Compliance guide · Updated October 2026

The ART Act, Clause by Clause

What the Assisted Reproductive Technology (Regulation) Act 2021 asks of an Indian clinic or bank, in the order an inspector checks it, and where each duty lives inside ConceiveX.

2021

Act passed, in force Jan 2022

Rules notified June 2022. National Board and State Boards constituted.

2 tiers

Level 1 and Level 2 clinics

IUI-only centres register at Level 1. Anything with an embryology lab is Level 2.

10 yrs

Record retention

Every record and consent kept for ten years from the date of the procedure.

5 yrs

Registration validity

Renew before expiry. Late renewal means no new cycles until the certificate is reissued.

The guide

Six Duties, in Inspection Order

01

Register the clinic and the bank

Sec 15 to 21

No clinic or ART bank may operate without registration from the State Board, renewed every five years. Level 1 covers IUI-only centres. Any facility with an embryology lab is Level 2 and must name its embryologist, gynaecologist and andrologist on the certificate.

What an inspector asks for

  • The registration certificate, displayed in the reception
  • Staff register with qualifications of named personnel
  • Equipment list matching the application

Where it lives in ConceiveX

  • Clinic profile stores certificate number, level and expiry with a 180-day renewal alert
  • Staff directory tags the three statutory roles
  • Equipment register exports in the Board format
03

Source gametes only through a registered ART bank

Sec 27 and 28

Oocyte donors must be 23 to 35, donate once in a lifetime and no more than seven oocytes retrieved. Sperm donors 21 to 55. Screening, insurance for oocyte donors and the bank-to-clinic transfer record are all mandatory.

What an inspector asks for

  • Bank registration for every donor sample used
  • Donor age, screening dates and insurance proof
  • One-donation-per-lifetime declaration

Where it lives in ConceiveX

  • Donor inventory holds screening, quarantine and insurance fields and blocks release until cleared
  • Straw-level chain of custody from bank to transfer
  • Age and donation-count rules enforced at registration
04

Keep every record for ten years

Sec 29 and 30

Clinics and banks must maintain records of every procedure, donor, recipient and outcome for ten years, in a form the Board can inspect. Confidentiality is a duty of its own, with disclosure permitted only by court order or to the couple.

What an inspector asks for

  • Retrieval of a random cycle from more than five years ago
  • Access logs showing who opened a record and when
  • Backup and retention policy

Where it lives in ConceiveX

  • Immutable audit log on every record, exportable per cycle
  • Retention tagging stops deletion before the ten-year mark
  • Role-based access with per-record view history
05

Report to the National Registry

Sec 9 and Rules Chapter IV

Every clinic must submit cycle, outcome and adverse-event data to the National ART and Surrogacy Registry in the format and frequency the Board prescribes. Reporting is not optional and the data must reconcile with your own records.

What an inspector asks for

  • Registry submission receipts for the last reporting period
  • Reconciliation between registry totals and the clinic register
  • Adverse-event filings with dates

Where it lives in ConceiveX

  • Registry export pre-fills from cycle data and flags gaps before submission
  • Submission receipts stored against the period
  • Adverse events logged from the clinical note with a filing reminder
06

Know what the Act forbids outright

Sec 25, 26 and 31

Sex selection, trading in gametes or embryos, abandoning or selling children born through ART, and offering ART to anyone outside the eligibility age bands are offences with no cure. Eligibility is 21 to 50 for women and 21 to 55 for men.

What an inspector asks for

  • Eligibility checks recorded at intake
  • PGT indications documented as medical, never sex-based
  • No advertisement promising sex selection

Where it lives in ConceiveX

  • Intake blocks ineligible ages with an override that requires a reason
  • PGT orders carry a mandatory indication field
  • Marketing templates reviewed against Sec 26 language

Self-audit

Twelve Checks Before the Inspector Does

Tick what is already in place. Your answers update the readiness score at the top of the page and stay in this browser.

Ready0 / 12
01Registration0 / 2
02Consent0 / 2
03Donors and banks0 / 2
04Records0 / 2
05Reporting0 / 2
06Prohibitions0 / 2

Deadlines that recur

The Compliance Calendar, Cycle to Renewal

Every cycle

Consent before each step

Retrieval, insemination, transfer, freezing and disposal each need their own signed form.

Within 24 hours

Adverse-event note

Record OHSS admissions and procedure complications the same day. File to the registry in the period.

Each period

Registry submission

Cycle and outcome data to the National Registry in the Board format, with receipts kept.

Annually

Internal audit and staff review

Re-run this self-audit, refresh staff qualifications and review marketing language.

Every 5 years

Registration renewal

Apply well before expiry. No new cycles may start on a lapsed certificate.

