Under the ART Act 2021, an IVF clinic reports enrolment, procedures and outcomes or complications to the National Registry at regular intervals. Once the Registry is live, detailed records of donor oocytes, sperm and embryos are submitted online within one month, and records stay available for inspection. The practical job is to keep those records complete as the work happens, so every report is drawn from them rather than rebuilt.
Reporting is the duty clinics most often leave until it is due. It is also the one that exposes gaps fastest, because a report can only contain what the clinic recorded. This post turns the reporting duty in the ART Act 2021 into a checklist a clinic can work through before a deadline arrives.
For the wider set of duties the Act places on a clinic, read our guide to ART Act 2021 compliance.
The National Registry sits at the centre of the Act. Every ART clinic and every ART bank registers through the appropriate authority with the National Registry (s.15-16), and the same Registry receives the clinic's reports.
For a clinic, that makes the Registry both the place it is registered and the place it answers to. Registration is inspected by the State Board before it is granted, and reporting carries on for as long as the clinic operates.
Two parts of the Act set out what goes to the Registry. Section 21(j) requires periodic reporting of enrolment, procedures and outcomes or complications. Section 23 requires detailed records of donor oocytes, sperm and embryos, submitted online once the Registry is live.
| What is reported | Where in the Act | When |
|---|---|---|
| Enrolment | s.21(j) | At regular intervals |
| Procedures | s.21(j) | At regular intervals |
| Outcomes or complications | s.21(j) | At regular intervals |
| Records of donor oocytes, sperm and embryos | s.23 | Online within one month, once the Registry is live |
Once the National Registry is live, the information under s.23 is submitted online within one month. A month sounds generous until the records are spread across paper registers, spreadsheets and laboratory notebooks.
The clinics that meet the window comfortably are the ones that record each event when it happens. Then the submission is an export from records that already exist, not a reconstruction from memory.
The Act ties the one-month online submission to the Registry being live. A clinic should not read that as a reason to wait. The records behind the submission are the same detailed records the clinic must keep anyway, so building the habit now means the online duty, when it applies, changes how the data is sent rather than how it is kept.
Reporting is not the end of a record's life. Records are kept for at least 10 years and then transferred to the central database, and they must be available for inspection (s.23).
That means a report and the record behind it should agree years later. If an inspector asks how a reported outcome was arrived at, the answer has to come from the clinic's own documentation.
Work through these before each reporting cycle:
Every enrolment is recorded at the time, against the right patient.
Every procedure is logged with the date, the time and the person who carried it out.
Outcomes or complications are recorded against the cycle they belong to.
Donor oocytes, sperm and embryos each carry unique identifiers and a clear source.
Written consent from all parties is on file before treatment began (s.22).
The data for a submission can be exported from one place.
Records are retained for at least 10 years and stay available for inspection.
Vitrify supports export and reporting for the National ART and Surrogacy Registry, drawn from the records the clinic already keeps. Structured record keeping with long retention keeps those records whole, and an audit trail shows who entered what and when. Electronic witnessing and gamete and embryo traceability with unique identifiers tie each sample to its source.
Day to day, the EHR and EMR holds the clinical record, and real-time analytics help a team see where a record is incomplete before a report is due. The duty to report stays with the clinic. Software makes the report easier to produce and easier to stand behind.
Accreditation points the same way. The draft NABH accreditation standard for ART clinics, first edition 2025, asks for regular reporting of gamete and embryo data to the National ART and Surrogacy Registry; read more in our guide to NABH compliant IVF software. If you are comparing systems, see our guide to the best IVF software in India and our IVF software pricing.
Enrolment, procedures and outcomes or complications, reported at regular intervals under s.21(j) of the ART Act 2021.
Once the National Registry is live, the information under s.23 is submitted online within one month.
At least 10 years, after which they are transferred to the central database. They must be available for inspection (s.23).
The draft NABH accreditation standard for ART clinics, first edition 2025, asks for regular reporting of gamete and embryo data to the National ART and Surrogacy Registry (COP.8f). It is still a draft, and general NABH hospital accreditation is what applies today.
Software supports export and reporting drawn from the records the clinic keeps. The duty to report stays with the clinic.
Registry reporting rewards the clinic that records as it goes. Report enrolment, procedures and outcomes or complications at regular intervals, be ready to submit online within one month once the Registry is live, and keep every record available for inspection for at least 10 years. Start from Vitrify IVF software, browse the IVF software modules or find IVF software for your clinic type. To see clinics on the national ART registry in India, browse the IVF clinic directory, Vitrify Explore. Book a demo to see how Vitrify turns everyday records into Registry-ready reports.
