Regulations
Fact checked by Morulaa Health Tech, Regulatory Consultant with 15+ years of CDSCO experience
Last Updated: 06 August 2026
Determining the Classification & Group: We know the subtleties of CDSCO requirements inside out, allowing us to advise you which group your product falls under in order to make registering more cost effective as certain categories are subject to lower registration fees.
Navigating the Technical Documentation: From finding a predicate device to dossier submission, we have the expertise and know how to handle the process end to end
Securing medical device license India : We take care of securing your medical device’s entry into the Indian market and registering it with CDSCO (Indian FDA). The process takes 6-9 months for notified devices as of the notification date. We also assist in obtaining the Import License from CDSCO also known as the Form MD-15 application on the SUGAM portal.
Compliance: We also ensure that medical devices comply with all applicable regulations as well as register complaints, report adverse events, and renew medical device registrations in India to maintain a consistent supply of your medical devices in the country.
As a full service India medical device registration consultancy, we offer registration for all healthcare products covered by the MDR 2017, including:
Medical Devices (MD)
In Vitro Diagnostics (IVD)
Software as a Medical Device (SaMD)
Deciding to appoint an Indian Authorized Indian Agent (IAA) or authorizing a distributor is a choice to be made right at the beginning of entering the Indian market. Commercial distributors focus solely on sales, stocking, and logistics of medical devices, while Indian Authorized Agent takes care of regulatory compliance and holds the regulatory license. By separating regulatory assets from commercial partnerships, foreign manufacturers secure the ability to work with different distributors and maintain exclusive control over the medical device license in India.
A distributor held license restricts you to one exclusive importer, while an independent Indian Agent opens the possibility to work with several distributors in India and avoid extra costs and responsibilities associated with maintaining multiple licenses.
India medical device regulations are continuously evolving, and CDSCO oversees the control and supervision of medical devices on the Indian market, including Post Market Surveillance and license revalidation. We take on the responsibility for your CDSCO medical device import license and associated compliance, so you can focus on your commercial goals in India.
CASE STUDY : In 2025, our team successfully transitioned one Class C Ventilator manufacturer from the Distributor held licensing model to an Independent licensing model, completing all necessary procedures within 38 days and avoiding potential supply chain disruptions worth 3 months of continuous device supply.
The regulatory pathway for importing a medical device is determined based on risk classification, availability of a predicate device in India, and whether the device has approval from a GHTF country.
Risk Classification of Medical Devices
As per the Medical Device Rules (MDR) 2017, the Central Drugs Standard Control Organization (CDSCO) has classified medical devices in four different risk based categories. This division depends upon the application of medical devices, and based on this, the type of regulatory pathways, application forms fees, timelines for the Import License under CDSCO are decided. Medical devices range from low risk (Class A) to high risk (Class D). The class of a medical device decides the amount of technical dossier documentation needed for regulatory approval by the concerned authority.
Classification of Medical Devices as per MDR 2017 & Its Regulatory Requirements
The four classes of medical devices under MDR 2017 are:
Class A (Low Risk): Absorbent cotton wool, Wheelchairs, Lab cleaning solution, and lab test media.
Class B (Low to Moderate Risk): Devices with minimal or no invasive interaction include Digital thermometers, Sphygmomanometer, Pregnancy test kits, Vitamin B12 test.
Class C (Moderate to High Risk): Moderate to High risk medical devices include Ventilators, Bone cement, Software for screening of retinopathy, Glucometer for sugar testing, Cancer screening tests
Class D (High Risk): Life supporting and life saving medical devices include Heart Valves, Coronary Stents, HIV Diagnostic Kit, Blood grouping reagent.
India Medical Device Regulations and Classification are aligned with the EU MDR Classification. Morulaa, as a renowned CDSCO license consultant, helps the applicant identify their products’ classifications and prepare justification documents for Regulatory Affairs submissions for medical device import licensing in India.
From November 27, 2025, CDSCO has activated the Risk Classification Module on the SUGAM portal for defining risk classifications for medical devices with novel or innovative intended use not listed in the portal. With the expertise of Morulaa as your medical device regulatory consultant company in India, you can identify the risk classification for your medical device.