Why it matters

What Non-Compliance Actually Costs

Chapter VII of the Act sets penalties per offence, not per clinic. A single unregistered cycle, an unsigned consent or a missing donor record each counts on its own.

₹5 to 10 lakhOperating without registrationFirst offence. Subsequent offences rise to ₹10 to 20 lakh with imprisonment of up to eight years.
₹5 to 10 lakhBreach of consent, record or reporting dutiesApplies per contravention. Repeat offences add suspension or cancellation of registration.
₹10 to 20 lakhSex selection or trading in gametesPlus imprisonment of five to eight years for medical practitioners and the clinic owner.
CancellationRegistration suspended or cancelledThe Board may act on inspection findings alone, before any court proceeding.
ART Act compliance dashboard with audit checklist and compliance report

The prescribed forms

Seven Consent Forms,
One per Decision

The 2022 Rules name a form for each step. One signature never covers the next. Each is pre-filled and e-signed in ConceiveX, in Hindi and English.

Form 8Couple

Consent for ART procedure

The umbrella consent for treatment at a registered clinic, including risks, success rates and costs.

Signed Before the first cycle starts

Form 9Couple

Consent for oocyte retrieval

Covers stimulation, anaesthesia and the retrieval itself, with the planned number of oocytes.

Signed Before stimulation begins

Form 10Couple

Consent for IUI, IVF or ICSI

The insemination or fertilisation method chosen, and the reason for choosing it.

Signed Before gametes are handled

Form 11Couple

Consent for embryo transfer

Number of embryos to transfer, the policy on multiples and what happens to the rest.

Signed Before each transfer

Form 12Couple

Consent for cryopreservation

Storage of gametes or embryos, the storage term, fees and what happens on lapse.

Signed Before freezing

Form 13Donor

Donor consent

Taken by the bank from the oocyte or sperm donor, with screening, insurance and the one-donation rule.

Signed Before donation, at the bank

Form 14Couple

Consent for use of donor gametes

The commissioning couple accepts donor gametes or embryos and the anonymity conditions.

Signed Before a donor cycle

Form 15Couple

Consent for withdrawal or discard

Withdrawing a consent already given, or discarding stored gametes or embryos, with the reason recorded.

Signed Before any discard or withdrawal

Pricing

Compliance Built In, at Every Plan Level

Every plan carries the ART Act essentials from this guide, prescribed consent forms, a ten-year audit log and registry-ready exports. Higher tiers add donor controls, multi-centre reconciliation and inspection support.

Save ₹200/mo annually

Starter

5–25 licences

Level 1 clinics and IUI centres

₹1,700 /month

Billed monthly

Get Started
  • Couple record with ART Act eligibility check
  • Consent Forms 8 to 11, pre-filled and e-signed
  • Counselling record before every consent
  • Ten-year record retention and access log
  • Registration certificate expiry alerts
  • 6 staff logins with statutory role tags
  • 24 hrs/year compliance support
  • 3 hrs ART Act onboarding
MOST POPULAR

Growth

25–100 licences

Level 2 clinics with an embryology lab

₹1,500 /month

Billed monthly

Get Started

Everything in Starter, plus

  • Cycle gating, no step without its consent
  • Forms 12 to 14 for cryo and donor use
  • National Registry export with gap check
  • Adverse-event log with filing reminder
  • Named embryologist, gynaecologist, andrologist on file
  • 10 staff logins
  • 48 hrs/year compliance support
  • 5 hrs onboarding incl. mock inspection

Advanced

100–200 licences

Clinics running donor and surrogacy programmes

₹1,300 /month

Billed monthly

Get Started

Everything in Growth, plus

  • Donor age, count and insurance rules enforced
  • Bank-to-clinic straw chain of custody
  • 30 staff logins
  • Donor quarantine release controls
  • PGT indication field, sex-selection block
  • Surrogacy consent and legal document set
  • Inspection-day evidence pack, one click
  • 48 hrs/year compliance support

Enterprise

200+ licences

Chains filing for several centres

Custom pricing

Tailored for your network

Get Started

Everything in Advanced, plus

  • Unlimited staff logins across centres
  • Multi-centre registry reconciliation
  • State Board format variations per centre
  • Annual compliance review with our team
  • Dedicated compliance account manager
  • Priority updates when the Rules change

Our prices are final and non-negotiable to ensure fairness for all our clients.

