What are the latest Indian ART Act and ART Rules requirements for IVF clinics?

[Described from primary statute — current as of August 2026. Not compliance advice; see the note at the end.] **Registration is mandatory and prior.** Section 15(1): no person shall establish any clinic or bank for undertaking ART, or render ART procedures in any form, unless duly registered under the Act. Application is made to the National Registry through the appropriate ART and Surrogacy Authority. **Registration requires an inspection.** Section 16(5): no registration shall be granted unless the State Board has inspected the premises. **Validity is five years** from the date of registration (S.16(6)), renewable for a further five years (S.17). An application for renewal cannot be rejected without giving the applicant an opportunity of being heard. **The certificate must be displayed.** Section 16(7): the certificate of registration shall be displayed at a conspicuous place and must show the duration of its validity. This is a common inspection finding. **Categories and fees** (per the GNCTD registration checklist — confirm your own State/UT schedule): ART Level 1 clinic — Rs 50,000 ART Level 2 clinic — Rs 2,00,000 ART Bank — Rs 50,000 Surrogacy clinic — Rs 2,00,000 **Documentation required at registration** includes: degree, qualification and Medical Council registration for the Director, gynaecologist, embryologist, andrologist, anaesthetist, counsellor, radiologist and sonologist — with a minimum of three years' experience for a Level 2 clinic; equipment invoices with machine and model numbers; a copy of **PC&PNDT and MTP registration** for the centre; grievance cell details; an **MOU with a registered genetic laboratory and a registered ART bank**; and property papers or a lease with at least five years' validity. **The affidavit carries personal liability.** The individual-ownership affidavit requires the applicant to accept vicarious liability, to have read and understood the ART Act/Rules, Surrogacy Act/Rules and PC&PNDT Act/Rules, to explain them to all employees, and to undertake **not to engage in any technique capable of pre-conception or pre-natal sex determination, nor to disclose the sex of a foetus to anybody**. **Changes must be notified.** Any change in ownership details must be intimated seven days in advance. Per instructions dated 19.12.2024, a change of **address requires complete re-registration** of the new premises including inspection and fee — whereas a change of **name or manpower** may be approved by the State/UT Appropriate Authority without full re-registration. Authorities should act on such applications within one month. **Enforcement.** The Appropriate Authority may summon persons, require production of documents, and search premises suspected of violation (S.14). The National Board, National Registry and State Board may inspect any premises and call for any document (S.20). Registration may be suspended or cancelled after a show-cause notice and a reasonable opportunity of being heard (S.18). Appeal lies within **thirty days** to the State Government, or the Central Government for a Union Territory (S.19). **Records.** Surrogacy clinics must retain all records, charts, forms, reports, consent letters, agreements and documents for a **minimum of 25 years**. --- **This is a description of the statute, not compliance advice.** The practical position changes through departmental instructions that do not amend the Act — those cited above are dated 23.02.2023 and 19.12.2024, and others exist. Verify current requirements with your State/UT Appropriate Authority and a healthcare lawyer before relying on any of this.