LICENSING OF PRIVATE MEDICAL CLINICS _g S.L.458.23 1
SUBSIDIARY LEGISLATION 458.23
LICENSING OF PRIVATE MEDICAL CLINICS 
REGULATIONS
10th November, 1995
LEGAL NOTICE 161 of 1995, as amended by Legal Notices 200 of 1996
and 183 of 2003.
Title.
Medical Clinics Regulations.
Interpretation.
requires- 
Cap. 464.
"department" means the Department of Health; 
"clinic" means a private medical clinic; 
"private medical clinic" includes a private hospital and a day
care medical clinic, but does not include a medical practitioner’s
consulting room;
"Ministry" means the Ministry responsible for health;
"Minister" means the Minister responsible for health; 
"authorised person" means a person authorised by the Minister to
exercise powers under regulation 13;
"Superintendent" means the Superintendent of Public Health.
Clinic to comply 
with the provisions 
of these 
regulations.
3. A licence for the opening or carrying on of a clinic under
the Act may only be granted or renewed provided such clinic
complies with the provisions of these regulations. 
Licensing. 
to the Minister in writing and sent or delivered to the Ministry:
Provided that where an application for a licence is already
pending before the coming into force of these regulations, such
application shall be deemed to have been made under these
regulations.
(2) In making an application for a licence for a clinic, an
applicant shall furnish such particulars as are specified in the First
Schedule and such other information as the Minister may require.
(3) Any application for a licence, including the renewal of a
licence, for a clinic shall be accompanied by a fee payable to
Government as the Minister may from time to time by notice in the
Gazette prescribe.
Refusal of licence. 
withdraw a licence in respect of a clinic if he is satisfied -
( a ) that the applicant, or any person employed or proposed
to be employed by the applicant to assume
responsibility for the clinic is not of good conduct; or
2 _g S.L.458.23 LICENSING OF PRIVATE MEDICAL CLINICS
( b ) that for reasons connected with the physical location,
construction, state of repair, accommodation, staffing
or equipment, the clinic is not fit to be used as a clinic;
or
( c ) that the clinic is, or any premises used in connection
therewith are, used, or proposed to be used, for
purposes which are not related to the clinic or which
are in any way improper, unethical or not lawful; or
Cap. 356.
(d) that the clinic or any premises to be used in connection
therewith consist of or include works executed in
contravention of the Development Planning Act; or
( e )  that the arrangements for the management and control
of the services provided at the clinic are not adequate.
(2) Where a licence has been refused or is not renewed or has
been withdrawn, the applicant or licensee, as the case may be, may
within thirty days of receipt of notice of refusal, non-renewal or
withdrawal of licence, appeal to a tribunal to be appointed by the
President of Malta and made up of a person who has, for at least
seven years, been in possession of a warrant to practise the legal
profession in Malta as chairman, and two other members, one from
among the medical profession and the other who shall be a
representative of the department.
Licence to specify 
number of patients 
to be kept.
6. (1) The licence certificate shall specify the number of
patients in beds which may be kept at the clinic.
(2) The type of surgical operations which can be carried out in
a clinic shall be those listed in the Second Schedule and subject to
any conditions specified therein.
(3) The licence certificate issued under the Act in respect of
any clinic shall be kept affixed in a conspicuous place in the clinic.
(4) The tariff of fees chargeable at the clinic in respect of
services, other than professional services provided at the clinic,
shall be kept affixed in a conspicuous place in the clinic.
(5) It shall be the duty of the licensee to ensure that all patients
asking for or receiving a service are informed of the fees
chargeable at the clinic and can receive a copy of the relative fees
charged, which copy shall be given to any person on request.
Licence 
conditions.
7. (1) Where the licence for a clinic is issued on behalf of a
company, it shall be the duty of the licensee to inform the Minister
in writing of any change in the name of the persons running the
company with seven days from such change.
(2) ( a ) No licence for the running of a clinic shall be granted,
transferred or renewed unless the clinic is in the charge
of a medical practitioner or a registered nurse,
hereinafter referred to as "the person in charge".
( b ) It shall be the duty of the licensee to make adequate
arrangements, to the satisfaction of the Superintendent,
for the running of the clinic while he, or, if he is not the
person in charge of the clinic, the person in charge, is
LICENSING OF PRIVATE MEDICAL CLINICS _g S.L.458.23 3
absent from such clinic, and moreover to ensure that
the name of any person at any time in charge of such
clinic is fixed at all times in a conspicuous place and
visible to the public when the clinic is providing a
service. This information is to be communicated
forthwith to the Superintendent.
( c ) If at any time during the absence of the person in
charge there is no person designated as being in
charge, the clinic shall during such time be deemed to
have been operated without a licence.
( d ) It shall be the duty of the licensee to inform forthwith
the Superintendent in writing, and where possible and
practicable in advance, of any change, other than
aforesaid, of the person in charge of the clinic.