Teams who used this guide before their inspection

What the Self-Audit Caught Before the Board Did

We scored seven of twelve on the self-audit and fixed the other five in a fortnight, counselling dates, Form 12 for every freeze, a renewal reminder. The State Board visit was forty minutes.
Dr. Meera KulkarniDirector and ART Act compliance lead, Aarambh Fertility Centre, PuneLevel 2 clinic
The donors chapter made us check Form 13 and insurance proof on every straw in the tank. Two older batches had neither. We quarantined them before anyone asked.
Sneha IyerChief Embryologist, Genesis IVF Lab, ChennaiART bank and lab
The reconciliation template showed one centre under-reporting cancelled cycles to the registry. We corrected the filing ourselves, with a cover note, before the period closed.
Rahul MenonGroup CEO, Nurture IVF NetworkSeven-centre chain

Security & Compliance

Power Your IVF Practice with ConceiveX
India’s Secure, Compliant IVF Platform

Patient records, embryology data and billing, protected by healthcare-grade security and national health standards.

NHA Approved

IVF clinic records recognised under India’s digital health standards.

ABDM Compliant

First IVF platform integrated with the ABDM health network.

ART Act Compliant

Built for India’s ART (Regulation) Act, 2021 for IVF clinics and banks.

FHIR Compliant

IVF cycle, lab and patient records interoperable on the FHIR standard.

ICMR Guidelines

Follows ICMR national guidelines for ART clinics and embryology labs.

Rated by compliance and quality teams

Top-Rated for ART Act Compliance

Reviewers single out consent handling, record retention and registry filing, the three duties inspectors check first.

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5.0/5

SoftwareSuggest

Compliance Leader, Winter 2023

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Reviews mention audit readiness

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4.6/5

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Rated for consent management

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Rated for regulatory reporting

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5.0/5

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5 stars for record retention

Before you ask

Questions About the ART Act Guide

TrialWe scored low. What do we do first?

Start with registration and consent, the two chapters the Board checks first and the ones with the heaviest penalties. Download the consent-form pack and the inspection-day checklist above, then book a walkthrough and we will map each gap to a ConceiveX setting. The 14-day trial has every module switched on, with your consents and price list loaded and no card needed.

TrialHow long is the free trial?

Fourteen days, every module switched on, no card. The 14-day trial has every module switched on, with your consents and price list loaded and no card needed.

TrialIs the trial the real product or a demo build?

The real product, with your own consents and price list loaded by a specialist on day one. The 14-day trial has every module switched on, with your consents and price list loaded and no card needed.

TrialCan we add real patients during the trial?

Yes. The data stays if you continue and is deleted on request if you do not. The 14-day trial has every module switched on, with your consents and price list loaded and no card needed.

TrialHow many people can use the trial?

Up to ten logins, enough for a whole single-site team. The 14-day trial has every module switched on, with your consents and price list loaded and no card needed.

TrialDo we get help during the trial?

A named specialist checks in on day one, three and ten, and support is the same seven-day line. The 14-day trial has every module switched on, with your consents and price list loaded and no card needed.

TrialCan the trial be extended?

Yes, by a week if the team has not finished a full cycle on it. Ask your specialist. The 14-day trial has every module switched on, with your consents and price list loaded and no card needed.

TrialWhat happens when the trial ends?

Nothing is deleted. Pick a plan and the same workspace continues. Decline and we delete on request within seven days. The 14-day trial has every module switched on, with your consents and price list loaded and no card needed.

TrialCan we trial only the embryology module?

Everything is on, but you can use just the lab module. Many labs do exactly that. The 14-day trial has every module switched on, with your consents and price list loaded and no card needed.

ComplianceIs this guide a substitute for reading the Act?

No. It orders the duties the way an inspector checks them and points to the sections, but the ART (Regulation) Act 2021 and the 2022 Rules are the authority. Use the guide to find what to read, then read it. Consents, registries and audit trails are built in; the ART Act guide and the lab checklist cover what an inspector asks for.

ComplianceWho should work through the self-audit?

The clinic director with the quality or compliance lead, ideally together with the chief embryologist for the donor and records chapters. It takes about an hour if the evidence is to hand. Consents, registries and audit trails are built in; the ART Act guide and the lab checklist cover what an inspector asks for.

ComplianceWhich forms does ConceiveX pre-fill from the cycle record?

Forms 8 to 14, the clinic and bank registers and the inspection pack, all populated from the couple record so nothing is retyped. Consents, registries and audit trails are built in; the ART Act guide and the lab checklist cover what an inspector asks for.

ComplianceWhich ART Act forms are built in?

Forms 8 to 14, the registers and the inspection pack, pre-filled from the record. Consents, registries and audit trails are built in; the ART Act guide and the lab checklist cover what an inspector asks for.

ComplianceAre consents signed on a tablet legally valid?

