CDSCO Medical Device Registration in India
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The Central Drugs Standard Control Organization (CDSCO) is responsible for medical device regulation in India as indicated in the Medical Devices Rules, 2017. In India, a medical devices classification is based on risk, ranging from A (lowest risk) to D (highest risk). Registered manufacturers and suppliers of medical devices cover Class B to Class D; moderate to high-risk medical devices and require registration when importing or manufacturing a medical device. Applying for registration will guarantee that a medical device is safety, effective and acceptable quality, and meets all safety and quality assurance requirements established before a medical device can enter the Indian marketplace.
Introduction India’s rapidly expanding healthcare market, estimated at about USD 200 billion in 2023, is expected to grow to USD 370 billion by 2025, offers a significant opportunity for medical device manufacturers and importers. But becoming a part of this rapidly growing market comes with important compliance obligations. Since October 1, 2023, every medical device of every class must be registered with the Central Drugs Standard Control Organization (CDSCO) before you can legally manufacture, import or sell the device in India. The CDSCO registration process may seem overwhelming. It requires a classification process, a lot of documentation, an online application using the SUGAM portal, and an assessment by regulatory authorities. Whether you’re obtaining registration for a low-risk Class A device (e.g., thermometer) or a high-risk Class D device (e.g., pacemaker) being aware of each step will be important for you to be successful.
In this guide which will help you suppliers/manufacturer we cover: ● ● ● ● ●
What constitutes CDSCO medical device registration The different licensing requirements for manufacturers and importers Detailed documentation, forms, and timelines Step‑ by‑ step application process and renewal procedures Post‑ compliance responsibilities and best practices
Let’s dive in and demystify the regulatory journey that ensures both market access and patient safety in India.
What Is CDSCO Medical Device Registration? The central regulatory authority for drugs in India is CDSCO, which is established under the Ministry of Health & Family Welfare, which is the regulatory authority for medical devices in India under the Drugs & Cosmetics Act. CDSCO is responsible for ensuring what medical devices are put on the market in India is safe, quality and efficacy. As of October 1, 2023, all medical devices, whether classified as Class A, B, C, or D, are required to be registered with CDSCO and this requirement applies even if the medical device was notified prior to CDSCO registration.
Why it matters? ● ● ●
Safeguards patients from devices that fail to meet safety or standard Aligns India's healthcare ecosystem with global quality standards Legally required non-compliance and we'll prohibit you or fine you
Classification of Medical Devices (Risk-Based) Proper classification is pivotal to the registration process. CDSCO categorizes devices based on risk: Clas
Risk Level
Examples
A
Low
Stethoscope, bandage, thermometer
B
Low to Moderate
Syringes, BP monitors
C
Moderate to High
Orthopedic implants, catheters
D
High
Pacemakers, ventilators, heart-lung machines
Each class aligns with different licensing authorities and regulatory scrutiny.
Manufacturers vs. Importers a) Manufacturers ●
Class A & B: License granted by the State Licensing Authority (SLA)
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Class C & D: License granted by the Central Licensing Authority (CLA) under the DCGI
b) Importers ●
Required to obtain an import license via CDSCO to sell devices in India
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From October 1, 2022: Import licenses required for Class A & B and notified Class C & D devices
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From October 1, 2023: this extended mandate includes all non-notified Class C & D devices as well
Key Benefits: ●
Market access across India
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Enhanced brand credibility and stakeholder trust
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Compliance with Indian Medical Device Rules, GMP, and regulatory norms
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Competitive edge in public/private tenders
Documents Required for CDSCO Registration Applicants must compile:
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ISO 13485 certification and full Quality Assurance certification
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CE Design Certificate
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Power of Attorney
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Free Sale Certificate
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Plant Master File (PMF) and Device Master File (DMF)
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Post-Market Surveillance (PMS) details
CDSCO Registration Process – Step by Step Device Classification:- Identify device class based on risk, composition, intended use, regulatory certificates, and clinical data. Application Submission:- Use the SUGAM portal to upload application, documents, and pay applicable fees. CDSCO Review:- Authorities may review the submission, audit the manufacturing facility, and/or hire an expert. Approval or Rejection:- If and when you are compliant, the CDSCO will issue the
license; otherwise, you will be told to change something, or told you were rejected.
Forms & Renewal Process Relevant CDSCO forms based on the device class include: For Importers: ●
MD‑ 14 / MD‑ 15 for Class A–D import license
For Manufacturers: ●
Classes A & B: Forms MD‑ 3 / MD‑ 5 (manufacturer's license), MD‑ 4 / MD‑ 6 (loan license)
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Classes C & D: Forms MD‑ 7 / MD‑ 9 (manufacturer's license), MD‑ 8 / MD‑ 10 (loan license)
Renewal: ●
Renew at least 9 months before expiry
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Submit updated PMF and DMF confirming no major changes
Timeline & Validity ●
Processing Time: Approx. 6–9 months, depending on device class and application completeness
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License Validity: Typically five years, unless there is a revocation / suspension
Post-Approval Obligations Once approval is obtained, you must: ● ●
Inform the CDSCO if you change the structure of the company, office address, or manufacturing site's address Make sure that you register if you change any of the details on your registration certificate (and register many months prior to expiry because CDSCO only allows 3 months after terms or registration details change)
Conclusion Navigating your way through the CDSCO registration process can be cumbersome but it is an important milestone not only to access a legal market, but also with regards to patient safety and brand credibility in India’s burgeoning medical device industry. The thorough breakdown is designed to provide manufacturers and importers with actionable information on the classification, documentation, licensing, renewal, and compliance requirements. 🌐https://www.diligencecertification.com/ 🌐+919471642921