( e ) There must be a clear distinction and definition of the
roles and responsibilities of the person in charge and
the licensee in all those instances where these
functions are not carried out by the same person.
Presence of 
medical 
practitioner.
8. It shall be the duty of the licensee to ensure that at all times
in-patients are receiving treatment at the clinic, there is available
resident medical coverage for such patients to the satisfaction of
the Superintendent, taking into consideration the number and
condition of such patients and the service being provided at the
clinic:
Provided that where the surgical operations to be carried
out at the clinic are limited to those listed in Part I of the Second
Schedule, the presence of a registered nurse shall be sufficient.
Duties incumbent 
on licensee.
9. (1) It shall be the duty of the licensee to ensure that there
are present at all times at the clinic a sufficient number of nurses to
ensure proper care of the patients in the clinic taking into
consideration the following:
( a ) the number and category of patients accommodated;
( b ) the number of floors and the number of patients on
each foor;
( c ) the overall layout of the building;
( d ) the facilities provided;
( e ) the number of additional part time staff and of other
staff capable of providing nursing support.
(2) ( a ) Without prejudice to the generality of the above and to
the provisions of subregulation (5), there shall be at
least one registered nurse on duty in each ward or
special unit at all times patients are receiving a service
in such ward or special unit.
For the purposes of this paragraph, no ward or
special unit shall be considered as one such ward or
unit unless it is wholly situated on one floor.
( b ) If a children’s ward or special unit is incorporated
within the clinic there shall be, at all times children are
4 _g S.L.458.23 LICENSING OF PRIVATE MEDICAL CLINICS
receiving treatment, a registered sick children’s nurse
or a registered nurse with significant experience in the
nursing of children.
( c ) Where, in any clinic, surgery is carried out there must
additionally be present at all times such surgery is
carried out and for a reasonable period before and after
such event, a registered nurse with operating theatre
experience:
Provided that patients recovering from an
anesthetic shall be attended to by a qualified
anesthetist or by a suitably trained registered or
enrolled nurse.
(3) ( a ) No patient may be left in the sole charge of a person
who is not authorised to practise as a nurse.
( b ) The number of temporary or casual nurses on duty
shall not exceed the number of permanently employed
nurses on duty and no temporary or casual nurse shall
be in sole charge of a patient unless a permanently
employed registered nurse is present on the premises
and can be called upon immediately.
(4) The person in charge of a clinic shall maintain a roster of
duties of nurses and such roster shall be available to nurses and on
request to an authorised person.
(5) It shall be the duty of the licensee, having regard to the
number, age, sex and condition of patients treated at the clinic, to -
( a ) provide adequate professional, technical, ancillary and
other supporting staff;
( b ) provide for each patient in the clinic adequate
accommodation and space, including, where
appropriate, day room facilities;
( c ) provide adequate furniture, bedding, curtains and,
where indicated, suitable bed screens and door
coverings in rooms occupied or used by patients;
( d ) provide adequate medical, surgical and nursing
equipment and adequate treatment facilities, including
an efficient nurse/patient call system;
( e ) provide for the use of patients adequate wash hand
basins and baths or, where acceptable, showers,
supplying hot and cold water and a suitable number of
water closets and sluicing facilities;
( f ) provide adequate lighting, heating and ventilation in
all parts of the clinic occupied or used by patients;
( g ) keep all parts of the clinic in good structural repair,
clean and reasonably decorated;
( h ) ensure that adequate facilities exist, and take adequate
precautions, against the risk of fire, including the
provision of adequate means of escape in the event of
a fire, as well as make adequate arrangements for
LICENSING OF PRIVATE MEDICAL CLINICS _g S.L.458.23 5
detecting, containing and extinguishing a fire, for
notices regarding procedure to be used in case of fire
and for the giving of warnings, for the evacuation of
the patients and staff, for the maintenance of fire
fighting equipment, and for such other arrangements
as may in any case be required by law, and, in the
absence of any such law, as may, at any time, be
directed by the Commissioner of Police;
( i ) provide adequate kitchen equipment, crockery and
cutlery and adequate facilities for the preparation and
storage of food; 
( j ) supply adequate food for every patient in accordance
with such patient’s dietary requirements;
( k ) arrange appropriate laundering facilities;
( l ) make adequate arrangements for the disposal of swabs,
soiled dressings, instruments and similar substances
and materials as well as for any other hazardous
wastes;
( m ) make adequate arrangements, as may be indicated, in
respect of long stay patients;
( n ) make adequate arrangements for the recording,
safekeeping, handling and disposal of drugs;
( o ) provide adequate arrangements for the prevention of
infection, toxic condition, or the spread of infection in
the clinic;
( p ) take adequate precautions against the risks of
accidents; 
( q ) provide for adequate insurance coverage of patients
treated, and of employees working, at the clinic and
for insurance of third parties in each case in respect of
accident or other mishap.
