Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
ARQon Pte. Ltd.
Singapore (HQ), Malaysia, Vietnam, Indonesia, Philippines, Thailand, Taiwan, Hong Kong, South Korea, Switzerland, USA, Australia, New Zealand, Rwanda, India, Sri Lanka
We are a premier regulatory consultancy firm specializing in medical devices, in-vitro diagnostics (IVD), and pharmaceuticals. Founded in 2014, the company offers a comprehensive suite of services ranging from product development strategy and clinical trials to product registration and post-market surveillance. With a team of experts possessing vast experience in regulatory authorities and industry, we bridge the gap between scientific innovation and regulatory compliance, ensuring patient safety while fostering medical advancement. The company also provides unique business matching services through its ATTOPOLIS platform and training through the International Medical Device School.
Regulatory Compliance Associates Inc. (RCA)
Pleasant Prairie, WI, Tampa, FL
Regulatory Compliance Associates (RCA) is a leading global provider of regulatory and compliance expert consulting services for life science companies. The company offers expertise in regulatory affairs, assessments and audits, agency response, preparation and remediation, and new product development support for medical devices, pharmaceuticals, and compounding pharmacies.
Emergo by UL
USA, Canada, Brazil, Australia, China, Hong Kong, Taiwan, India
A dedicated partner for medical device and IVD manufacturers, we offers deep local regulatory expertise through its offices in over 20 global locations. Services include product registration, human factors research, clinical strategy, and local in-country representation to ensure rapid, compliant market access worldwide.
July 1, 2025
Approximately 5 minutes
India's Central Drugs Standard Control Organisation (CDSCO): Regulator, Compliance, and Market Access
India's Central Drugs Standard Control Organisation (CDSCO)
The Central Drugs Standard Control Organization (CDSCO) is the National Regulatory Authority (NRA) and the primary body responsible for regulating all medical devices, IVDs, and drugs in India. Based in the Ministry of Health & Family Welfare, the CDSCO oversees the entire lifecycle of medical devices, from import and manufacture to sale and distribution, ensuring compliance with standards for safety, quality, and efficacy.
⚙️ Role in Medical Device Registration
For foreign manufacturers, the CDSCO is the issuer of the required market authorization: the MD Form 15 Import License. This license is site-specific, meaning a manufacturer with multiple production facilities will require a separate MD-15 for each site.
- Application Process: The Import License is granted upon approval of the MD-14 application, which requires the submission of a Plant Master File (PMF) for the manufacturing site and a Device Master File (DMF) for the product.
- Compliance Checks: The CDSCO conducts inspections and audits to ensure manufacturing facilities comply with quality system regulations (e.g., ISO 13485).
📈 Significant Regulatory Updates
The CDSCO has been actively reforming its regulations, primarily through the Medical Device Rules, 2017 and subsequent amendments, to expand its regulatory scope:
- Mandatory Import Licenses: As of October 1, 2023, all Class A (Measuring/Sterile), Class B, Class C, and Class D devices require an MD-15 Import License for importation. Class A Non-Measuring/Non-Sterile devices are exempt from the Import License process but still require mandatory online registration and self-certification.
- Online Registration Portal: The launch of an online registration portal has streamlined the application submission process.
- New Rules: The introduction of the Medical Device Rules, 2020 replaced the 2017 rules (in part), further clarifying the regulatory landscape.
⚠️ Compliance and Market Access
To successfully enter and operate in the Indian market, foreign companies must work with a local entity (the License Holder) to ensure ongoing compliance:
- License Holder Responsibility: The local License Holder is the official interface with the CDSCO and is responsible for managing the Import License, handling customs clearance, and coordinating Post-Market Surveillance (vigilance and adverse event reporting).
- Inspections: The CDSCO performs inspections and audits to verify compliance with safety and quality regulations.
Related Articles
Approximately 5 minutes
India IVD Device Registration: Classification, Import License (MD-15), and Local Testing
In-Vitro Diagnostic (IVD) devices in India are regulated by CDSCO under the MD Rules, 2017, and are classified by risk (A-D). Higher-risk IVDs (Classes B, C, D) require an MD-15 Import License based on submitted Plant and Device Master Files (PMF/DMF) and mandatory local performance evaluation for high-risk kits.
Approximately 5 minutes
India Medical Device Registration: Requirements for Import License (MD-15) under MD Rules 2017
India's CDSCO regulates medical devices under the Medical Device Rules, 2017. Imported Class B, C, and D devices require an MD-15 Import License, necessitating submission of a Device Master File (DMF) and Plant Master File (PMF) via a local License Holder.
Approximately 5 minutes
India Medical Device Classification: Risk-Based System under Medical Devices Rules 2017
India's CDSCO classifies medical devices based on risk (Class A to D), intended use, and invasiveness, adhering to the MDR 2017 Guidance. This system is crucial for determining registration requirements, with higher-risk classes (C and D) needing an Import License (MD-15) and a more rigorous review.
Approximately 5 minutes
India Medical Device Grouping: Maximizing Efficiency under MDR 2017 Guidance
India's CDSCO allows grouping of related medical devices (Family, System, Group, IVD Kits/Clusters) for registration under the MDR 2017 to simplify the application process, save costs, and reduce review time by submitting a common Device Master File (DMF).
Approximately 5 minutes
India Medical Device Local Labeling Requirements: Compliance Before Customs Clearance
Medical device labeling in India must comply with the Medical Devices Rules, 2017, and Legal Metrology Rules, 2013, with India-specific details (Importer contact, Registration Number, MRP) applied *before* Customs clearance. Electronic Instructions for Use (eIFUs) are accepted.
Approximately 5 minutes
India Medical Device Advertising Rules: Compliance with Approved Intended Use and UCMPMD
Medical device advertising in India must align strictly with the CDSCO-approved intended use (Form MD-15). Although a formal pre-approval process is lacking, compliance is enforced by the Drugs and Magic Remedies Act and the mandatory self-regulation under the Uniform Code for Marketing Practices in Medical Devices (UCMPMD).