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Know More About MEDICAL DEVICE REGISTRATION
Introduction and Its Compliance
Medical Device Registration in India is governed by the Medical Devices Rules, 2017, under the Drugs and Cosmetics Act, 1940, regulated by the Central Drugs Standard Control Organization (CDSCO). It mandates that all manufacturers and importers of specified medical devices must obtain registration/licenses to legally sell or distribute their products in India. Lawfinity supports in the classification, compilation and filing of regulatory submissions with CDSCO. We will make sure your medical device measurements meet the necessary standards no matter whether it is a diagnostic tool, an implant or a surgical instrument.
Why It Is Needed
Medical Device Registration is mandatory to ensure the safety, quality and performance of the medical devices that are distributed in India. It aids the government in controlling devices that are entering the health care system so the public won't be put at risk. Lawfinity facilitates the full process of compliance from categorisation of devices, license grant and renewals as well.
Benefits and Advantages
- Legal Market Entry Medical Device Registration ensures that your products are legally permitted to be manufactured, imported or sold in India. It enables manufacturers and importers to tap into one of the largest healthcare markets in the world.
- Regulatory Credibility Products registered with CDSCO are seen as safe and reliable. This enhances brand image and builds confidence among healthcare professionals and end-users.
- Risk Mitigation Proper registration minimizes the risk of legal penalties, product recalls or operational disruptions. It ensures your business is protected under Indian medical regulations.
- Product Traceability & Control Registered products follow defined standards for labelling, packaging and distribution, enabling efficient monitoring, recall and accountability if needed.
- Global Expansion CDSCO registration, especially under WHO-GMP compliance, enhances credibility for export markets, boosting business growth opportunities internationally.
Eligibility Criteria
- The applicant must be a manufacturer or authorized Indian agent of a foreign manufacturer.
- The entity must have a valid manufacturing license (Form MD-5) or wholesale license.
- Importers must possess an Importer Registration (Form MD-14) and Import License (Form MD-15).
- Devices must be classified as per risk categories: Class A, B, C or D.
Documents Required
- Covering letter and application form (Form MD-14/MD-5/MD-7 etc.)
- Device Master File (DMF) and Plant Master File (PMF)
- ISO 13485 certificate and CE Certificate (if applicable)
- Technical documents including safety, clinical evaluation reports and labelling
- Manufacturing/Import License details
- Undertaking and proof of premises
- Power of Attorney (for importers)
- Free Sale Certificate (for imported devices)
- Fees payment receipt as per device category
- Lawfinity ensures all documentation is accurately prepared and submitted to avoid rejections or delays.
Steps
- Classification of Device: Determine the risk category of the device.
- Documentation: Compile all required documents, including technical files.
- Online Application: Submit the application through the CDSCO Sugam portal.
- Inspection (if applicable): Site inspection may be required for certain classes.
- Review & Query Resolution: Address any queries or deficiencies raised by the authority.
- Grant of License: CDSCO issues the device registration or license upon successful evaluation.
- : Lawfinity assists at every stage, ensuring complete compliance and faster approval.
Penalties
- Manufacturing or importing unregistered medical devices in India can lead to penalties including imprisonment up to 5 years and fines of at least ₹1,00,000 or three times the value of confiscated medical devices, according to Business Law Chamber.
- Selling non-compliant or misbranded devices can result in product seizure and business closure.
- Failure to maintain prescribed labelling, packaging or documentation may lead to cancellation or suspension of registration.
- Repeated violations may attract prosecution or blacklisting from CDSCO.
Timelines
Class A & B
Approximately 45 to 90 working days.
Class C & D
Around 4 to 6 months, depending on inspection and review time.
Our services include guidance, documentation support, and application facilitation. It is important to note that we are not a government department, not a government-run website, and not affiliated with any government authority in any capacity. The role of lawfinity.in is purely that of a professional consultant.
Fee
Frequently Asked Questions
Because every great business starts with the right answers.
Devices notified under Medical Devices Rules, including diagnostic kits, surgical instruments, implants and certain digital health equipment.
Yes, though Class A devices are registered by State Licensing Authorities, registration is still mandatory.
The license is generally valid for 5 years, subject to retention and renewal fees.
No. Foreign entities must appoint an Indian Authorized Agent to represent them in the application process.
Yes, for moderate to high-risk devices (Class C & D), clinical evidence and performance evaluation may be required.
While ISO 13485 certification is not compulsory, it is highly recommended and often required to demonstrate quality compliance.
Devices are classified based on risk: Class A (low risk), B (low-moderate), C (moderate-high) and D (high risk).
Only if they are of the same category or product family. Otherwise, separate applications are required.
Yes, Lawfinity offers ongoing support including renewal, modifications, labelling compliance and recall assistance if needed.
Voices of Success
Hear from those who have thrived with us and discover how businesses have transformed and grown with our expert guidance and support.
Anil Yadav
Shaperz India Grain Private Limited
“From FSSAI to Trade License, Lawfinity handled all our approvals efficiently. One-stop solution for all licensing needs.”
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