, labeling compliance, post market changes and vigilance/adverse event reporting to the CDSCO. The authorized Indian agent could be (1) an Independent Agent (2) Direct Subsidiary (3) Local Distributor
Who Can be an Authorized Indian Agent?
- Must be a resident of India with experience in the healthcare industry
- Must hold Drug Wholesale Drug License (Form 20B and 21B/21C) and/or Medical Device Registration Certificate for Sales and Distribution (Form MD-42)
- Holds the Power of Attorney to submit medical device registration documents to CDSCO.
Roles and Responsibilities of an Authorized Indian Agent:
- The authorized Independent agent, in-country representative will review your documents and determine the risk class, grouping and the regulatory pathway of your medical device in India as per Medical Device Regulation, 2017 (MDR, 2017).
- The authorized Independent agent or the in-country representative will support in preparing the predicate device analysis, technical file and other documents.
- Upload the complete dossier on the online SUGAM portal and pay the government fee on behalf of the manufacturer.
- Support in replying to the queries and getting approval to import in India
- The authorized Independent agent, as the in-country representative, will be the “registration holder and Importer”. Hence, their mailing address and contact details are used for device submissions to allow the CDSCO to liaison with overseas manufacturers with no local presence in India.
- Provide documents for inspection and review as and when requested by the CDSCO on behalf of overseas manufacturers.
- Coordinate and report adverse events, product recalls, post market surveillance (PMS) data as the in-country representative.
Why is it Beneficial and Cost Effective to Have an Independent Authorized Indian Agent?
While the CDSCO can grant multiple licenses for medical devices in India as per the MDR 2017, there are practical challenges to consider,
- During the dossier compilation process mandated by the CDSCO, it may be necessary to disclose design information to the distributor. However, since the distributor's primary focus is on sales and marketing, involving them in regulatory affairs as the in-country representative could divert their attention and become an additional distraction.
- In case multiple distributors are holding the import license, each license registration requires the full submission of fees and documents as per the CDSCO’s relevant checklist. This not only increases costs but also adds to the regulatory department's workload, with more paperwork and time spent handling queries from distributors, who may vary in their understanding of the CDSCO's compliance process guidelines.
- India-specific labeling, as mandated by the CDSCO, must be completed when shipping products to India. An independent license holder allows for a single, uniform label for all shipments, avoiding the sensitive issue of which distributor's name appears on the label.
- During the Special Expert Committee (SEC) review having an experienced Independent Agent guide you through the presentation can ensure a smooth meeting and approval.
- An independent agent or the in-country representative also serves as a single control point for customs clearance at the port, ensuring a consistent Customs House Agent (CHA) familiar with your products.
- Single point of contact for managing Post Approval Compliance requirements.
- Incident reporting and recalls can also pose a conflict of interest with distributors under CDSCO guidelines, making an independent agent a more impartial and reliable choice.
- As the product approval certificate is non-transferable (MDR, 2017), if there is a need to change or add a partner in India, the entire registration process, including the payment of government fees, must be repeated. This can result in a lack of product availability, potentially impacting product placement and sales in the market.
Why Choose Morulaa as your Authorized Indian Agent:
- Morulaa is a ISO 13485 certified Independent Authorized Independent Agent as the in-country representative approved by the CDSCO with a dedicated team of regulatory and compliance specialists including Doctorates (PhD) M.Pharm in Pharmaceuticals and Medical Devices.
- Expertise to understand technical dossiers, reading the Clinical Evaluation Reports and supporting manufacturers in building their key files for application and submission to the Indian Authority, CDSCO,as the in-country representative.
- Guidance and Practical Support to prepare for Special Export Committee meetings with the Indian Health Authorities, CDSCO.
- Independent Imports Department having experience and expertise in clearing customs at the local Indian ports at all stages of the importation process.
- Ability to handle from low value to high value and volume consignments and ensure a quick turnaround time with competitive rates for forex, freight, clearing, warehousing and logistics.
To learn more about product registration and processes please Get in Touch with us!