ART Act registration for IVF and fertility clinics

If you run an IVF or fertility clinic in India, you must register under the Assisted Reproductive Technology (Regulation) Act, 2021 before you offer any ART service. The Act is explicit: no clinic or bank may provide assisted reproductive technology in any form unless it is duly registered. Registration happens on the National ART and Surrogacy Registry, through the appropriate authority appointed for your state or union territory.

This is a specialty regime that sits on top of, not instead of, your general clinic licensing. You still need clinical establishment registration and, if you have an ultrasound, PCPNDT. The ART Act adds its own boards, registry, authorities, registration levels and duties on records, consent and genetic testing. This guide walks through what a fertility clinic actually has to do. For how it fits the wider picture of regimes only some clinics hit, see the pillar on specialty clinic compliance in India.

Two laws, passed together

The ART Act did not arrive alone. It was enacted alongside the Surrogacy (Regulation) Act, 2021, and the two are designed to work as a pair. The ART Act is ACT No. 42 of 2021, dated 18 December 2021. Its companion governs surrogacy arrangements specifically. Both share a common administrative spine: the same National and State Boards, the same appropriate authorities, and a single National ART and Surrogacy Registry.

If your clinic only does IVF, ICSI, IUI and gamete or embryo work, the ART Act is your primary regime. The moment you facilitate surrogacy, the Surrogacy Act comes into play as well. The practical takeaway is to read the ART Act as your baseline and treat surrogacy as a separate, additional layer of compliance, not something you can fold into your ART registration.

ART clinic or ART bank? Know which you are

The Act splits the sector into two kinds of entity, and the distinction decides how you register.

• An ART clinic is premises equipped with the required facilities and medical practitioners registered with the National Medical Commission, carrying out ART procedures. This is where treatment happens.
• An ART bank is the organisation responsible for collecting, screening and storing gametes and embryos, and supplying gametes to ART clinics or their patients. A bank does not perform treatment.

These are distinct under the Act and each must hold its own registration. Many fertility centres operate both functions under one roof. If that is you, do not assume one registration covers both. Confirm with the appropriate authority how the clinic and the bank functions are each to be registered for your setup.

Clinic levels: Level 1 vs Level 2

ART clinics are not registered as a single undifferentiated category. They are classified by the scope of work they do, which determines the registration you apply for.

	Level 1 clinic	Level 2 clinic
Typical scope	Basic infertility work, intrauterine insemination (IUI) only	Advanced procedures: IVF, ICSI, embryo transfer, surgical retrieval of gametes
Who it suits	Gynaecology or fertility OPDs doing IUI	Full IVF laboratories
Fee and exact scope	Prescribed in the ART Rules	Prescribed in the ART Rules

The precise list of permitted procedures and the registration fee for each level are set in the ART Rules, and fees prescribed in rules are revised from time to time. So decide your level honestly against the procedures you actually intend to perform, then verify the current scope and fee with your appropriate authority before applying. Registering as Level 1 and then quietly doing IVF is exactly the kind of mismatch an inspection is designed to catch.

Who regulates you: boards, registry, authority

The Act builds a layered structure. It helps to know who does what so you contact the right office.

• National ART and Surrogacy Board advises on policy, sets standards and oversees the system at the central level.
• State ART and Surrogacy Boards coordinate enforcement within each state.
• National Registry is the central database of every ART clinic and bank in the country, established under the Act.
• Appropriate authority is your operational contact. Appointed at the state or union territory level, it grants, renews, suspends and cancels registrations, inspects premises, and is where your application is decided.

For day-to-day registration, the appropriate authority for your state is the office you deal with, and the National Registry is the portal your record lives on.

How registration works, in practice

Registration follows the sequence in Chapter III of the Act (sections 15 to 18): application, grant, renewal, and suspension or cancellation. In practice the flow looks like this.