(6) The number at domestic staff shall be sufficient to ensure a
high standard of cleanliness in all parts of the premises and the
licensee shall ensure that such staff is supervised by a person with
knowledge of cleaning methods and materials applicable to a clinic.
(7) There shall be a supply of wholesome drinking water at
suitable points.
(8) Every clinic shall be provided with adequate telephone
facilities. Similar facilities shall also be available for private use by
patients.
(9) ( a ) In respect of operations listed under Part I of the
Second Schedule, the facilities and resources as well as
the condition or medical fitness of the patient shall be
such as to enable such operations to be carried out
under conditions of good surgical and medical
practice, as recommended by academic colleges of
anesthesiologists and of surgeons recognised by the
Superintendent.
( b ) No surgical operations as are listed or referred to in
6 _g S.L.458.23 LICENSING OF PRIVATE MEDICAL CLINICS
Part II of the Second Schedule may be carried out at a
clinic unless there are adequate operating theatre
facilities, as are specified in the Third Schedule, to the
satisfaction of the Superintendent.
( c ) Where in any clinic, surgical operations are undertaken
or a life support system is used, there shall be available
adequate facilities for immediate electrical supply in
case of interruption of the public supply as is needed to
safeguard the lives of the patients.
(10) In this regulation -
( a ) "to provide" includes, where applicable, to maintain;
and
( b ) where any question arises as to suitability,
acceptability or adequacy, it shall be deemed to be
suitable, acceptable or adequate, as the case may be, if
so considered in the opinion of the Superintendent.
Natal care. 10. Where antenatal, intranatal or postnatal care is given at a
clinic, the following provisions shall moreover apply:
(1) A registered midwife shall be in charge of all midwifery
services and may, in respect of midwifery services only, act as
person in charge for the purposes of regulation 5. In any case a
practising midwife shall be present on duty at all times maternity
care is provided.
(2) ( a ) The person in charge should make certain that
adequate general and specialist medical cover is
provided as needed.
( b ) Adequate arrangements shall exist for obtaining
obstetric, paediatric, anesthetic and any other
necessary help in an emergency situation.
( c ) Where epidural anesthesia is to be offered to women in
labour, this should be carried out by an anesthetist
trained in this procedure.
(3) ( a ) Where maternity beds are provided in a clinic they
shall be so designated and shall not, unless these are
single rooms, be used to accommodate any other type
of patient. Maternity patients shall not share rooms
with patients who are not in the clinic for obstetric
care.
( b ) No mentally disordered patient, alcoholic or drug
abuser may be accommodated in the section reserved
for maternity patients unless such patient requires
maternity care; in such case she shall be given separate
accommodation.
( c ) Adequate sanitary and bathroom facilities reserved for
the sole use of maternity patients shall be provided.
Grab rails and nurse call systems shall be included, and
where practicable showers and bidets.
( d ) Nursery accommodation shall be made available as
LICENSING OF PRIVATE MEDICAL CLINICS _g S.L.458.23 7
well as adequate facilities for the preparation as may
be necessary of infant formula or other breast milk
substitute.
( e ) Single rooms shall be present for maternity cases
which have special needs.
( f ) Delivery rooms shall be adequately sound-proofed.
( g ) Emergency electrical supplies shall extend to delivery
rooms, nurseries and to any operating theatre.
(4) ( a ) Resuscitation equipment for new-born babies shall be
provided.
( b ) When deliveries are being conducted, anesthetic and
suction machines shall be available.
( c ) Each infant shall have its own cradle of approved
design, thermometer and bath.
( d ) Each patient shall be provided with a comfortable
nursing chair.
(5) The licensee shall in addition to the records referred to
under regulation 11(1), keep a case record of each child born to a
patient in the clinic, which record shall include the following
particulars:
( a ) details of the weight and condition of child at birth; 
( b ) a daily statement of the child’s health;
( c ) details of each of any of the following paediatric
examinations, if carried out:
(i) examination for congenital abnormalities;
(ii) measurement of circumference of the head of the
child;
(iii) measurement of the length of the child;
(iv) screening for phenylketonuria or other screening
for congenital disorder.
(6) T'he following additional particulars shall be included on
the register of patients kept at the clinic in respect of maternity
patients:
( a ) the date and time of delivery of each patient, the
number of children born to the patient, their sex and
whether born alive or dead;
( b ) the estimated period of gestation prior to delivery;
( c ) the name and qualifications of the person who
delivered the patient;
( d ) the date and the time of any miscarriage occurring in
the clinic, including the period of gestation prior to
miscarriage;
( e ) the date on which any child born to a patient in the
clinic left the clinic; and
( f ) if any child born to a patient died in the clinic, the
date, time and cause of death.
8 _g S.L.458.23 LICENSING OF PRIVATE MEDICAL CLINICS
(7) The provisions of regulation 11(2), (3), (4) and (5) shall
mutatis mutandis  apply to these records.
