Starting a diagnostic centre in Delhi requires careful planning, the right premises, qualified medical professionals and compliance with the registrations applicable to the services you intend to provide.
The requirements can differ depending on whether you plan to operate a pathology laboratory, X-ray centre, CT scan centre, ultrasound centre, MRI centre or a multi-service diagnostic facility. Therefore, it is important to identify the applicable registrations before starting operations or investing in specialised equipment.
At Remind Legal LLP, we assist businesses with registrations, documentation and regulatory compliance required for setting up a diagnostic centre in Delhi.
Planning to start a diagnostic centre in Delhi? Get professional assistance with the applicable registrations and compliance requirements.
A diagnostic centre handles patient information, medical samples and diagnostic equipment. Some facilities may also use equipment involving ionising radiation or provide services regulated under specific healthcare laws.
Following the applicable compliance requirements can help the centre operate legally, maintain appropriate safety standards and establish credibility with patients, doctors and healthcare institutions.
The requirements are service-specific. For example, applicable X-ray and CT equipment falls under the AERB's regulatory framework, while the ultrasound facilities covered by the PC-PNDT Act have separate or distinct registration and record-keeping requirements.
Similarly, diagnostic centres and pathology laboratories generating biomedical waste need to comply with the applicable biomedical-waste requirements.
Therefore, the best approach is to identify the registrations applicable to your specific diagnostic services, premises and equipment, rather than treating every healthcare approval as mandatory for every centre.
Step 1: Choose the Right Business Structure
The first step is to choose a suitable legal structure for your diagnostic centre.
Depending on ownership, investment, liability and expansion plans, you may consider: -
A suitable and appropriate structure can help establish clear ownership and make future expansion and financial management easier.
Step 2: Obtain PAN & TAN, Where Applicable
A Permanent Account Number (PAN) is required for the business or proprietor, as applicable, for taxation and financial transactions.
TAN (Tax Deduction and Collection Account Number) is required where the business has an obligation to deduct or collect tax at source under applicable provisions.
TAN is therefore a where-applicable requirement and is not a separate healthcare licence.
Step 3: Open a Current Bank Account
A dedicated current bank account should be opened in the name of the business.
It can be used for: -
Step 4: GST Registration, Where Applicable
GST Registration should be obtained where required under the applicable GST provisions. The applicability depends on the nature and type of services, taxable supplies, turnover and various other relevant factors. A diagnostic centre should therefore assess its specific activities rather than assuming that GST registration is automatically mandatory or unnecessary.
Step 5: Ensure Qualified Doctors & Technical Staff
A diagnostic centre should have appropriately qualified professionals for the services it offers.
Depending on the nature of the centre, this may include: -
Professional qualifications and registrations should be maintained as applicable to the services being provided.
For ultrasound facilities covered by the PC-PNDT framework, the registration process also requires relevant information regarding doctors, their qualifications and professional registration.
Step 6: Premises, Municipal Compliance & Health Trade Licence
The premises should be suitable for the proposed diagnostic activities and comply with applicable building, land-use and municipal requirements.
Before finalising the premises, consider: -
Health Trade Licence
A diagnostic centre may require the applicable Health Trade Licence/Diagnostic Centre Permit under the relevant municipal health-trade framework. MCD's current Unified Health Trade Licensing Portal specifically lists Diagnostic Centre Permits and Pathology Lab Registration under the medical establishments. The applicable licence should be assessed and obtained before commencing the operations
Step 7: Shops & Establishment Registration, Where Applicable
The diagnostic centre should comply with applicable Shops & Establishment requirements governing commercial establishments and employees.
Depending on the establishment and applicable rules, this may cover areas such as: -
The exact applicability should be assessed according to the nature of the centre and its workforce.
Step 8: Biomedical Waste Management Authorisation, Where Applicable
Diagnostic centres and pathology laboratories may generate biomedical waste such as used needles, contaminated materials, laboratory waste and other healthcare-related waste.
Where applicable, the centre should obtain the required Biomedical Waste Management Authorisation and maintain appropriate arrangements for segregation, storage, collection and disposal.
This is an important compliance area for diagnostic facilities that generate biomedical waste.
Step 9: DPCC Compliance, Where Applicable
Depending on the activities of the diagnostic centre, applicable Delhi Pollution Control Committee (DPCC) consent and/or authorisation requirements may apply.
DPCC-related compliance should be assessed according to the nature of the diagnostic services, waste generated and other applicable environmental requirements.
For a centre generating biomedical waste, the relevant biomedical-waste compliance should also be addressed.
