1. Introduction: The Indian Regulatory Maze

India is one of the fastest-growing medical device and IVD markets in the world. Naturally, manufacturers from Canada, Europe, the United States, and ROW are keen to enter Indian medical device & IVD market.

Despite India’s booming medical device market, the regulatory pathway governed by the Central Drugs Standard Control Organization (CDSCO) remains a major challenge for foreign manufacturers. Import license applications MD-14/15 for medical devices and IVDs are frequently delayed, sent into repeated query cycles, or may be rejected altogether. These delays stem from a fundamental misunderstanding of CDSCO’s workflow, documentation expectations, and India-specific regulatory requirements.

At Satori One Click Solutions LLP, we support foreign manufacturers throughout the CDSCO approval journey, from initial pathway assessment to license grant. Based on our hands-on experience with MD-14/15 and MD-41/42 applications, we routinely work with manufacturers to align documentation, regulatory expectations, and local compliance requirements in line with CDSCO’s review process.

Rather than approaching approvals as a paperwork exercise, we focus on clarifying regulatory expectations, structuring submissions in a CDSCO-ready format, and supporting manufacturers through each review stage. Our role includes helping overseas teams understand what CDSCO evaluates at each step, coordinating technical clarifications, and ensuring that applications progress smoothly without unnecessary regulatory complexity.

2. Understanding the Basics: MD-14/15 & MD-41/42

a) MD-14 / MD-15 – Import License for Medical Devices & IVDs

• MD-14: Application for Import License
• MD-15: Granted Import License

This pathway is applicable when:

• The product is already approved in the country of origin
• The manufacturer wants to export finished MDs/IVDs to India
• The device is notified under Medical Device Rules, 2017

b) MD-41 / MD-42 – Wholesale License (India Authorized Agent - India-based entity)

• MD-41: Application for wholesale distribution
• MD-42: Granted wholesale license

As per the Indian Medical Device Rules, 2017 (MDR 2017):

“Authorised agent” means a person including any firm or organisation who has been appointed by an overseas manufacturer through a power of attorney to undertake import of medical device in India and holds a valid MD-42 Licence.”

Note the Common Mistakes

Many companies assume MD-41/42 alone is sufficient for imports. It is not.

For imported devices, MD-14/15 is mandatory, and MD-41/42 supports downstream distribution.

3. Key Regulatory Considerations for US, Canadian, EU & Other Foreign Manufacturers Before Applying to CDSCO

Entering the Indian medical device or IVD market requires more than global regulatory approvals. While prior approvals from regulated markets provide a strong foundation, CDSCO follows India-specific regulatory expectations under the Medical Device Rules (MDR), 2017. Foreign manufacturers should carefully consider the following aspects while planning their MD-14/15 or MD-41/42 applications.

a) Global Regulatory Approvals and India-Specific Requirements

Approvals such as CE Marking, US FDA 510(k), or Health Canada licensing demonstrate product safety and performance; however, they do not automatically translate into CDSCO approval.

India has its own regulatory framework, which includes:

• India-specific labelling requirements (MRP declaration, manufacturing date format DD/MM/YYYY, importer details, etc.)
• Local stability or performance data requirements for certain product categories
• Mandatory Test Licence requirements in applicable cases
• Independent risk classification under MDR 2017, which may differ from EU or North American classifications

From a planning perspective, global approvals should be viewed as supporting documents rather than substitutes for Indian regulatory compliance.

b) Appointment of an Authorized Indian Agent – A Mandatory Regulatory Link

Under MDR 2017, every foreign manufacturer must appoint an Authorized Indian Agent (AIA) through a valid Power of Attorney.

The Authorized Indian Agent acts as:

• The official communication bridge between CDSCO and the overseas manufacturer
• The legal representative for application submission and compliance
• The responsible entity for responding to regulatory queries and post-market obligations

Since CDSCO does not communicate directly with foreign manufacturers, the competence and regulatory understanding of the Authorized Indian Agent plays a critical role throughout the approval lifecycle.

c) Alignment of Plant Master File (PMF) and Device Master File (DMF)

CDSCO places strong emphasis on structured and aligned documentation.

• PMF focuses on the manufacturing facility, quality management systems, infrastructure, and process controls
• DMF focuses on the medical device or IVD itself, including design, intended use, materials, validation, and performance data

A common regulatory challenge arises when:

• A PMF is submitted where CDSCO has requested a DMF, or vice versa
• Information provided in the PMF does not fully align with details mentioned in the DMF

Unlike some global regulators, CDSCO does not assume document equivalence. All documentation must be clearly aligned with MDR 2017 requirements.

d) Consistency Across Regulatory Documents – A Critical Review Expectation

Even small inconsistencies across documents can extend the review cycle.