(8) The provisions of this regulation and, as applicable, of the
other regulations, shall apply to any premises licensed as a
maternity home.
Registers, receipts, 
case records.
11. (1) Proper records are to be kept of patients treated at the
clinic -
( a ) in respect of each patient, in a register showing:
- the name, address, date of birth and identity card
number of the patient and, where the patient has
no identity card, the passport number shall be
included together with the country of issue, if
such patient has a passport;
- the name, address, identity card number and
telephone number of the patient’s next of kin or
of any person authorised to act on the patient’s
behalf;
- the name and address of the patient’s medical
practitioner;
- the date when and the time during which the
patient was admitted and the date of discharge or
transfer to a clinic or other place as may be
applicable;
- if the patient died in the clinic, the date, time and
cause of death;
- in the case of a child, where applicable, the
name and address of the school he attends or has
attended before being admitted to the clinic;
( b ) a separate register of all surgical operations performed
in the clinic: such register shall include in respect of
each operation, the date and time of such operation,
the patient’s name, the identity card or passport
number as may be applicable or as provided for under
the preceding paragraph, the clinic case history
number, the name of the medical or dental practitioner
who performed the operation, and, where applicable,
the name of any other practitioner assisting him, as
well as the name of the anesthetist in attendance;
( c ) a separate case record of every patient which shall
contain an adequate updated statement of the patient’s
health and condition and a note of any investigation
and details of surgical operations carried out and
treatment given, including the anaesthetic record
sheet.
( d ) a record of each member of the staff employed, which
record shall include the name, date of birth, identity
card number, grade and dates of employment at the
clinic, and, in respect of nursing staff, details of their
qualifications. Such records shall, as far as reasonably
practicable, include the times when individual
LICENSING OF PRIVATE MEDICAL CLINICS _g S.L.458.23 9
members of the nursing staff as well as the person or
persons in charge were on duty;
( e ) a record of the following:
- all fire practices;
- all fire alarm tests, results and action taken
where applicable;
- the maintenance carried out on medical, surgical
and nursing equipment in the clinic;
( f ) such other records as the Minister may, from time to
time, require to be kept.
(2) All records referred to in subregulation (1), other than
patient case records, shall be retained for a period of not less than
two years after the last entry made therein, and shall be open for
inspection by an authorised officer or by such authority as may
have such power under any law.
(3) Patient case records shall be retained and shall not be
destroyed except with the approval of the Minister.
(4) It shall be the duty of the person in charge of the clinic to
ensure proper keeping and storage of records and, subject to the
provisions of these regulations and to any other law relating to
confidentiality of records, to limit disclosure only to persons
entitled to access to such information.
(5) All records shall be legibly entered in full and in proper
order. Any alterations, corrections or deletions shall be initialled by
the person making such alteration, correction or deletion.
(6) Notwithstanding the provisions of the preceding sub-
regulations, computer records may, under such conditions as the
Minister may impose in the licence certificate, be acceptable,
provided always that a hard copy of the day’s entries are made each
day and filed in chronological order:
Provided that such alternative shall not, in the case where
the Minister directs that a copy of the entries be sent regularly to
the Ministry and/or the department, be construed as any acceptance
of any irregularity carried out at the clinic on the pretext that the
Ministry and/or the department had been regularly informed.
Work by 
government 
personnel.
12. (1) No medical practitioner, dental surgeon, nurse,
midwife, pharmacist, pharmacy technician or any other person to
whom Part V of the Act refers, and who is also in the employment
of Government, may, during those hours in which he is contracted
to provide his services to Government, work in any medical clinic
unless he is on approved leave of absence. Any breach of this
provision by any such medical practitioner, dental surgeon, nurse,
midwife, pharmacist, pharmacy technician or other person shall be
deemed to be an offence. It shall be the duty of the licensee of such
clinic to take all reasonable steps to ensure that this provision is
complied with.
(2) The licensee shall require all persons to whom Part V of the
Act refers to register their attendance at the medical clinic,
indicating date and time and whether entering or leaving the clinic,
10 _g S.L.458.23 LICENSING OF PRIVATE MEDICAL CLINICS
immediately on entering and immediately before leaving the clinic,
in a register kept for the purpose. The licensee shall transmit the
contents of such register to the Ministry or department in such
manner as may be specified by the Minister. The provisions of
regulation 11(6) shall also apply to the register referred to in this
provision.
(3) It shall be an offence for any licensee or person in charge of
a clinic to permit on the premises any person to whom
subregulation (1) refers unless the conditions of subregulation (2)
have been complied with.
(4) Where, except in an emergency, any licensee or person in
charge of a clinic is in wilful breach of any preceding provision of
this regulation, such clinic shall be deemed to have been operating
without a licence.
