ART Act 2021 Compliance for IVF Clinics: The Records You Must Keep, and How ARTis Keeps Them Ready

Every IVF clinic in India works under the Assisted Reproductive Technology (Regulation) Act, 2021, and the ART Rules of 2022. The Rules have been amended several times since, most recently in June 2026. Much of what the law asks for comes down to one thing: records. Consents, cryo storage, donors, outcomes and reports to the National Registry all have to be accurate, complete and available whenever the Appropriate Authority or the National Registry asks for them.

This guide walks through the main records the law expects a clinic to keep. For each one, it covers what the law requires, where clinics usually slip, and how ARTis keeps that record ready.

Registration and renewal

Every ART clinic and ART bank must be registered with the National ART and Surrogacy Registry. The registration certificate is valid for five years. Under the June 2026 amendment, clinics must apply for renewal on the Registry portal at least 60 days before the certificate expires, and a late application attracts an additional fee.

Before it registers or renews a clinic, the Appropriate Authority inspects it, and that inspection looks at the records described below.

Eligibility and counselling

What the law requires. The Act sets age limits for treatment: the woman must be between 21 and 50, and the man between 21 and 55. Before treatment, the clinic must counsel the couple or woman on the procedure, its chances of success, its risks and its costs.

Where clinics slip. Counselling happens, but nothing is written down. Ages are noted on paper and never checked again.

How ARTis keeps it ready.

• The ages of the woman and the man are recorded from registration, and ARTis flags a patient outside the age limits.
• Counselling sessions are recorded in the patient’s file, with the counsellor, the date and the notes.
• ARTis flags a procedure when counselling has not been recorded for that patient.

Written consent before every procedure

What the law requires. No ART procedure can be carried out without the written informed consent of all the parties involved. The ART Rules prescribe the consent forms clinics must use, for example for oocyte retrieval, for freezing embryos or gametes, and for the use of donor gametes.

Where clinics slip. An old or wrong form is used, a signature is missing, or the signed form is in a paper file that can’t be found when the inspector asks for it.

How ARTis keeps it ready. ARTis provides consent templates in line with the ART Rules for IUI, IVF and every other procedure. Each form is pre-filled with the patient’s details, and the signed copy is saved in the patient’s file, so it can be produced in seconds.

Consent before freezing, and storage renewals

What the law requires. Embryos and gametes can be frozen only with specific written instructions and consent from all parties. Stored samples need a clear record of what was frozen, for whom, and for how long.

Where clinics slip. Storage periods run out without anyone noticing. Patients are not reminded. Samples sit in tanks past their consented period, with the paperwork out of date.

How ARTis keeps it ready.

• The freezing consent is saved in the patient’s file, alongside the record of each frozen sample.
• The expiry date is calculated automatically when the sample is frozen.
• Patients receive automatic WhatsApp reminders before their storage period ends.
• Each renewal is recorded on the sample, and the renewal invoice is raised automatically.

For more on how ARTis manages the lab and cryo storage, see our guide to IVF lab and cryo management software.

Accurate records for at least ten years

What the law requires. Clinics must keep accurate records of all oocytes, sperm and embryos, used or unused, and how they were used. No more than three embryos can be transferred to a woman in one treatment cycle. Records must be kept for at least ten years, after which they are transferred to the National Registry. If legal proceedings are pending, records must be kept until they end.

Where clinics slip. Records are spread across registers, spreadsheets and separate systems for the clinic, the lab and billing. After a few years, staff change and nobody can piece together what happened to a particular embryo.

How ARTis keeps it ready.

• One cycle record from stimulation to outcome, covering every stage of IVF cycle management.
• Cryo storage recorded down to the exact tank, canister, cane and straw.
• Total, used and available counts for every freezing, so nothing goes unaccounted for.
• The number of embryos transferred in every cycle, recorded in the cycle itself.
• Daily cloud backup, so records are not lost with a damaged register or a failed computer.

Reporting to the National Registry

What the law requires. Clinics must submit information about the progress of each couple or woman to the National Registry online, within one month of receiving that information. They also report donor numbers: how many sperm and oocyte donors were screened, maintained and supplied.

Where clinics slip. Staff compile the report by hand from several registers, which takes time and invites mistakes. Reports are filed late, or figures don’t match the clinic’s own records.

How ARTis keeps it ready. ARTis produces the National ART Registry report, including donor numbers, from data the clinic has already recorded during treatment. Clinic staff review it and submit it on the Registry portal. Staff don’t have to compile the figures by hand.

Donor records

What the law requires. Donor gametes can be obtained only through a registered ART bank. Clinics must keep a record of donor gametes received and used, and donors must meet the screening and eligibility rules set out in the Act and Rules. An oocyte donor can donate only once in her life, and no more than seven oocytes can be retrieved from her.

Where clinics slip. Donor details sit in a separate file, disconnected from the recipient’s treatment record. It becomes hard to show which donor’s gametes were used for which recipient, and whether every check was done.

