Hospital and clinic licensing, Karnataka
All the licences, registrations and accreditations your healthcare facility needs, in one place, with one team to get them done.
- KPME and NABH
- Drug, fire, KSPCB, biomedical waste
- PC&PNDT, AERB, trade, FSSAI
Opening a clinic, lab, nursing home or hospital in Karnataka needs approvals from several departments. Start with KPME registration, add the licences your building, services and equipment require, and consider NABH accreditation for quality, insurance empanelment and faster KPME. Choose a licence below.
Choose a licence
KPME registrationThe core licence for every private clinic, lab and hospital in Karnataka. 18 categories, fees, documents, renewal.
NABH accreditationHospital, SHCO, Entry Level, clinic and dental programmes. 6th edition standards and official fees.
Drug licenceForm 20 / 21 pharmacy licence from Karnataka Drugs Control. Rs 1,500 each, 10 sq m minimum.CDSCO medical device licencesMedical device import, manufacturing and MD-42 sale registration under the Medical Devices Rules, 2017.Fire NOCFire clearance from Karnataka Fire and Emergency Services, required for high-rise buildings above 15 m.
KSPCB consentConsent for establishment and operation for bedded hospitals, through the XGN portal.Biomedical wasteAuthorisation under the BMW Rules 2016 and a common treatment facility agreement for every facility.
PC&PNDTRegistration for ultrasound and genetic services. Rs 25,000 / 35,000, valid 5 years.MTP approvalPlace approval for medical termination of pregnancy under the MTP Act.
AERB licenceX-ray, CT, C-arm and dental X-ray registration through eLORA.Trade licenceHealth trade licence from the city corporation or local body, renewed yearly.
Shop and establishmentRegistration under the Karnataka Shops and Commercial Establishments Act for staff.
FSSAI food licenceFor hospital kitchens, diet services and canteens, through FoSCoS.Which licences does my facility need?
| Licence | Clinic | Dental | Lab | Imaging | Hospital |
|---|---|---|---|---|---|
| KPME registration | Yes | Yes | Yes | Yes | Yes |
| Biomedical waste authorisation | Yes | Yes | Yes | Yes | Yes |
| Trade licence (local body) | Yes | Yes | Yes | Yes | Yes |
| Shop and establishment | Usually | Usually | Usually | Usually | Usually |
| Drug licence | If pharmacy | If pharmacy | No | No | Yes (pharmacy) |
| KSPCB consent (CFE / CFO) | No* | No* | No* | No* | Yes (bedded) |
| Fire NOC | By building | By building | By building | By building | Usually |
| AERB | If X-ray | If RVG / OPG | No | Yes | If X-ray / CT |
| PC&PNDT | If ultrasound | No | No | If ultrasound | If ultrasound |
| MTP approval | If MTP done | No | No | No | If MTP done |
| FSSAI | No | No | No | No | If kitchen / canteen |
| CDSCO / medical device licence | Only if you import, manufacture, sell or distribute medical devices | ||||
* Non-bedded facilities: KSPCB's August 2026 circular says they continue with one-time biomedical waste authorisation. Your exact list depends on your building, services and equipment; ask us for a free check.
Full details on each licence: hospital and clinic licences in Karnataka.
Typical order for a new facility
- Premises and plans: building approvals, layout for clinical areas, fire design for larger buildings.
- Environment: KSPCB consent for bedded hospitals and biomedical waste authorisation.
- Equipment approvals: AERB for X-ray, PC&PNDT for ultrasound, before first use.
- Pharmacy: drug licence with a registered pharmacist.
- KPME registration: provisional certificate, inspection and permanent registration.
- Local and labour: trade licence, shop and establishment, FSSAI for kitchens.
- Quality: NABH Entry Level or accreditation once systems are running.
Planning a new hospital? Our complete hospital set-up service covers design, licences and equipment.
Get a free licence check for your facility
Tell us your facility type and city. We will tell you which KPME category applies, what documents you need and what else your facility must have (fire, pollution, drug licence and so on).
Frequently asked questions
What licences are needed to start a hospital in Karnataka?
What licences does a clinic need in Karnataka?
What is KPME registration?
Is NABH accreditation mandatory?
Which licences need renewal?
Can Medasus handle all licences together?
One team for all your licences
Talk to the Medasus licensing team in Bengaluru. We handle the portal filing, documents and inspection preparation.
Last reviewed on 2 November 2026 against: KPME portal; NABH; Karnataka Drugs Control Department; KSPCB XGN. Medasus Healthcare Pvt Ltd is a private consultancy that helps establishments prepare and file applications. Licences and approvals are granted only by the respective government departments; Medasus cannot guarantee approval or timelines. Rules and fees change, so always check the official source before applying.