To obtain an Import License for medical devices in India, the Indian Authorized Agent has to submit the Form MD-14 plus the technical dossier through the online portal CDSCO SUGAM, which in turn will start the regulatory assessment process. During this step, the Indian agent has to deal with any clarifications or additional information requests from the competent authority. Finally, upon positive evaluation and after fulfilling the regulatory requirements, the CDSCO will issue the medical device import license in the Form MD-15 to the concerned Indian Authorized Agent. Therefore, as your legal Indian Authorized Agent, we can take full responsibility for the end to end processing of your MD-14 to MD-15 to ensure the legality of your device import into India.
RA Pro Tip →
The “Dossier Assessment” is where usually the biggest hurdle is created due to some minor clerical mismatch with either the label or the FSC or even legalization. So, with our pre submission audit, we usually bring down your clarification cycle to 2-3 months as compared to a standard 6 months or more.
Important Regulatory Update: As of October 2023, all medical devices are subjected to India medical device registration. So, without a valid registration number, you cannot clear customs in India. Our first step would be to identify the right regulatory pathway applicable to your product, which could either be the “Self Notified” route for lower risk devices (Class A Non Sterile/Non Measuring which can be registered in 1 day on an automatic approval basis) or the standard “Notified” procedure, which will involve the regulatory assessment of your submitted technical dossier by CDSCO followed by their approval.
For overseas RA teams handling parallel EU MDR transition and global registrations, Indian regulatory process can seem to be quite tiresome. We take up the role of an in house consultant rather than a reviewer. With your existing MDD, MDR, US FDA or your home country technical documentation, we directly tie in your data with medical device rules CDSCO requirements. Our process allows us to get your application ready for the SUGAM portal within 48-72 hours of receipt of your technical file.
The technical team works on extracting the below from your given technical documentation:
Drafting of Power of Attorney and MD-14 Legal Forms which will be your approval letter.
Conversion of your Annex II (MDR) documentation into Device Master File format
Preparation of CDSCO medical device classification rationales and Grouping justification
Identification and execution of substantial predicate device analysis of similar device in India
Drafting of executive summaries for Biocompatibility, DVT&V, RISK MANAGEMENT, CER and other tech files
As your CDSCO license consultant we do not keep you waiting for the approvals as this reduces the lead time for your CDSCO medical device import license.
A predicate device is a medical device that has been legally marketed in India and is substantially equivalent to the device that is being registered. A "new medical device" is any device not having a predicate device. According to the Regulation 63 of Medical Devices Rules, in such cases, applications for registration of new devices shall be made to the Central Licensing Authority.
As your CDSCO registration consultant, we prepare Form MD-26 application to the Central Licensing Authority. As per Rule 63 for new medical devices with no predicate, below are the technical conditions:
The applicant shall get permission in Form MD-27
The technical data shall be evaluated by the Special Expert Committee for their opinion on marketing the said device or to conduct clinical investigation in India of the concerned device in Form MD-23.
The clinical investigation of a device may be waived if it has been legally marketed in the USA, UK, Australia, Canada or Japan for a period of 2 years, if the Central Licensing Authority is satisfied with the relevant data regarding the safety and performance of the device.
Once the permission has been granted in Form MD-27, the person permitted shall send in the PSUR on a yearly basis for the first two years and then once every year for the subsequent two years. In addition to that, any SUSAR shall be reported within 15 days.
With our CDSCO medical device classification expertise (Analyze the classification logic for Software As Medical Device, Class A (Self Notified) and Ophthalmology), we can help you assess if your device qualifies for any of the relaxations for clinical data mentioned above; thus helping us get you to your CDSCO medical device import license faster.
The time to register your device in India will be governed by the device's international footprint as well as similar devices available in the Indian market. By analyzing your medical device against the below requirements we can determine the fastest possible route to registration.
