Regulations
Fact-checked by Morulaa Health Tech, Regulatory Consultant with 15+ years of CDSCO experience.
To enter the Indian market, overseas manufacturers must appoint an Authorized Agent. Morulaa as a leading CDSCO license consultant, provides a turnkey solution for CDSCO registration of Medical Devices, which under Indian Medical Device Rules (MDR 2017) includes Medical devices, In Vitro Diagnostics (IVDs) and Software as a Medical Device (SaMD).
Our regulatory experts streamline your market access by:
Determining Classification & Grouping: We guide you through critical CDSCO medical device classification (Classes A, B, C, and D) and optimize device grouping to significantly reduce government fees.
Handling Technical Documentation: Our team manages the "heavy lifting," from compiling Technical Dossiers and Plant Master Files to conducting Substantial Predicate Analysis.
Securing Import Licenses: We take care of everything to get your medical device import license from CDSCO, which is also known as Form MD-15 on the SUGAM portal. This usually takes around six to nine months for products that have been notified.
Compliance: After we get the initial approval we keep track of what happens to the products after they are in the market. We also take care of reporting any events and renewing licenses so that your medical devices keep following the rules.
Our regulatory expertise covers the full spectrum of products regulated under the MDR 2017, including:.
Medical Devices (MD)
In-Vitro Diagnostics
(IVD)
Software as a Medical Device (SaMD)
Appointing an Independent Authorized Indian Agent versus a commercial distributor is a foundational strategic decision for the Indian market. While a distributor focuses on sales and stocking, an independent CDSCO license consultant acting as your IAA decouples your regulatory assets from your commercial partnerships. This structure ensures your CDSCO medical device import license remains neutral and provides the following professional advantages:
CDSCO registration for medical devices requires sharing sensitive device and manufacturing data. As your CDSCO license consultant, we keep this proprietary information from a commercial partner, protecting your IP while meeting CDSCO medical device regulation
A distributor-held license limits you to one importer. An independent Indian Authorized Agent lets you appoint multiple distributors across India, saves you redundant fees, maintenance of multiple licenses, and ensures your supply chain isn't tied to a single partner.
The medical device rules CDSCO demands focused oversight on renewals and Post-Market Surveillance and staying updated with the constantly changing regulatory environment. We handle the compliance so your CDSCO medical device import license stays valid without commercial distractions.
Case Study - In 2025, our team assisted a Class C ventilator manufacturer in transitioning from a distributor-held license to an independent license in 38 days, maintaining an uninterrupted device flow and securing the supply chain against a potential 3-month blackout.
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
Under the medical device rules CDSCO (2017), products are classified into four risk-based categories. This CDSCO medical device classification determines your specific regulatory pathway:
Class A (Low Risk) includes medical tools like absorbent cotton wool, wheelchairs, lab cleaning solutions and general test media.
Class B (Low to Moderate Risk) covers devices that have limited contact with the body or have an impact, such as the following: Digital thermometers, blood pressure monitors, pregnancy test kits, vitamin B12 tests
Class C (Moderate to High Risk) involves complex or invasive products, including the following: Ventilators, bone cements, software for checking retinopathy, glucometers for blood sugar tests, and cancer biomarker tests
Class D (High Risk): Critical care and life-sustaining products, including Heart Valves, Coronary Stents, HIV Diagnostic Kit and Blood grouping reagent.
The classification of a device in India is usually aligned with the EU MRD classification. As a specialized CDSCO license consultant, Morulaa helps determine the classification of your products along with preparing the rationale for it to confirm the correct regulatory pathway and secure your CDSCO medical device import license.
As of November 27, 2025, the CDSCO has enabled a dedicated Risk Classification Module on the SUGAM portal, allowing manufacturers to obtain official guidance on the risk class for devices whose intended uses have not yet been published.
