LICENSING OF PRIVATE MEDICAL DIAGNOSTIC 
LABORATORIES g S.L.458.25 1
SUBSIDIARY LEGISLATION 458.25
LICENSING OF PRIVATE MEDICAL DIAGNOSTIC 
LABORATORIES 
9th July, 1996
LEGAL NOTICE 133 of 1996.
Title.
Medical Diagnostic Laboratories Regulations.
Interpretation.
requires-
Cap. 464.
"authorised person" means a person authorised by the Minister to
act on his behalf;
"good laboratory practice" includes the compliance at all times
with the ethical standards and with laws and regulations governing
the professions related with laboratory practice, as well as
compliance with international standards for procedures, practices
and methods used in a laboratory;
"laboratory" means a private medical diagnostic laboratory, and
includes any facility, building or otherwise, used for the purpose of
biological, microbiological, serological, chemical,
immunohaematological, haematological, biophysical, cytological,
pathological, or other examination of material derived from the
human or animal body, or for the purpose of providing information
for the diagnosis, prevention or treatment of any disease, condition
or impairment of health, or for the assessment of the state of health
of a person or animal, but does not include a government
laboratory;
"Minister" means the Minister responsible for health.
Laboratory to 
comply with these 
regulations.
Cap. 31.
3. (1) No licence for operating a laboratory under article 98
of the Medical and Kindred Professions Ordinance may be granted
or renewed unless such laboratory complies with the provisions of
these regulations.
(2) No licence under the said article 98 of the Medical and
Kindred Professions Ordinance may be issued for any laboratory
except in respect of a premises used for medical laboratory tests
and procedures.
Application for a 
licence.
4. (1) An application for the issue or renewal of a licence for
a laboratory shall be made to the Minister in writing:
Provided that an application has been filed before the date
of these regulations, it shall be considered to have been filed
according to these regulations.
(2) On making an application under subregulation (1), the
applicant shall present together with the application the
information specified hereunder:
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LICENSING OF PRIVATE MEDICAL DIAGNOSTIC 
LABORATORIES
( a ) a comprehensive list of all the tests and other activities
carried out or intended to be carried out at such
laboratory;
( b ) a list of all the staff that are employed or to be
employed at the laboratory, including their name and
surname, identity card number, permanent address,
date of birth, date of employment, academic
qualifications and duties and responsibilities each
employee shall have;
( c ) a list of equipment that is used, or intended to be used
on the premises;
( d ) a list of animals that are kept or used, or intended to be
kept or used for such tests; 
( e ) the policy and procedures for quality control and
safety:
Provided that the Minister or any authorised person may
request of the applicant any additional information and more
specific information that is deemed to be related with the granting
of the licence.
Refusal of licence. 5. (1) The Minister may refuse to issue or renew a licence in
respect of a laboratory if -
( a ) the applicant, or any person employed or proposed to
be employed by the applicant at the laboratory, is not
of good conduct or that the technical staff is not
suitably qualified; or
( b ) for reasons connected with the situation, construction,
state of repair, safety, accommodation, staffing or
equipment, the premises are not fit to be used as a
laboratory; or
( c ) the laboratory or any premises in connection therewith
are used or proposed to be used for purposes which are
not related to the laboratory, or are in any way
improper, unethical or not lawful; or
Cap. 356.
( d ) the laboratory or any premises used in connection
therewith consist of or include works executed in
contravention of the provisions of the Development
Planning Act; or
( e ) the practice at the laboratory is not, or will not be,
under the supervision of a person indicated in
regulation 6; or
( f ) the management and control of the laboratory is not
likely to be adequate.
S.L. 458.23
(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 the Tribunal appointed under
regulation 5(2) of the Licensing of Private Medical Clinics
Regulations.
LICENSING OF PRIVATE MEDICAL DIAGNOSTIC 
LABORATORIES g S.L.458.25 3
Professional 
direction, 
supervision and 
responsibility for 
tests.
6. Every licensee shall ensure that medical laboratory tests
are carried out by, or under the professional direction, supervision
and responsibility of, a biochemist, microbiologist or other
pathologist, or a toxicologist, as the case may be, or a medical
practitioner or scientist qualified to assume professional, scientific,
consultative, organisational and administrative responsibility for
the service.
Category and types 
of tests.
7. (1) The licence certificate shall specify the category and
types of tests that may be carried out at the premises as may be
determined by the Minister to be reasonable in accordance with
good laboratory practice taking into account the size of the
laboratory and the facilities available.
(2) The licensee shall ensure that no tests other than those
referred to in subregulation (1) shall be carried out at the laboratory
unless and until such test has been approved by the Minister.
Registers and 
records.
8. (1) The licensee shall keep and maintain an updated
register in connection with all tests carried out at the laboratory,
which register shall, in respect of each patient, include the
following information:
( a ) the name and surname, (or initials), identity card
number, sex, address and date of birth of the patient;
( b ) the name, surname, address and medical registration
number of the referring medical practitioner;
( c ) the date when the request was received at the
laboratory;
( d ) the type of test requested by the referring medical
practitioner;
( e ) the type of test carried out at the laboratory and
methods used;
( f ) the name of the microbiologist, biochemist or other
pathologist, or toxicologist responsible for the test, as
well as the technical person who carried out the test;
( g ) where practicable, the result of the test:
Provided that the requirements in respect of the identity of
the patient shall not apply when the blood of a patient is taken for
testing for the human immunodeficiency virus, so that this test is
carried out in a government laboratory.