Step 10: AERB Approval/Licence for Applicable Equipment
If the diagnostic centre uses equipment such as: -
the applicable Atomic Energy Regulatory Board (AERB) requirements must be completed.
AERB's regulatory framework covers medical diagnostic X-ray equipment and uses the e-LORA system for applicable regulatory processes.
Compliance may involve requirements relating to: -
RSO, Where Applicable
Where required under the AERB framework, the centre should have an appropriately qualified Radiological Safety Officer (RSO).
MRI Clarification
MRI does not use ionising X-ray radiation, so it should not automatically be treated as requiring the same AERB X-ray licensing applicable to X-ray and CT equipment.
Step 11: PC-PNDT Registration for Applicable Ultrasound Services
If the diagnostic centre provides ultrasound services or other procedures covered by the Pre-Conception and Pre-Natal Diagnostic Techniques (PC-PNDT) Act, the applicable registration must be obtained.
The registration process involves details relating to: -
Form F Compliance
PC-PNDT compliance does not end with obtaining registration. Where applicable, the centre must also maintain prescribed records, including Form F and follow the applicable ongoing record-keeping requirements.
Step 12: Fire Safety NOC, Where Applicable
Depending on the building, height, occupancy, premises and applicable fire-safety requirements, a Fire Safety NOC/Certificate may be required.
Fire-safety requirements should ideally be assessed while finalising the premises so that necessary arrangements can be made before the centre begins operations.
Step 13: Nursing Home Registration, Where Applicable
Nursing Home Registration is not a universal requirement for every diagnostic centre.
It should be assessed only where the facility also operates as a qualifying private hospital or nursing home with applicable inpatient facilities.
A standalone pathology laboratory or diagnostic centre should not automatically be treated as a nursing home merely because it provides medical diagnostic services.
Step 14: Labour, EPF & ESI Compliance, Where Applicable
If the diagnostic centre employs doctors, technicians, reception staff, phlebotomists, housekeeping staff or other employees, applicable labour and employment requirements should be followed.
Depending on employee strength and statutory applicability, this may include: -
The exact and accurate applicability depends on the workforce and the relevant statutory thresholds.
Step 15: Udyam Registration – Optional
An eligible diagnostic centre can consider obtaining the Udyam Registration under the MSME framework.
Udyam Registration is not a substitute for the healthcare-specific approvals, but eligible businesses may benefit from the applicable MSME schemes and government initiatives.
Step 16: Trademark Registration – Optional
Trademark Registration is not mandatory to start a diagnostic centre, but it can help protect the centre's: -
It may be particularly useful if you plan to establish multiple branches or build a recognised diagnostic brand.
If the centre offers specialised services or undertakes additional activities, other compliance requirements may apply.
For example, AERB requirements may apply to X-ray, CT and mammography equipment, while ultrasound services covered by the PC-PNDT Act require applicable registration and record-keeping.
A separate Drug Licence may be required if the centre operates a pharmacy or dispenses/sells medicines requiring a licence.
If diagnostic equipment is directly imported, applicable DGFT and Customs requirements should be considered. Appropriate e-waste compliance may also apply when covered electronic equipment is discarded.
The centre should also maintain appropriate safeguards for patient and health-related data under applicable data-protection requirements.
NABL or NABH accreditation may be considered where relevant as an optional quality/accreditation measure; it should not be presented as a universal licence required to start every diagnostic centre.
The exact documents depend on the business structure and diagnostic services proposed. Common documents may include: -
The final document checklist should be prepared according to the services and equipment proposed for the diagnostic centre.
Proper registration and compliance can help your diagnostic centre: -
Estimated Timeline
The time required to establish a diagnostic centre depends on the business structure, premises, services, equipment and applicable approvals.
A basic pathology or sample-collection centre may have a different timeline from a facility requiring AERB-related approvals or PC-PNDT registration.
Therefore, it is advisable to identify the applicable approvals before purchasing equipment or commencing operations.
Government Fees
Government fees vary depending on the registration, licence or approval involved.
The applicable costs may depend on factors such as: -
Since fees and procedures may change, the applicable government charges should be verified at the time of filing.
Starting a diagnostic centre involves several registrations and compliances that depend on the services you plan to provide. Choosing the wrong registration or overlooking an activity-specific approval can create unnecessary delays.
Remind Legal LLP assists entrepreneurs with business registration, documentation and applicable regulatory compliance for establishing a diagnostic centre in Delhi.
Our Services Include: -
Planning to start a diagnostic centre in Delhi? Contact Remind Legal LLP for assistance with the registrations and compliances applicable to your centre.