The Central Drugs Standard Control Organisation, which is part of the Ministry of Health and Family Welfare is the group that oversees the Central Drugs Standard Control Organisation medical device rules, in India.The Central Drugs Standard Control Organisation makes sure that all medical devices and healthcare products are of good quality following the rules that are set by the Medical Device Rules, 2017 and the Drugs and Cosmetics Act, 1940.The Central Drugs Standard Control Organisation does this to protect people in India. A comprehensive knowledge of the medical device rules CDSCO is a mandatory requirement before initiating market entry. A foreign manufacturer must select a local Indian authorized agent who manages your CDSCO registration for medical devices by acting as a point of contact for submission, assisting in device approvals, handling license holding, managing vigilance and post-market compliances.
This authorized agent will apply for an Import License by submitting Form MD-14 to CDSCO, which grants the Import License through Form MD-15 upon successful evaluation.
Your authorized agent first uploads the technical dossier via Form MD-14 on the SUGAM portal to initiate the CDSCO registration for medical devices. We then manage the "Query & Response" phase to resolve any technical clarifications regarding your CDSCO medical device classification. Once the regulators are satisfied, you receive the official Form MD-15 approval, granting your CDSCO medical device import license and allowing you to legally import and market your products in India.
RA Pro-Tip - The "Dossier Assessment" phase is where most delays happen due to minor clerical mismatches between the label and the FSC and sometimes even legalization. By performing a pre-submission audit, we often cut down the clarification cycle by 2-3 months, keeping your timeline on track.
Important Regulatory Update: As of October 2023, CDSCO registration for medical devices classes (A, B, C, and D) have moved under the mandatory registration scheme. Without a valid registration number, no product can be legally exported into India. Our first step is to determine your product’s specific regulatory pathway: either the "Self-Notified" route for low-risk devices (like Class A non-sterile/non-measuring, which offers a 1-day automatic registration), or the standard "Notified" process which requires CDSCO’s review of your documentation and subsequent approval.
For overseas RA teams managing simultaneous EU-MDR transitions and global registrations, the Indian regulatory process can often feel repetitive. Morulaa eliminates this redundancy by taking full ownership of the technical file preparation, allowing your team to focus on core compliance.
We act as your proactive in-house consultant rather than a passive reviewer. By utilizing your existing MDD, MDR, US-FDA or your home country technical documentation, we directly map your data directly to the medical device rules CDSCO requirements. Our team handles the heavy lifting of document creation, ensuring that the application is ready for the SUGAM portal within 48 to 72 hours of receiving your technical file.
Our technical team extracts and performs the following for you,:
Drafting the Power of Attorney and MD-14 Legal Forms which will act as the final approval certificate.
Converting your Annex II (MDR) documentation directly into the Device Master File format.
Preparing the CDSCO medical device classification rationales and Grouping Justifications.
Identifying and execution of the substantial predicate device analysis of a similar device available in India.
Drafting of executive summaries for Biocompatibility, Design Verification & Validation (V&V), Risk Management, Clinical Evaluation Reports (CER) and other tech files.
As your CDSCO license consultant, we don't wait for you to confirm every detail. This streamlined approach allows you to secure your CDSCO medical device import license with minimal administrative burden on your internal team.
A predicate device is one previously approved for manufacture or import in India, sharing a similar intended use, material, and design. However, if your technology is a "New Medical Device" with no existing predicate, it falls under Rule 63 of the Medical Device Rules (2017).
As your CDSCO license consultant, we manage this complex pathway by preparing the Form MD-26 application for the Central Licensing Authority. Under this rule, the following technical conditions apply:
If no predicate exists, you must secure permission in Form MD-27. A Special Expert Committee (SEC) typically reviews the technical data to recommend marketing approval or additional clinical trials (Form MD-23).
Clinical investigation results may be waived if the device is already approved and marketed for at least two years in the USA, UK, Australia, Canada, or Japan, provided the Central Licensing Authority is satisfied with the safety and performance data.
Once Form MD-27 is granted, the permission holder must submit a Periodic Safety Update Report (PSUR) every six months for the first two years, and annually for the following two years. Any suspected unexpected serious adverse events must be reported within 15 days.
By leveraging our expertise in CDSCO medical device classification, we determine if your product qualifies for these clinical data relaxations, ensuring a faster route to your CDSCO medical device import license.