1. Get your foundations in order first. Registration is granted to an establishment that meets standards on qualified staff, infrastructure and diagnostic capability. Sort your clinic licences and clinical establishment registration before you apply. If you do pre-implantation genetic testing, line up PCPNDT too (more below).
2. Apply through the National Registry to the appropriate authority. The application is made on the registry and submitted to the appropriate authority for your state or UT.
3. Inspection and grant. The authority may inspect your premises. On meeting the requirements, registration is granted.
4. Renew before it lapses. Registration is generally granted for five years and may be renewed for a further five years. It can be suspended or cancelled for contravention of the Act.

Existing clinics were given a window after the Act commenced to apply for registration. If you are reading this as an established centre that never completed it, treat that as an open exposure and regularise it with your appropriate authority. Timelines, fees and the exact application steps are set in the Rules and administered at state level, so confirm the current procedure locally rather than relying on a generic checklist.

For the general clinic-opening sequence that sits underneath all of this, see how to start a clinic in India.

Your ongoing duties: records, consent, genetic testing

Registration is the start, not the finish. Chapter IV of the Act sets continuing duties that an inspection will test you on.

Records you must keep, for a long time

A registered ART clinic and bank must maintain accurate records of the people enrolled, donors, the procedures undertaken, and outcomes, and share these with the National Registry. Records must be kept for at least ten years, after which they are transferred to the central database of the National Registry. Ten years is a long retention window for a busy IVF lab, so build record-keeping that can actually survive that long and be produced on demand.

Written informed consent

The clinic cannot perform a treatment or procedure, or use human reproductive material or an embryo, without the written informed consent of all the parties to whom the ART applies. Consent here is not a single signature at intake. It attaches to the specific procedure and the specific use of gametes and embryos, so your consent documentation has to be procedure-aware, not generic.

Pre-implantation genetic testing and the sex-selection line

This is where the ART Act meets the PCPNDT Act. The two are deliberately linked.

• The ART Act prohibits offering a couple or woman a child of a pre-determined sex, expressly subject to the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994.
• Pre-implantation genetic testing may be used only to screen an embryo for known, pre-existing, heritable or genetic disease. It cannot be used to choose sex.

If your laboratory does pre-implantation genetic testing or embryo biopsy, you are generally expected to also hold PCPNDT registration as a Genetic Clinic. That is a distinct registration with its own Form F discipline and its own appropriate authority, which we cover in the PCPNDT registration guide. Do not treat ART registration as a substitute for it.

Offences and penalties: hedge the numbers, respect the risk

The Act carries an offences chapter (Chapter V). Sex-selective ART and other contraventions attract monetary penalties and, for serious or repeat offences, imprisonment, and registration can be suspended or cancelled. The published penalty figures have differed between the bill and the final Act and are amendable, so we are not going to quote a single rupee range as settled. Verify the current penalty for any specific offence against the Act text and your legal adviser.

The honest summary: this is a regime where the downside is criminal, not just a fine, and it sits next to the equally serious PCPNDT penalties. Compliance is not the place to economise.

Where clinic software fits, and where it does not

Software does not register you. Nothing in your practice-management system files your ART application, talks to the National Registry, or makes you compliant. The registration, the inspections and the legal duties are yours and your appropriate authority's. Be sceptical of any vendor that implies otherwise.

What good clinic software can do is make the record-keeping and consent discipline that the Act demands less fragile. Avinya Plus keeps structured, exportable patient records with a chronological timeline of visits, procedures, prescriptions and documents, which is the kind of organised history you want when records have to survive a ten-year retention window and be produced for the registry. Clinical templates help you capture procedure details consistently rather than as free text. Role-based access means reception, billing and clinicians see only their part of the record. And an audit trail logs every create, update, delete, view and download with the user who did it, so you can show who touched a record and when.

That is support for your compliance, not a compliance certificate. Avinya Plus holds no ART, PCPNDT or other certification on your behalf, and it does not file anything with any authority. Use it to keep the underlying records clean, and keep the registration and the legal duties firmly in your own hands.

To see what licences apply to your specific setup before you even reach the ART layer, run the clinic licence checker.

This guide is general information, not legal advice. ART and surrogacy law is administered partly at the state level and the Rules change, so confirm every figure, level, fee and timeline with your appropriate authority and a qualified adviser before you act.