Chapter IV REGISTRATION AND STANDARDS FOR CLINICAL ESTABLISHMENTS

1. (1) Different standards shall be prescribed by the Government for clinical establishments of different categories and registration shall be granted to the establishments that have standards in each category.
2. (2) The Council shall determine, within a period of two years from the date of commencement of this Act, the first set of standards for ensuring proper healthcare in clinical establishments.

1. (1) The Government shall, by notification, constitute an Authority for each District for registration of clinical establishments with the following members, namely:—
   • (a) District Collector, ex-officio—Chairperson;
   • (b) District Medical Officer (Health), ex-officio— Vice-Chairperson;
   • (c) an officer not below the rank of Assistant Director of Health and Family Welfare Department nominated by the Government who shall be the Convenor of the Authority; 1[(d) District Medical Officer of the Indian Systems of Medicine, exofficio;
   • (e) District Medical Officer of Homoeopathic System of Medicine, ex-officio;
   • (ea) a Dental Surgeon nominated by the Government;]
   • (f) one member whose tenure shall be three years to be nominated by the District Collector from a professional association in the health sector.
2. (2) Notwithstanding anything contained in sub-section (1), for the purposes of provisional registration of clinical establishments under subsection (1) of section 17, the Vice-Chairperson of the Authority shall exercise the powers of the Authority in such manner as may be prescribed.
3. (3) The Authority shall perform the following functions, namely:—
   • (a) grant, renew, suspend or cancel registration of a clinical establishment;
   • (b) ensure compliance of the provisions of the Act and the rules made thereunder;
   • (c) cancel the registration of such clinical establishment where there is imminent danger to public health and the health and safety of patients and staff;
   • (d) prepare and submit reports periodically of such nature as directed by the Council;
   • (e) perform such other functions as may be prescribed.

Every Clinical Establishment shall fulfil the following conditions for the purpose of registration, namely:—

1. (a) shall have the standards according to the category of clinical establishment;
2. (b) the medical and paramedical staff shall have the minimum qualifications fixed by the authorities concerned and advertised by the Council;
3. (c) undertake to mandatorily comply with the orders issued by the Council from time to time, in such form as may be prescribed;
4. (d) undertake to furnish such information to the State Government as notified; 1[(e) undertake to comply with the guidelines issued by the Government from time to time specifying the standard of safety, infection control and method of treatments;]
5. (f) such other conditions as may be prescribed.

¹ Substituted by Act 31 of 2024 ( w.e.f. 19-11-2024).

1. (1) All clinical establishments in Kerala shall be registered with the Authority concerned under the provisions of this Act and the rules made thereunder.
2. (2) No person shall run a clinical establishment unless it has been duly registered in accordance with the provisions of this Act and the rules made thereunder.
3. (3) All clinical establishments functioning at the commencement of this Act shall be granted provisional registration by the Authority concerned.
4. (4) All clinical establishments having provisional registration shall acquire the standards for permanent registration in the category within such period as may be prescribed.
5. (5) All clinical establishments which come into existence after the commencement of this Act shall apply for permanent registration with the Authority within such period as may be prescribed.
6. (6) Where a clinical establishment is offering services in different medical category, such clinical establishment shall apply for separate provisional or permanent registration for each category under this Act: Provided that a laboratory or a diagnostic centre which is a part of a clinical establishment need not be registered separately.

1. (1) Every clinical establishment functioning on the date of commencement of this Act shall apply for provisional registration in such form along with such fee, as may be prescribed.
2. (2) All clinical establishments, whether registered or not under any existing law requiring registration of such establishments, shall apply for registration as referred to in sub-section (1).
3. (3) The Authority shall, within forty five days of the date of receipt of the application, grant to the applicant a certificate of provisional registration in such form and containing such particulars as may be prescribed and if the registration is not granted or declined within this period it shall be deemed to have been granted.
4. (4) If it is found that provisional registration granted under sub- section (3) was given not in accordance with law, disciplinary proceedings may be initiated against the officer responsible for granting or not declining the registration within the said period.

¹ Substituted by Act 31 of 2024 (w.e.f. 19-11-2024).

Provisional registration shall be

valid for 1[four years and six months] from the date of issuance of the certificate of registration.