As your CDSCO license consultant we handle everything through our portal. Here are the fees for CDSCO registration for devices
Important Timeline Clarification: While these are generally time frames, please note that the regulator can always "stop the clock" on timelines if they raise any technical questions
Validity
A license is valid forever provided that the license retention fees are paid every 5 years. CDSCO allows a 3 month grace period on the license retention fee with a penalty of 2% per month. The license will be canceled if the fee is not paid after the 3 month's grace period.
Renewal
A CDSCO medical device import license needs to be renewed every 5 years and must be renewed 6 months before the expiry date. The manufacturer must ensure that CDSCO is informed about any changes in the device design over the period of the license. The following documents are required for renewal of the CDSCO license:
Updated regulatory certificates
Any changes in the device during the period of validity of the license
Any changes in the site during the period of validity of the license
Post market data for India
Undertaking of no change in the constitution
Post market change approval certificates
After getting the license approved, the manufacturer can start exporting to India with the below considerations:
The manufacturer can invoice only the Indian Agent under whom the application was originally made.
All shipping documents (Invoice Packing List, BOE and Batch Release Certificate) pertaining to each consignment must be cleared by the manufacturer prior to despatch from the manufacturer's site for local compliance and customs clearance
The invoice must carry the device model number and/or name exactly as it appears in the import license obtained from CDSCO
The product sent to India should have minimum 60% shelf life remaining
The HSN code must match across invoice and indicate any demo item, if any
How can I find out if my IVD or medical device is subject to India Medical Device Regulations?
To determine this, refer to CDSCO's risk classification lists to check if the category of your medical device or IVD falls under their regulatory scope. In addition, it is important to determine if there is already an approved equivalent of your device, as finding a substantial predicate device can drastically reduce your submission burden and regulatory review time.
Can foreign manufacturers manage their own CDSCO SUGAM login?
No. Foreign manufacturers are not permitted to apply on their own. The foreign manufacturer must appoint an Indian Agent who has a valid wholesale license to do the following for them Login to the SUGAM portal to apply for their Form MD-14 application
Besides the CDSCO MD-15 Import License, what other certifications are needed for the Indian market?
BIS Certification if battery is present with the goods, Plastic Waste Management and declaration, Electronic Waste disposal Price Control Policy wherein the price of the importer, price to distributor and Maximum Retail Price (MRP) is declared on a government portal, Legal Metrology
Can the India medical device registration be transferred if I set up my own branch in India?
The India authorization cannot be transferred and the manufacturer would need to apply afresh. The local subsidiary in this scenario would be the legal entity and hence, the applicant in India for all licensing purposes. However, the parent company could continue to hold the ownership stake in the local entity.
Does the medical device license India require local clinical trials?
Most devices with substantial predicate or 2 years of marketing in GHTF countries (i.e., USA, UK, Australia, Canada, or Japan) can bypass local clinical trials. However, New Medical Devices with no predicates (Rule 63) may need clinical trials and/or SEC review.
Can I register my multiple product variants in India using one application?
Yes, using family or system grouping, manufacturers can group devices together with similar functions, same manufacturer and same risk class. This is the most effective way to defer government fees and reduce the overall licensing maintenance cost.
What is the time frame for obtaining a CDSCO medical device Import License?
For "Notified" medical devices and IVDs, the standard review process takes between 6 to 9 months. Class A non sterile devices typically get automatically approved through the self declaration route in just a few days.
How does using my medical device regulatory consultants in India as my authorized agent (IAA) protect my Intellectual Property (IP)?
By using an independent licensing consultant as your agent, your critical manufacturing data, and technical dossier know how will remain protected as they are not shared with commercial distributors. This ensures that your regulatory assets are kept neutral, and you can switch between different distribution channels easily without being tied to one distributor ("locked in").
Latest Market Updates
CDSCO Medical Device Labeling Requirements & Standards
Indian Authorized Agent (IAA) for Medical Device Import
CDSCO Medical Device Registration Disposal Rejection Of Long Pending Applications on SUGAM Portal Awaiting Query Response
Ministry of Health and Family Welfare: Medical Devices Rules 2017 Draft Amendments (G.S.R. 515(E)) June 2026
How to Prepare a Medical Device Dossier for CDSCO Registration
Free Sales Certificate (FSC) for Medical Devices in India
