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India Medical Device Registration
Medical device product registration in India is overseen by the Central Drugs Standard Control Organization (CDSCO), under Directorate General of Health Services in the Ministry of Health & Family Welfare. The CDSCO serves as the National Regulatory Authority (NRA) of India.
Medical Device Status
Effective April 1, 2020, the status of a medical device expanded beyond the 23 previously notified medical devices, requiring that all medical devices be registered under The Drugs and Cosmetics Act of 1940.
The CDSCO fees for application processing depend on the device classification. Regardless of device classification, the application process takes 6 to 9 months. Once approved, an Import Licenses (aka MD Form 15) is issued. From April 1, 2020 to October 1, 2021 India will implement a voluntary registration process with no government fee.
|Classification Type||Plant Master File||Device Master File|
|Class A Medical Device||US$1,000||US$50|
|Class B Medical Device||US$2,000||US$1,000|
|Class C Medical Device||US$3,000||US$1,500|
|Class D Medical Device||US$3,000||US$1,500|
Novel Medical Devices
Medical devices that are novel to the Indian market in terms of materials, mode of action, or intended use are considered ‘investigational devices’ and are subject to additional clinical investigation requirements and review, including establishing safety and effectiveness through clinical investigation in India.
A voluntary registration pathway is available to medical devices from April 1, 2020 to October 1, 2021. Medical devices submitted under the new voluntary rules are referred to as “Non Regulatory Medical Devices”. The registration process will generate a file number the same day which the importer must mention on the label of the medical device prior to placing the devices on the market.
After this voluntary period, all class A and B non-Regulatory medical devices will have 12 months (i.e., by October 1, 2022) to obtain an Import License. Class C and D devices will have 24 months (i.e., by October 1, 2023) to meet the same requirement.
Device Conformity Assessment
The registration process in India for imported devices is a re-assessment largely utilizing the same documentation and evidence required in the reference country review.
Devices registered during the voluntary registration period benefit from a truncated application that involves administrative documents such as Free Sales Certificate from the country of origin, ISO 13485 certificate, as well as basic product information. The voluntary registration process carries no government processing fees but may be cancelled or suspended by the CDSCO for product safety concerns, or when superseded by the requirement for the mandatory Import License.
Quality Systems Conformity Assessment
An ISO 13485 certification is required to certify the quality system/s of the legal and/or actual manufacturing facilities.
Exceptions to Home Country Approval Requirement
Home country approval is not required, applicants may instead submit reference country.
Australia – Canada – European Union – Japan – United States
Validity and Renewal
Import Licenses do not expire, so long as listing fees are paid every 5 years.
License Holder Requirements
The License Holding Agent is granted Power-of-Authority, listed on local labeling, and handles customs clearance, and post-market vigilance. Post-market vigilance entails notifying the CDSCO and Materiovigilance Programme of India (MvPi) of Serious Adverse Events (SAE) occurring in India.
No license transfers are available under the current rules.
Benefits of Independent License Holding through Asia Actual
- Sell directly to multiple regional distributors, avoiding mark-up by a national importer
- Increase transfer pricing
- Improve leverage in distributor negotiations/responses
- Add or change distributors as required
- Keep intellectual property away from local commercial agents
Contact Asia Actual for assistance with Medical Device Regulations in India.
List of Notified Medical Devices
- Disposable Hypodermic Syringes
- Disposable Hypodermic Needles
- Disposable Perfusion Sets
- IVD Devices for HIV, HBsAg, HCV
- Cardiac Stents
- Drug Eluting Stents
- Intra Ocular Lenses
- I.V. Cannulae
- Bone Cements
- Heart Valves
- Scalp Vein Set
- Orthopaedic Implants
- Internal Prosthetic Replacements
- Blood Grouping Sera
- Ligatures, Sutures and Staplers
- Intra Uterine Devices (CuT)
- Tubal Rings
- Surgical Dressings
- Umbilical tapes
- Blood/Blood Component Bags
- Ablation Devices
- Organ Preservation Solution
- Blood Pressure Monitors
- Digital Thermometers
- X-Ray Machines (Effective April 1, 2021)
- CT Scan Equipment (Effective April 1, 2021)
- MRI Equipment (Effective April 1, 2021)
- PET Equipment (Effective April 1, 2021)
- Defibrillators (Effective April 1, 2021)
- Dialysis Machines (Effective April 1, 2021)
- Bone Marrow Cell Separators (Effective April 1, 2021)
- All Implantable Medical Devices (Effective April 1, 2021)
- Ultrasound Devices (November 1, 2021)
- Disinfectants and insecticides specified in Medical Device Rules, 2017
*Seek guidance on application of categories
India Regulatory Support
Gunjan’s Regulatory Hint
“While the new medical device regulations are transitioning, it can be difficult to understand what requirements apply when. We can help.”
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Latest Market Updates
- India Postpones Registration Requirements for Certain Medical DevicesNovember 18, 2021 - 10:19 am
- India Temporarily Suspends Compulsory Medical Device RegistrationsOctober 5, 2021 - 12:51 pm
- India to Require All Medical Devices be Registered Before ImportationSeptember 23, 2021 - 10:02 am
- India’s Public Hospitals Advised to Purchase Local ProductsJune 15, 2021 - 3:26 pm
- India Announces New Notified Medical Devices Now Requiring Import LicensesJune 14, 2021 - 4:06 pm