Inspections. 13. (1) Subject to the following provisions of this regulation,
any authorised person, on producing if asked to do so, a duly
authenticated document showing that he is so authorised, may enter
and inspect any premises which are used, or which he reasonably
believes to be used as a clinic and may require the production of
and may inspect any register or records maintained or retained in
pursuance of these regulations.
(2) Any authorised person may require the licensee or his
representative to furnish information in relation to the clinic in
respect of any matters mentioned in the First Schedule and such
other information as may reasonably be required for the purposes
of inspection:
Provided that nothing in this regulation shall be deemed to
authorise any person who is not a medical officer to inspect any
clinical record relating to a patient in the clinic.
(3) The licensee shall permit any authorised person to
interview in private any person in the clinic.
(4) The clinic shall be open for inspection by any authorised
person with a view to ensuring full compliance with the provisions
of these regulations.
(5) Every clinic licensed under these regulations shall be
inspected at least twice in every period of twelve months. The
inspecting officer or officers shall conduct a systematic review of
facilities and services with a view to ensuring compliance with
these regulations and with the conditions of the licence, and shall
submit a report to the Minister on the results of his inspection.
Staff members’ 
names.
14. The Ministry is to be informed of the names, addresses and
qualifications of each member of the staff employed on date of
issue, renewal or transfer of the licence and of any changes in staff
subsequent thereto.
Notice of death. 15. If a patient, or a child born to a patient dies in the clinic,
the licensee shall give notice to the Superintendent forthwith and
shall report to him in writing within twenty-four hours after such
death. Such notice shall include full particulars of the patient, the
circumstances and cause or suspected cause of death, and any other
LICENSING OF PRIVATE MEDICAL CLINICS _g S.L.458.23 11
information which may be relevant.
Receipt for 
services at the 
clinic.
16. For each service carried out on payment at the clinic, an
official itemised receipt shall be issued from the clinic to the
person in respect of whom such service was provided. The licensee
shall moreover ensure that a register of financial accounts of the
clinic is kept.
Serving.
any applicant or licensee from any requirement of the law
regarding any other licences which may be needed in respect of any
facility or service provided at the clinic.
12 _g S.L.458.23 LICENSING OF PRIVATE MEDICAL CLINICS
FIRST SCHEDULE
_gRegulation 4(2)_h
Matters in respect of which a health authority may require information to be 
furnished by an applicant for a licence
1. The full name and address, and professional or technical qualifications (if
any) of the applicant.
2. Where the application is made by a company, society, association or body,
the address of its registered office or principal place of business and the full names
and addresses and technical qualifications (if any) of the directors or partners.
3. The address of any other clinic in which the applicant has or had a business
interest and the nature and extent of his interest.
4. The situation of the clinic and its form of construction (plan to be attached).
5. The accommodation available, and the equipment and facilities provided or
to be provided in the clinic.
6. The date on which the clinic was established or is to be established.
7. Whether any other business is or will be carried on in the same premises as
the clinic.
8. The type of clinic services to be provided including list of operations
proposed to be carried out.
9. The number of patients (excluding staff) for whom it is proposed to be used
distinguishing between different categories of patients and indicating the age-range
of patients in each category.
10. The full names, ages, qualifications and experience of persons employed or
proposed to be employed in the management of the clinic.
11. The arrangements for the management and control of the clinic.
12. The full names and qualifications of any employed medical practitioners.
13. The full names and (where appropriate) qualifications and grades of the
nursing and other professional, technical, administrative and ancillary staff (other
than staff included under paragraph 12 above) employed or proposed to be employed
in the clinic.
14. The details of arrangements made or proposed to be made in respect of the
provision of facilities and services.
15. The arrangements made for the supply of blood and blood products.
16. The arrangements made for the provision of pathology and radiology
services.
17. The arrangements made for the insurance of patients, staff and third parties
against accidents and other mishaps.
18. Whether the clinic is intended to operate as a day care clinic only (i.e. with
no overnight stay) or as a clinic with overnight stay of patients.
LICENSING OF PRIVATE MEDICAL CLINICS _g S.L.458.23 13
The following operations may be carried out in a clinic, as referred to in sub-
regulation (9) of regulation 9, provided that the facilities and resources, as well as
the condition or medical fitness of the patient are such as to enable such operations
to be carried out under good medical, surgical and anesthetic practice in line with
guidelines established by international academic colleges of surgeons and
anesthesiologists recognised by the Superintendent.
Where day surgery is carried out this generally demands a high standard of
expertise, and should be undertaken only, or supervised, by experienced
practitioners. Such operations should be clean and elective surgical procedures and
should normally require a relatively short general anesthesia and should not carry the
risk of postoperative complications that normally require overnight stay in a clinic
and the patient is expected to recover sufficiently to return home in the early
evening. In particular haemostasis must be strictly ensured and where an operation
requires drainage, it may not always be suitable to be performed on a day care basis.