How ARTis keeps it ready.

• A donor master, with a case file for each donor.
• Donors linked to the recipients their gametes were used for.
• Donor flags that alert the team to a donor who has already donated or whose screening is incomplete.

Right sample, right patient

Every record above depends on one thing being true: that each dish, tube and straw belongs to the patient it is labelled for. A single mix-up undermines every consent and record the clinic holds. Inspectors also look at who witnessed each critical step, and whether that check was recorded.

ARTis Sentinel checks this electronically at every critical step:

• Each dish and tube carries a QR label, scanned with an ordinary phone or tablet.
• The patient’s name is read aloud at each scan.
• A photo is captured with the time and the name of the person who did the check.
• A wrong scan stops the workflow until it is reviewed and approved.

Sentinel works inside the patient’s case file: each cycle carries its own witnessing workflow, and every check is recorded there. So the clinic can show not only what was done, but that it was done to the right sample. Clinics using ARTis and Sentinel work in both with one login.

Storage conditions

What the law requires. The Rules set standards for cryo storage, including designated storage areas and alarms on cryo storage tanks.

Where clinics slip. Alarms may sound, but there is no written record that the tanks were checked every day, or of what was done when a reading was missed.

How ARTis keeps it ready. Staff record equipment readings in ARTis, such as liquid nitrogen levels, at set times each day against an acceptable range. Each reading is marked compliant, non-recorded or non-compliant, so a missed check or an out-of-range reading stands out. This record sits alongside the clinic’s alarm systems; it does not replace them.

Ready for inspection

During an inspection, the clinic is asked to produce a patient’s complete record: consents, treatment, lab and cryo records, and reports. When records sit in different registers and systems, finding them takes time, and gaps show.

How ARTis keeps it ready.

• One patient file: consents, treatment, lab and cryo records, and reports are pulled up in one place.
• Audit trail: every change to a record is logged with the old value, the new value, the user and the time, so the clinic can show who recorded what, and when.
• Access logs: every login is recorded with the time and IP address.
• Role-based access: staff see and change only what their role allows.

At a glance: what ARTis keeps ready

What the law expects	What ARTis keeps
Eligibility and counselling	Age-limit flag; counselling recorded, with a flag when it is missing
Written consent before every procedure	Consent templates in line with the ART Rules, pre-filled and saved in the patient’s file
Consent before freezing	Freezing consent saved in the patient’s file; expiry, renewals and reminders tracked for each sample
Accurate records for at least 10 years	One record from stimulation to outcome; embryos transferred per cycle; cryo location to the straw; daily cloud backup
Reporting to the National Registry	Registry report, including donor numbers, produced from recorded data
Donor records	Donor master, donor-recipient links and donor flags
Right sample, right patient	Sentinel witnessing inside each cycle: who checked, when, with a photo
Storage conditions	Equipment readings logged at set times, with missed and out-of-range readings flagged
Records ready for inspection	Complete patient file in one place, with audit trail, access logs and role-based access

CASE STUDY Ritu IVF, Jaipur runs its clinic on ARTis. As patient volumes grew, Mr. Jyoti Bansal used ARTis to see where growth came from, keep patients engaged between visits and protect revenue at the billing desk, with every record kept in one system. Read the Ritu IVF case study →

Frequently asked questions

What records does the ART Act require an IVF clinic to keep?

Clinics must keep accurate records of every oocyte, sperm and embryo, used or unused, along with signed consents, donor records and the treatment given to each couple or woman. These records must be available to the Appropriate Authority and the National Registry when asked.

How long must ART clinic records be kept?

At least ten years. After that, records are transferred to the National Registry. If legal proceedings are pending, records must be kept until they end.

Which consent forms are prescribed under the ART Rules?

The ART Rules 2022 prescribe specific consent forms for procedures such as oocyte retrieval, freezing of embryos and gametes, and the use of donor gametes. Written consent of all parties is needed before any ART procedure. ARTis provides consent templates in line with the ART Rules for IUI, IVF and every other procedure.

How often do clinics report to the National ART Registry?

Clinics submit information about the progress of each couple or woman online to the National Registry, within one month of receiving that information. Donor numbers are also reported. ARTis produces the Registry report from data already recorded, and clinic staff submit it.

Can software make a clinic ART Act compliant?

No. Compliance is the clinic’s responsibility. Software such as ARTis keeps the records the Act requires accurate, complete and ready, so the clinic can show them at any time.

See how ARTis keeps your ART Act records ready for inspection. Book a 30-minute demo

References

• The Assisted Reproductive Technology (Regulation) Act, 2021. Government of India.
• The Assisted Reproductive Technology (Regulation) Rules, 2022. Ministry of Health and Family Welfare, notified 7 June 2022, and later amendments.
• ART (Regulation) Amendment Rules, 2026, GSR 491(E), June 2026.
• National ART and Surrogacy Registry.