Medical device registration in India and CDSCO route checks
Medical device registration in India starts with risk class and business activity. Check CDSCO routes, Class A exceptions and official device records.
Medical device registration in India starts with your device's risk class and whether you plan to manufacture, import or sell it. The application route depends on those checks, including any Class A nonsterile/nonmeasuring exemption or separate sale-premises requirements. CDSCO's device guidance and Medical Devices Rules index are the official starting points.
Don't treat "CDSCO registration" as one certificate for every device business. Use the dedicated MD Online portal to find the service and guidance for your activity.
Start with the device class and your activity
CDSCO identifies the Drugs and Cosmetics Act, 1940 and the Medical Devices Rules, 2017 as the regulatory framework. Its medical-device page lists four risk classes:
| Class | Risk level |
|---|---|
| A | Low |
| B | Low-moderate |
| C | Moderate-high |
| D | High |
Use these labels to orient your enquiry, not to assign a class from a product's name alone. The same CDSCO page points to Part I of the First Schedule for device classification. For an IVD enquiry, use the relevant IVD guidance rather than automatically applying that reference.
Write down your intended activity beside the device description. Use both when selecting a medical device licence service. Keep this application enquiry separate from a search for an existing device's approval record.
Check the specific Class A category
CDSCO lists a licensing exemption for Class A devices that are both nonsterile and nonmeasuring. Its Rules index identifies G.S.R. 777(E), dated 14 October 2022, as the relevant exemption notification. Do not extend this category to every Class A device or read it as freedom from all requirements.
Check the current requirements before relying on the exemption. The Gazette index lists an amendment dated 14 August 2026 whose title includes QMS requirements for Class A NSNM devices. Read the amendment itself for its conditions and start date. The index title alone is not a filing instruction.
Keep sale-premises registration separate
Selling devices raises a separate premises question. The Rules index lists G.S.R. 754(E), dated 30 September 2022, on registration of premises for medical-device sales. Check whether its requirements apply to your business instead of assuming a device-related record settles the premises issue.
Use the CDSCO medical device online portal
The dedicated MD Online portal identifies itself as the "Online System for Medical Devices". It offers application submission and tracking, industry guidance, MD/IVD FAQs, fees and checklists.
Start by finding the service that matches your activity and device category. Read its current checklist before preparing the submission. Check the fee resource for that service before paying, and use the portal's tracking facility after submission.
CDSCO's explanatory pages also contain older SUGAM references, and SUGAM remains accessible. If an instruction sends you there, confirm which service it concerns. Don't assume every central and state service has an identical workflow or that SUGAM has closed.
Check the official approved-device records
For an existing device, use the MD Online homepage to inspect the official records. It offers separate IVD and MD "Approved Device Details" options. The MD section includes "MD Manufacturer" and "Import" choices.
For import records:
- Open MD Online and choose MD "Approved Device Details".
- Select "Import" and use the Search field.
- Compare the importer name and address with the business you are checking.
- Match the licence number, device name, class and intended use.
- Check the brand and model, and note the issuing authority.
The import view has pagination, so inspect the relevant results rather than relying on the first visible row. Keep risk-classification information separate from a specific licence record: the portal also displays Class A NSNM classification and approved-device details.
A search hit does not settle current validity. The import table includes older records, including an entry issued in 2018. Confirm the licence's current status and exact scope before relying on it for a particular model. The record list alone does not establish that no later regulatory action exists. See the official lookup portal.
Confirm fees and timelines before filing
Use the current, service-specific fee resource and checklist on MD Online. Check the applicable processing provisions for the route you select. Don't plan a launch around a generic approval estimate or assume another applicant's fee applies to your device.
Before filing, confirm your classification and activity, any applicable Class A NSNM requirements, and the separate premises question. Then check the current service instructions. For an existing licence, match the exact device and model as well as the licence holder. Treat these as preparation checks, not a complete statutory submission list.
RegAffairs AI has a public answer on registering a medical device in India. Use official CDSCO sources for filing decisions. MD Online provides application guidance and approved-device records.