1. (1) Application for permanent registration of a clinical establishment shall be made to the Authority in such form and in such manner with such fees as may be prescribed, accompanied by such evidence to the effect that the clinical establishment has complied with the standards prescribed for the category.
2. (2) Every clinical establishment having provisional registration shall apply for permanent registration sixty days prior to the date of expiry of the provisional registration.
3. (3) The Authority shall, ensure that the details of clinical establishments that have applied for registration are caused to be published, in the manner as may be prescribed, within a period of seven days from the date of receipt of application.
4. (4) The Authority shall, before granting permanent registration, inspect or cause to be inspected the clinical establishment.
5. (5) Permanent registration shall be granted by the Authority only when a clinical establishment has fulfilled the prescribed standards.
6. (6) The Authority shall, within sixty days of the date of receipt of the application, grant to the applicant a certificate of permanent registration in such form and containing such particulars as may be prescribed and if the registration is not declined or granted within this period it shall be deemed to have been granted.
7. (7) Where the Authority is of the opinion that the clinical establishment has not acquired the standard notified and has submitted incomplete information or if relevant documents are not provided, it shall inform the applicant of its intention to disallow permanent registration with reasons for the same.
8. (8) The applicant shall, within thirty days from the date of communication received under sub-section (7) respond to the Authority and produce evidence to the effect that the standards have been acquired and informations and documents have been submitted and the Authority may, on examination of the evidence and after a re-examination of the evidence by the assessors, if required, either grant or decline the application for registration.
9. (9) Where the Authority decides to decline the application for permanent registration, the reason for the same shall be communicated to the applicant within thirty days of the date of such decision.
10. (10) Rejection of an application for permanent registration shall not be a bar for applying afresh for permanent registration after rectifying the defects and producing the required evidence to show that prescribed standards are being maintained.
11. (11) The Authority shall ensure that the registered clinical establishments maintain the prescribed standards as long as the registration remains valid and the Authority shall call for periodic reports, inspect or cause to be inspected every registered clinical establishment at least once in two years to ensure compliance with the standards prescribed and the results of the inspection shall be made available to the public in such manner as may be prescribed.
12. (12) The Council shall notify a panel of independent assessors to inspect and examine whether the registered clinical establishment adhere to the prescribed standards.
13. (13) Clinical establishments having received accreditation or certification from the National Accreditation Board for Hospitals or National Accreditation Board for Laboratories or any other body approved for this purpose by Government shall be granted permanent registration without inspection as provided in sub-section (4) and such establishments need not be subjected to inspection by the assessors of the Council till such time the accreditation or certification, as the case may be, remains valid: Provided that where the accreditation or certification be cancelled or has expired, the Authority shall cause the clinical establishments to be inspected within a period of thirty days from the date of such cancellation or expiry.
14. (14) Where the clinical establishment has not acquired the standards prescribed, the Authority shall proceed to cancel its provisional or permanent registration in such manner as may be prescribed.

¹ Substituted by Act 8 of 2023 (w.e.f. 01-01-2019).

Permanent registration shall be valid for a period of 1[five] years following which it may be renewed prior to expiry on payment of such fees as may be prescribed.

Application for renewal of

permanent registration shall be made sixty days prior to the expiry of the validity of the certificate of permanent registration and in case the application for renewal is made after the expiry of such date, the Authority may allow such application on payment of such enhanced fees as may be prescribed.

The Authority shall acknowledge

the receipt of the application for provisional registration or permanent registration, as the case may be, in such form as may be prescribed.

1. (1) The Authority shall issue the certificate of provisional or permanent registration, as the case may be, in such form and containing such particulars as may be prescribed. (2)The provisional or permanent registration certificate shall be displayed in a conspicuous place in the clinical establishment.

1. (1) The certificate of registration both provisional and permanent shall be non-transferable.
2. (2) In the event of change in the name of the establishment, ownership, category, management, location or on the cessation of functioning, such clinical establishment shall return the certificate within thirty days to the Authority. 1Substituted by Act 31 of 2024 (w.e.f. 19-11-2024). (3)Where the registration certificate of a clinical establishment is returned under sub-section (2), fresh application shall be submitted to carry on such clinical establishment: Provided that in the case of change of ownership, new application for registration shall be submitted within thirty days from the date of change of such ownership and if new registration is not received the functioning of such clinical establishment shall be restrained.
3. (4) If new services are provided in addition to the services being provided by a clinical establishment, it shall be communicated to the authority concerned and within thirty days from the date of commencement of such services, required standards shall be acquired for such new services and it shall be convinced to the authority.

1. (1) If, at any time, after any clinical establishment has been registered, the Authority or the Council is satisfied that, —
   • (a) the conditions of the registration are not complied with; or
   • (b) the clinical establishment has knowingly or negligently carried out an act that is harmful to the health of the person seeking care from the clinical establishment, it may issue notice to the clinical establishment to show cause why its registration should not be cancelled for the reasons to be mentioned in the notice.
2. (2) Where the Authority or Council is satisfied, after giving a reasonable opportunity to the clinical establishment to be heard, that there has been a breach of any of the provisions of this Act or the rules made thereunder, it may, without prejudice to any other action that may be taken against such clinical establishment, by order cancel its registration.
3. (3) Every order made under sub-section (2) shall take effect,—
   • (i) where no appeal has been preferred against such order immediately on the expiry of the period prescribed for such appeal; and
   • (ii) where such appeal has been preferred and it has been dismissed, from the date of the order of such dismissal: Provided that the Authority, after cancellation of registration, for reasons to be recorded in writing, shall restrain immediately the clinical establishment from functioning, if there is imminent danger to the health and safety of patients.