The time-to-market for your device in India is directly influenced by its global regulatory standing and the presence of similar products in the local market. By mapping your CDSCO medical device classification against the criteria below, we identify the most streamlined route for your CDSCO registration for medical devices.
As your CDSCO license consultant we handle everything through our portal. Here are the fees for CDSCO registration for devices
Important Timeline Refinement: Keep in mind that timelines can shift. While these are defined timeframes, the countdown "stops the clock" the moment the regulator raises a technical query.
Validity
A license remains valid indefinitely. To maintain its validity, the manufacturer must pay the license retention fee every five years. The CDSCO allows late payment within ninety days of the due date, subject to a late fee of 2% per month. Failure to pay the retention fee within this extended period will result in the automatic cancellation of the license.
Renewal
The import license issued under the CDSCO medical device regulation needs to be renewed every 5 years and should be renewed within 6 months prior to expiry. For a smooth renewal, manufacturers must inform CDSCO of any changes in the device during its commercial life. The following are the base documents required,
Updated regulatory certificates
Changes made on the device over the last 5 years
Changes made in the site over the last 5 years
Post market data for India
Undertakings for no change in constitution
Post market change approval certificates
The manufacturer can begin exporting to India after permission. Take into account the following factors:
Upon approval, the manufacturer can start exporting to India. Keep the following considerations in mind:
The manufacturer can only invoice the Indian agent under whose name the registration was obtained.
All shipping documents (Invoice, Packing List, BOE and Batch Release Certificate) accompanying each consignment must be verified prior to the dispatch from the manufacturer's location for local compliance and smooth customs clearance.
Invoice must contain the device model number and name exactly as per the import license obtained
The product shipped to India must have a minimal 60% residual shelf life
HSN code must be uniform with the invoice and clearly state any demo item
How can I find out if my IVD or medical device is subject to Indian regulations?
To determine your regulatory pathway, we cross-reference your product against the official risk classification lists published by the CDSCO. We also analyze currently approved devices to identify a substantial predicate device in the Indian market, which can often streamline your clinical data requirements and shorten the approval timeline.
Can foreign manufacturers manage their own CDSCO SUGAM login?
No. Overseas manufacturers cannot directly create a login on the SUGAM portal. You must appoint an Indian Authorized Agent who possesses valid local wholesale licenses to manage your profile and submit your Form MD-14 application.
Besides the CDSCO MD-15 Import License, what other certifications are needed for the Indian market?
BIS Certification if the product has a battery associated with the shipment Plastic Waste Management and declarations Electronic Waste disposal Price Control Policy wherein the price of the importer, price to distributor and Maximum Retail Price (MRP) is submitted on a Government portal Legal Metrology
Can a CDSCO registration be transferred if I set up my own branch in India?
A transfer is not possible and the manufacturer would need to re-register again. The Indian subsidiary in this case would be the license holder and legally responsible for all imports into India.
Does my device require local clinical trials in India?
Most devices with a substantial predicate or a two-year marketing history in a GHTF country (USA, UK, Australia, Canada, or Japan) can bypass local clinical trials via a clinical data waiver. However, "New Medical Devices" with no predicate (Rule 63) may require a Special Expert Committee (SEC) review and potential local clinical investigation.
Can I register multiple product variants under a single CDSCO application?
Yes. By utilizing Family or System Grouping, you can bundle similar devices that share the same manufacturer, risk class, and intended use into one application. This strategy is the most effective way to reduce government fees and simplify license maintenance.
What is the typical timeline for securing a CDSCO Import License?
For "Notified" medical devices and IVDs, the standard evaluation cycle typically takes 6 to 9 months. Low-risk Class A non-sterile devices can often secure automatic registration via the self-notification route in as little as one day.
How does using an Independent Agent protect my Intellectual Property (IP)?
Appointing an independent CDSCO license consultant as your agent ensures your sensitive manufacturing data and Technical Dossiers are not shared with commercial distributors. This keeps your regulatory assets neutral and prevents "distributor lock-in," allowing you to change or add sales partners without losing your market access.
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