It is understood that the facilities should be similar to those required for in-patient
surgery with ward area near the operating theatre suite (including anesthetic room
and recovery room of the high dependency type) and, without prejudice to the
generality of this requirement, must have adequate lighting, basic equipment, piped
gases and gas scavenging devices. Basic equipment includes anesthetic machine and
monitoring apparatus, operating table, diathermy machine, dressing trolleys, scrub
facilities as well as other equipment required in accordance with good surgical and
anesthetic practice for specific operations.
The elderly and infants are normally excluded and the arrangements for post-
operative care outside the clinic must be satisfactory. In particular the patient must
have adult attendance and it must be ensured that such patient is in close reach of the
telephone for emergencies. After discharge from the clinic, the patient must be given
appropriate instructions following discharge and be accompanied home.
If the patient is deemed to be unfit for discharge from the clinic on the same day
either on anesthetic or surgical grounds, it shall be the responsibility of the person in
charge of the clinic to make appropriate arrangements for in-patient admission to a
clinic where overnight stay is allowed.
In every case the prudent exercise of clinical judgement by the surgeon and the
anesthetist, faced with an individual problem and particularly when faced with non-
ideal facilities, is mandatory.
A. Paediatric Surgical Operations
(i) General
Examination under anesthesia
Repair of inguinal/umbilical/femoral/epigastric hernia
Varicocele
Ligation of communicating hydrocele
Orchidopexy (unilateral or bilateral), excluding second stage operations
or cases of high non-palpable testis
Laparoscopy 
SECOND SCHEDULE Amended by:L.N. 183 of 2003.
_gRegulation 9(9)_h
Part I
14 _g S.L.458.23 LICENSING OF PRIVATE MEDICAL CLINICS
Circumcision, meatotomy
Minor hypospadias 
Cystoscopy
Division of tongue tie
Proctoscopy, sigmoidoscopy, anal stretch, examination under anesthesia
Excision of local skin lesions, including biopsy
Lymph node biopsy
Branchial sinus, thyroglossal cyst
Correction of prominent ears
Excision of accessory auricles and digits
Correction of syndactyly
Minor revision following cleft lip and palate surgery
Biopsy/excision/destruction of lesions, or removal of excess mucosa, of
mouth
Removal of calculi from salivary ducts
(ii) Orthopaedic
Arthroscopy 
Manipulations, closed reductions of simple fractures/dislocations
Change of plaster
Release of trigger finger 
Excision of ganglion
(iii) Dental
Extractions/conservation dentistry 
Supernumerary or impacted teeth 
Biopsy of oral lesions, including excision
Lingual or labial frenectomy
Removal of fixators
Enucleation of simple cysts
(iv) Ear, Nose and Throat
Examination under anesthesia and removal of foreign body from ear,
nose and throat
Myringotomy and insertion/removal of tympanostomy tube
Electro-cochleography
Reduction for fractured nose
Electro-cautery for bleeding of nose
Submucosal diathermy
Simple nasal polypectomy
Antral puncture and washout
(v) Ophthalmic
Correction of squint 
LICENSING OF PRIVATE MEDICAL CLINICS _g S.L.458.23 15
Electro-diagnostic tests
Examination under anesthesia for ophthalmic conditions
B. Adult Surgery 
(i) General
Excision of lesions of skin and subcutaneous tissue, including rodent
ulcer
Cautery/cryotherapy of skin
Removal of foreign body in deeper tissue
Dermabrasion
Skin suture
Insertion/removal of skin expander into tissue
Repair of simple inguinal, femoral, umbilical or epigastric hernia
Anal fissure, anal stretch, sphincterotomy
Excision of anal fistula
Removal of anal warts
Repair of anal trauma
Rectal polypectomy
Haemorrhoidectomy
Diagnostic Laparoscopy
Needle biopsy of liver
Oesophagoscopy and dilatation
Biopsy breast, lymph node, skin, lesions of mouth
Removal of salivary calculus
Ligation, stripping of/other operations for, varicose veins
Excision of thyroglossal cyst
Excision of bronchial sinus
Incision and drainage of abscess, drainage of haematoma
Microdochotomy
(ii) Orthopaedic
Note: Facilities for image intensification and application of plaster casts
where necessary should be available
Axthroscopic procedures, including biopsy and operation on articular
cartilage
Manipulation of joints, closed reduction of simple fractures/
dislocations
Removal of pins, plates or screws, external fixator
Excision of ganglia, synovial cysts and benign synoviomata
Decompression of carpal tunnel
Decompression of peripheral nerve
De Quervain’s release
Removal of neuroma, e.g. on the hand
16 _g S.L.458.23 LICENSING OF PRIVATE MEDICAL CLINICS
Correction of minor deformity of hand/foot
Minor amputation of the fingers and toes
Operation on ingrowing toe nails
Subcutaneous tenotomy
Tendon transposition
Primary repair of peripheral nerve
Ulnar styloidectomy
Excision of exostoses
Interphalangeal fusion of the toes
Hallus valgus and osteotomy of metatarsals
Release of trigger finger
Simple excision of palmar fascia in Dupuytren’s contracture
Removal of foreign bodies
Scar revision
Biopsy, excision of small lesion, limited repair, of muscle
(iii) Urinary System
Note: Uncatheterised patients should not be sent home before they have
passed urine.