(2) The licensee shall also keep records of reports of all results
of tests carried out at his laboratory.
(3) ( a ) The licensee shall require all persons to whom Part II
and Part V of the Act refers, to register their
attendance at the laboratory, indicating date and time
and whether entering or leaving the laboratory,
immediately on entering and immediately before
leaving the laboratory, 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 specified by the Minister.
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LABORATORIES
( b ) Where, except in an emergency, a licensee is in wilful
breach of the preceding provision of this regulation,
such laboratory shall be deemed to be operating
without a licence.
(4) The Minister may from time to time prescribe that
additional registers be kept as may be deemed necessary to ensure
good laboratory practice.
Maintenance and 
inspection of 
registers and 
records.
9. All information entered in the registers referred to in
regulation 8, as well as all records, shall be retained by the licensee
for a period of not less than two years from the date of the last entry
in the register or record:
Provided that in respect of histological tests or any forensic
or toxicological tests, the result shall be kept for a period of
twenty-five years:
Provided further that results of tests of quality assessment
or maintenance shall be kept indefinitely.
Licensee to notify 
certain diseases.
Cap. 36.
10. The licensee shall inform forthwith the Superintendent of
Public Health of any infectious disease diagnosed at the laboratory,
notifiable under the Prevention of Disease Ordinance, as well as of
all pathological samples confirmed for malignancy, with the details
of name, address and identity card number of the patient, as well as
the name, address and medical registration number of the referring
medical practitioner.
Provision of 
facilities and 
services.
11. (1) The licensee shall ensure that there is sufficient space,
equipment and facilities for the proper performance, within the
medical laboratory, of the required volume of work to ensure that a
high standard of accuracy, precision, efficiency and safety is
always maintained to the satisfaction of the Minister.
(2) Without prejudice to the generality of subregulation (1), the
licensee, having regard to the category of tests performed at the
laboratory, shall -
( a ) provide adequate professional, technical, ancillary and
other supporting staff; 
( b ) provide and maintain adequate laboratory facilities in
accordance with good laboratory practice;
( c ) maintain all parts of the building in a good structural
state of repair, and, in particular, provide adequate
lighting and ventilation, and all necessary safety;
( d ) maintain a high degree of cleanliness and hygiene in
all parts of the building;
( e ) take established precautions against the risk of fire and
make established arrangements for detecting,
containing and extinguishing fires and for the
evacuation of staff in the event of such fire. In
particular the licensee shall comply with such
instructions as may be given by the Commissioner of
Police in this respect;
LICENSING OF PRIVATE MEDICAL DIAGNOSTIC 
LABORATORIES g S.L.458.25 5
( f ) make appropriate arrangements to the satisfaction of
the authorised person for the disposal and incineration
of infected swabs and sharps besides other infected
material and provide adequate containers for them;
( g ) take all the necessary precautions to ensure the safety,
both physical and biological, of all staff on the
premises. Moreover, he shall provide and maintain
adequate means of protection against occupational
hazards, and ensure that all staff is making use of the
protection provided.
(3) The licensee shall make available, when so required by the
Minister or by any authorised officer, the following written codes
of practice and procedures:
( a ) the laboratory’s policy for quality control on a daily
basis, including accreditation of its tests from an
authority that is recognised by the Minister to be
appropriate and reliable, with inter-laboratory
calibration exercises forming part of this accreditation;
( b ) the laboratory’s policy on instrument function checks
and preventive maintenance of instruments;
( c ) the laboratory’s safety policies to the workers, the
patients and the public in general:
Provided that the Minister may from time to time require
these codes to be amended and updated as he may deem
appropriate.
(4) The licensee shall ensure that the codes referred to in
subregulation (3) are strictly adhered to by all persons working in
the laboratory.
Power of 
inspection.
12. It shall be lawful for any authorised person, to enter at any
time of day and night without prior notice, and inspect any
premises which are used or suspected to be used with or without a
licence as a medical laboratory, and such person shall be given by
the person in charge at the time, all assistance requested or implied.
The said person in charge shall produce all registers and records
available at that time when asked to do so:
Provided that where the information requested entails
medical confirmation regarding the patients, such information may
only be requested by and made available to an authorised person
who is a medical practitioner.
Safety and 
prevention of 
danger.
13. The licensee shall ensure that all measures be taken to
protect the staff and the neighbourhood from any nuisance or
danger arising from the activities of the laboratory.
Non-applicability 
of regulations.
14. These regulations do not apply to the medical tests carried
out by the use of medical diagnostic kits intended for home use,
irrespective of where these tests are carried out, or in respect of
tests carried out by a medical practitioner in his consulting room or
at the patient’s home, or bedside, using doctor’s office equipment
in the exercise of his profession.