Typical examples include:

• Product model names differing between DMF and PMF
• Manufacturing addresses not matching between PMF and Free Sale Certificate
• Variations in legal manufacturer name across certificates and application forms

To support smooth technical review, consistency should be maintained across:

• Free Sale Certificate
• CE/FDA/Health Canada certificates
• DMF and PMF
• CDSCO application forms

This alignment supports regulatory clarity and reduces the likelihood of repeated clarification cycles.

e) Timelines – How the CDSCO Review Process Typically Progresses

Manufacturers often plan market entry timelines based on published CDSCO guidance. In practice, approvals progress through defined regulatory stages.

After submission of an MD-14/15 or MD-41/42 application:

• The file enters a technical review queue
• Initial CDSCO communication is typically received within 45–90 days, focusing on documentation completeness and regulatory alignment
• Clarification responses often require coordination with overseas regulatory, quality, and manufacturing teams, which can extend response preparation time
• Post-response, applications undergo secondary review, which may result in approval or additional clarification rounds

While CDSCO indicates a theoretical approval window of 9–12 months, first-time applicants commonly experience a practical approval timeline of 12–18 months, reflecting the structured review process rather than any single delay factor.

f) The Role of the Authorized Indian Agent Beyond Submission

The Authorized Indian Agent’s role extends well beyond uploading documents on the CDSCO portal.

The agent is responsible for:

• Accurate application filing
• Technical and regulatory clarification responses
• Legal accountability under MDR 2017
• Ongoing post-market compliance coordination

From a precautionary perspective, manufacturers should ensure their Authorized Indian Agent has strong MDR 2017 knowledge, technical documentation understanding, and hands-on experience with CDSCO interactions. This helps minimize repetitive queries and ensures smoother regulatory communication.

5. Practical Steps to Keep Your CDSCO Application on Track

While CDSCO approvals follow a defined regulatory structure, proactive planning and structured execution significantly improve application flow. The following measures help foreign manufacturers maintain regulatory clarity at each stage of the process.

a) Pre-Submission Readiness

Before filing an MD-14/15 or MD-41/42 application, manufacturers should ensure:

1. Clear confirmation of product categorization (Medical Device vs. IVD under MDR 2017).
2. Appointment of a knowledgeable and experienced Authorized Indian Agent.
3. Thorough alignment between Device Master File (DMF) and Plant Master File (PMF).
4. Proper notarization/apostille of foreign regulatory certificates and supporting documents.
5. Preparation of India-specific labelling and Instructions for Use (IFU) in line with MDR requirements.

This preparatory phase forms the foundation for smoother technical review.

b) During the Review Process

Once the application is submitted:

• CDSCO queries should be addressed with precise, technically aligned responses.
• All communications should flow through the Authorized Indian Agent to ensure regulatory consistency.
• Application progress should be actively monitored through the CDSCO online portal.

Structured coordination between the overseas manufacturer and the Indian Agent helps avoid unnecessary clarification cycles.

c) Post-Approval Compliance Considerations

Regulatory responsibility continues after license grant:

• MD-15 (Import License) and MD-42 (Wholesale License) are valid for five years and require timely renewal.
• Adverse events must be reported through the Authorized Indian Agent as part of post-market surveillance obligations.
• Any changes related to manufacturing site, product specifications, or intended use must be formally notified to CDSCO.

Ongoing compliance ensures long-term market continuity in India.

6. How Satori One Click Solution LLP Solves These Problems

At Satori One Click Solution LLP, we function as regulatory partners—supporting manufacturers across planning, submission, and lifecycle compliance, rather than acting as mere document filers.

1. Our Import License Support Includes:

• Appropriate regulatory pathway selection (MD-14/15 and MD-41/42 alignment)
• Device classification as per Indian MDR
• DMF & PMF gap assessment and alignment
• Structured handling of CDSCO queries, including response drafting
• India-specific labelling and compliance review

2. Authorized Indian Agent (AIA) Services

• Represent foreign manufacturers before CDSCO
• Handle all CDSCO communications, follow-ups and clarifications
• Support post-approval compliance and regulatory obligations

3. CDSCO Liaison & Regulatory Strategy

• Practical, experience-based timelines
• Pre-submission readiness and compliance checks
• Reduced query cycles

We have supported manufacturers from Canada, the EU, and India across medical devices and IVDs with a strong emphasis on compliance, clarity, and predictable regulatory progress.

📩 Need Expert Support?

Reach out to Satori One Click Solution LLP for:

• Import License support (MD-14/15)
• Wholesale License (MD-41/42)
• Authorized Indian Agent (AIA) services
• End-to-end CDSCO regulatory consulting for Medical Devices & IVDs

📞 Call / WhatsApp: +91 9829098077
📧 Email: satoriocs@gmail.com
🌐 Website: www.satoriocs.com

Because in India, regulatory compliance is not just a requirement—it’s a strategic advantage.