Percutaneous nephrostomy fine needle biopsy of kidney
Nephroscopic operations on ureter
Ureteroscopic extraction of calculus of ureter
Endoscopic examination/insertion/removal of prosthesis, ureter
Endoscopic retrograde pyelography
Operations on ureteric orifice
Endoscopic destruction of lesion of bladder
Endoscopic hydrostatic distention of bladder
Endoscopic extraction of bladder calculus or foreign body
Endoscopic dilatation of, or operations on, outlet of female bladder
Repair of epispadias
Endoscopic operations on urethra
Endoscopic examination of urethra/removal of foreign body
Dilatation of urethra
Endoscopic biopsy of prostate
(iv) Genital System
External meatotomy of urethral orifice
Orchidectomy and excision of spermatic cord 
Orchidopexy
Correction of hydrocele
Excision of epididymal cyst, scrotal lesion
Biopsy testis
LICENSING OF PRIVATE MEDICAL CLINICS _g S.L.458.23 17
Operations on varicocoele
Division of preputial adhesions
Circumcision
Vasectomy
(v) Ophthalmic Operations
Cataract surgery
Corneal transplant surgery
Procedures on the eyelid or tarsal plate
Operations on the lachrymal apparatus
Correction of squint
Surgery for refraction
Laser surgery
Keratoplasty
Iridectomy
(vi) Ear, Nose and Throat
Endoscopy of nasal cavity, sinuses, pharynx, larynx, including biopsy
Removal of foreign body from the nose or ear canal
Removal of impacted wax
Excision of lesion of external ear
Myringotomy/insertion/removal of tympanostomy tube
Removal of simple nasal polyps
Reduction of fracture nasal or molar bone
Electro-cautery of the nasal septum
Submucosal diathermy of the inferior turbinates
Antral puncture and washout
Removal of vocal polyp
Diagnostic laryngoscopy, pharyngoscopy and oesophagoscopy
(vii) Endoscopic/Laparoscopic procedures of gastro intestinal tract
Oesophagoscopy/oesophagostro duodenoscopy, including biopsy/
removal/laser or diathermy destruction of lesion
Endoscopy and removal of foreign body/insertion of prosthesis/
dilatation/recanalisation of tumour mass
Sigmoidoscopy including biopsy/removal/destruction of lesion
Fibreoptic colonoscopy including excision/biopsy/destruction of lesion
Endoscopic retrograde cholangiopancreatography
(viii) Plastic Surgery
Excision of skin lesion: direct closure, split skin or full thickness graft,
local flaps (other than grafts to the lower limbs)
Scar revision and soft tissue contouring
Separation and inset of certain flaps
Debulking and revision of flaps
18 _g S.L.458.23 LICENSING OF PRIVATE MEDICAL CLINICS
Insertion and distension of tissue expanders
Operations for axillary hyperhidrosis
Laser and cryosurgery
Excision of tattoos
Blepharoplasty
Rhinoplasty
Mastopexy
Limited Liposuction
(ix) Gynaecologyical Operations
Note: Uncatheterised patients should not be sent home before they have
passed urine
Examination under anesthesia and curettage
Colposcopy, cystoscopy, diagnostic hysteroscopy/laparoscopy,
including biopsy and minor laparascopic surgery
Biopsy/cautery of cervix, removal of cervical polyp
Hormone implants
Excision of vulval warts and other minor procedures to the vulva and
vagina
Marsupialisation of Bartholin’s cyst
Endometrial ablation with laser or resectoscope
Hysteroscopic resection of uterine septum
Hysteroscopic myomectomy
Laser treatment of cervical and vulval lesions
Tubal ligation
Biopsy of ovary or peritoneum
Coagulation of mild endometriosis
Aspiration of small ovarian cysts
Lysis of mild to moderate adhesions
Coagulation of moderate endometriosis
Exploration of small ovarian cysts
Uterine ventrosuspension
Salpingectomy
Salpingectomy for ectopic pregnancy
(x) Oral and Maxillofacial Surgery
Excision of uncomplicated impacted teeth and buried roots
Exposure of unerupted teeth for orthodontic treatment
Biopsy of hard and soft tissues
Enucleation of small cysts of jaw
Division of pedicles
Removal of direct bone plates and wires
Minor soft-tissue surgery
LICENSING OF PRIVATE MEDICAL CLINICS _g S.L.458.23 19
EUA for suspected malignancy
Cryoblockade of peripheral nerves
Laser and cryosurgery of small lesions
Reduction of nasal and molar fractures
Temporomandlibular arthroscopy
Salivary ductoplasty and removal of calculi
(xi) Other
Bronchoscopy, including biopsy and/or remwal of foreign body
Oesophagoscopy and dilatation
Removal of pectus bar
Mediastinoscopy
Chest drainage
(xii) Interventional Radiology
CT Scan using contrast
Isotope scanning
Arteriography using small arterial catheters
(xiii) Pain Relief
Epidural injections - cervical, lumbar or thoracic
Peripheral nerve lesion - using injection, radiofrequency, cryoprobe or
phenol.