Yes. E-signatures with timestamp, device and witness meet the IT Act and the ART Rules. Consents, registries and audit trails are built in; the ART Act guide and the lab checklist cover what an inspector asks for.

ComplianceDoes it handle PCPNDT Form F?

Yes. Form F is generated from the scan record and filed with the monthly return. Consents, registries and audit trails are built in; the ART Act guide and the lab checklist cover what an inspector asks for.

ComplianceHow does witnessing meet the Act?

Barcode double-witnessing at every bench step, logged with both identities and the time. Consents, registries and audit trails are built in; the ART Act guide and the lab checklist cover what an inspector asks for.

ComplianceCan we produce an inspection pack quickly?

One click exports consents, registers and the audit trail for any couple or date range. Consents, registries and audit trails are built in; the ART Act guide and the lab checklist cover what an inspector asks for.

ComplianceDoes it support the ICMR registry?

Yes. Registry submissions export with validation. Consents, registries and audit trails are built in; the ART Act guide and the lab checklist cover what an inspector asks for.

TrainingHow often is the guide updated?

We review it after every notification from the National Board and at least once a quarter. The date at the top of the page is the last review. Clinics on a ConceiveX plan get an email when a change affects a duty in this guide. Training is included: the role videos and the Help Center get a new team member running in an afternoon.

TrainingCan we use the checklist without ConceiveX?

Yes. The twelve-point self-audit is free to print and use. Clinics on ConceiveX see it tracked live against their own records. Training is included: the role videos and the Help Center get a new team member running in an afternoon.

TrainingIs training included?

Yes, in every plan. Two rounds per role during onboarding, then unlimited videos and articles. Training is included: the role videos and the Help Center get a new team member running in an afternoon.

TrainingHow long does training take per role?

About two hours per role, split into short sessions between patients. Training is included: the role videos and the Help Center get a new team member running in an afternoon.

TrainingAre training videos available in Hindi?

Yes. Every role video has Hindi and English versions with captions. Training is included: the role videos and the Help Center get a new team member running in an afternoon.

TrainingCan new staff learn on their own?

Yes. The role track in the Help Center takes a new hire from login to first task in an afternoon. Training is included: the role videos and the Help Center get a new team member running in an afternoon.

TrainingDo you train embryologists separately?

Yes. Lab training is bench-side on your own scanners and label printers. Training is included: the role videos and the Help Center get a new team member running in an afternoon.

TrainingIs refresher training available?

Yes. Monthly webinars, and your success manager can schedule a refresher any time. Training is included: the role videos and the Help Center get a new team member running in an afternoon.

TrainingAre there printable guides?

Yes. Checklists and one-page guides for the front desk, nursing, lab and billing. Training is included: the role videos and the Help Center get a new team member running in an afternoon.

ProductHow is the readiness score calculated?

Each of the twelve self-audit checks counts equally. Two checks map to each of the six chapters. A chapter shows as complete when both are ticked and half when one is. Your ticks stay in this browser only. Nothing is sent to us. See it on your own workflows in a 45-minute demo, configured for your clinic type before you join.

ProductWhat does ConceiveX do?

It runs an IVF clinic on one record: EMR, cycle tracking, embryology lab, billing, consent, cryo, pharmacy and a patient app. See it on your own workflows in a 45-minute demo, configured for your clinic type before you join.

ProductWhich modules are included?

All twelve, in every plan, at one per-login price. See it on your own workflows in a 45-minute demo, configured for your clinic type before you join.

ProductDoes it work when the internet drops?

Core screens keep working on a lost connection and sync when it returns. See it on your own workflows in a 45-minute demo, configured for your clinic type before you join.

ProductIs there a mobile app for staff?

Yes. Doctors and managers get iOS and Android apps, and the full product runs in any browser. See it on your own workflows in a 45-minute demo, configured for your clinic type before you join.

ProductCan we customise forms and templates?

Yes. Consents, protocols, reports and price lists are templates you own. See it on your own workflows in a 45-minute demo, configured for your clinic type before you join.

ProductWho is ConceiveX built for?

IVF centres, chains, fertility hospitals, embryology and andrology labs, gamete banks, surrogacy programmes and gynaecology clinics. See it on your own workflows in a 45-minute demo, configured for your clinic type before you join.

ProductHow often is the product updated?

Monthly, with no downtime and no extra charge. See it on your own workflows in a 45-minute demo, configured for your clinic type before you join.

ProductCan we see it before we commit?

Yes. A 45-minute demo on your own workflows, then a 14-day trial. See it on your own workflows in a 45-minute demo, configured for your clinic type before you join.

Growth for a 10-login IVF clinic: ₹1,500 a login, ₹15,000 a month, plus GST.Full pricing ›Compare ConceiveX ›

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