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Medical device registration or licence: documents, fees and how to apply online and offline

Under the Medical Devices Rules, 2017, class A and B device makers need a licence from the State, class C and D from CDSCO; importers need an import licence; new devices may need a clinical investigation.

Issued byCentral Drugs Standard Control Organisation and State Licensing Authority
Government feeAs set in the Medical Devices Rules, 2017 for each class, site and product
Usual time1 to 6 months
ValidityValid while retention fees are paid
Apply on the official portalApplying is free of agents; pay only the government fee shown on the portal.
Open the portal

How to apply online, step by step

  1. Classify the device by risk (A to D) using CDSCO's classification lists.
  2. Set up a quality management system (ISO 13485).
  3. Apply on the CDSCO online portal (SUGAM / National Single Window) in the form for your class and activity.
  4. Inspection and grant of the licence.

How to apply offline (in person)

  1. No paper route; CDSCO zonal offices help.

Documents required for Medical device registration or licence, and how to get each

Constitution documents: incorporation certificate, MoA and AoA (company), LLP agreement, or partnership deed

Get it online

  1. Company: the Certificate of Incorporation, e-MoA and e-AoA come with SPICe+ on the MCA portal.
  2. LLP: the LLP agreement is filed in Form 3 on the MCA portal within 30 days of incorporation.

Get it in person

  1. Partnership: print the deed on stamp paper of the value the State prescribes, sign before witnesses, notarise, and register it with the State Registrar of Firms.

Fee: Stamp duty as per the State · Time: With incorporation · Official site

Site plan, layout of machines and process flow chart

Get it online

  1. Prepare a simple layout drawing (an architect or engineer can certify it if the authority asks) and a step-by-step process chart.

Get it in person

  1. Same, printed and signed.

Fee: Professional fee if certified · Time: 1 to 3 days

Product test report from a BIS-recognised or NABL-accredited laboratory

Get it online

  1. Find a recognised lab for your product standard on the BIS portal and send samples.

Get it in person

  1. Deliver the samples to the lab with the product specification.

Fee: Set by the laboratory · Time: 1 to 6 weeks · Official site

Qualification certificate required for the trade (for example agriculture degree or diploma, pharmacist registration)

Get it online

  1. Download the State council or university certificate, or the course completion certificate, from its portal.

Get it in person

  1. Collect a certified copy from the issuing institution or council.

Fee: As set by the issuer · Time: Varies

Questions people ask

How much does Medical device registration or licence cost?

As set in the Medical Devices Rules, 2017 for each class, site and product

How long does Medical device registration or licence take?

1 to 6 months

Who issues Medical device registration or licence?

Central Drugs Standard Control Organisation and State Licensing Authority

Can I apply for Medical device registration or licence without an agent?

Yes. Every step above can be done by the founder on the official portal or at the office; agents and consultants are optional.

Official source: https://cdsco.gov.in/. Rules and fees change; the official page is the authority. Checked October 2026.

Find out everything your startup needs

The Startup Evaluator lists the registrations and licences for your sector, State and team size, in the order to get them, with costs, schemes and a three-year cash plan. All licence guides.