Part II
The following operations may be carried out in a clinic where patients are kept
overnight subject to the facilities referred to under regulation 9(9)( b ) being available
at the clinic:
1. All operations listed under Part I of this Schedule.
2. Any other surgical intervention other than -
Neonatal surgery
Intracranial operations
Major laryngeal surgery
Surgery for kyphosis and scoliosis
Cardiac surgery
Aortic surgery
Transthoracic oesophageal resection and other thoracic surgery excluding
lobectomy and simple chest drainage
Surgery for portal hypertension
Organ transplantation irrespective of whether the organ is obtained from a
cadaver or from a live donor
Any other operation or procedure, including any operation referred to in
Part I of this Schedule where there is a probability of the patient requiring
intensive care after surgery or where significant amounts of blood loss are
anticipated, if intensive care facilities, to the satisfaction of the
20 _g S.L.458.23 LICENSING OF PRIVATE MEDICAL CLINICS
Superintendent, are not available;
unless such operations are specifically approved by the Minister and a note to this
effect is entered in the licence.
_gRegulation 9(9)_h
Operating Theatre facilities 
(1) Facilities must include:
( a ) two operating tables;
( b ) a separate anesthetic room for each theatre;
( c ) a recovery room or area;
( d ) a cleansing room;
( e ) a sterilising room, including facilities for sterilising equipment which
cannot be autoclaved;
( f ) a plant room or area which may or may not be integrated with the
remainder of the suite;
( g ) storage space;
( h ) a rest/refreshments room;
( i ) toilets, wash basins and showers;
( j ) barrier zone;
( k ) a theatre control office;
( l ) facilities for infra-operative radiography including on the spot
development of X-Ray films.
(2) The floor area of the operating theatres shall be of an area not less than 37
square metres, and that of the anesthetic rooms of an area not less than 16.5 square
metres.
(3) The ceilings, floors and applied wall finishes of the operating suite shall be
smooth, impervious and jointless. The floor of the operating theatre shall be
similarly covered with material and have appropriate antistatic properties. All
finishes shall be able to withstand daily cleansing with water and disinfectants.
(4) (i) The operating suite shall be mechanically ventilated by a satisfactory
system which shall be capable of providing and maintaining:
( a ) temperatures (user adjustable) within a range of 15°C and 25°C;
( b ) relative humidity of the atmosphere within the range 40%-60%.
Only steam injection type humidifiers are permissible;
( c ) sufficient fresh air for the requisite temperature and humidity
control, dilution of airborne bacterial contamination and control
of air movements between clean and less clean areas.
(ii) For the purposes of the above provisions, "satisfactory system" means a
system acceptable by the international standards recognised by the
Superintendent.
Amended by:
L.N. 200 of 1996. THIRD SCHEDULE 
LICENSING OF PRIVATE MEDICAL CLINICS _g S.L.458.23 21
(iii) An approved system should be included for the removal of exhaust
anesthetic gases in accordance with specifications "BS 6834: 1987
Active Anesthetic Gas Scavenging Systems" or equivalent
specifications.
(5) (i) The operating theatre shall have clinical quality lighting capable of
rendering not less than 400 lux (excluding the illumination from
operating lamp). The preparation, scrubbing and recovery areas shall
have lighting of not less than 250 lux while the anesthetic areas should
have an illumination of not less than 300 lux. The remaining parts of the
suite should have an illumination of not less than 200 lux.
(ii) Essential lighting and power shall be provided in the theatre suite. These
shall be fed from an automatic standby power source which shall assume
the load after a period of not more than 10 seconds.
(iii) Emergency lighting fed from a D.C. Source shall also be available for
the essential parts of the operating theatre suite. There shall be ensured a
no break supply to the operating theatre lamps.
(6) Clinics carrying out surgery or admitting acutely ill medical patients shall
require a cardiac monitor, a pulse oximeter, a defibrillator, a fully equipped
resuscitation trolley and oxygen and suctions in all areas where acutely ill patients
may be kept. More than one set of equipment may be required in hospitals handling
large numbers of patients.
(7) Qualified and fully trained staff able to react and operate the cardiac
emergency equipment, if so required, have to be on duty 24 hours a day.
