PART 2
APPROVED TEST PROVIDERS
Only approved test providers may provide regulated activity
4.—(1)  A person commits an offence if the person —
(a)intentionally provides, or intentionally causes or allows to be provided, in the course of business at any premises in Singapore; or
(b)intentionally holds out, or intentionally causes or allows to be held out, as providing in the course of business at any premises in Singapore,
a service involving the carrying on of any regulated activity for hire or reward when the person is not approved and not treated as approved under these Regulations by the Director to provide that service and knowing that the person is not so approved or treated as approved.
(2)  A person commits an offence if the person —
(a)intentionally provides, or intentionally causes or allows to be provided, in the course of business at any premises in Singapore; or
(b)intentionally holds out, or intentionally causes or allows to be held out, as providing in the course of business at any premises in Singapore,
a service involving the carrying on of any regulated activity for hire or reward when those premises are not specified and not treated as specified under regulation 6(1) or (3) in that person’s approval and knowing that those premises are not so specified or treated as specified.
(3)  A person who is guilty of an offence under paragraph (1) or (2) shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 6 months or to both.
Application to be test provider
5.—(1)  An application —
(a)for approval under these Regulations as a test provider; or
(b)for premises to be specified in an approval under these Regulations,
must be made to the Director in accordance with this regulation.
(2)  An application under paragraph (1) for approval or for additional premises to be specified in an approval must —
(a)be in the form and manner the Director specifies;
(b)state each premises at which the applicant intends to provide a service involving the carrying on of the regulated activity to which the application relates;
(c)contain a description of the service involving the carrying on of the regulated activity to which the application relates and how the regulated activity will be carried on in each of the premises stated under sub‑paragraph (b);
(d)state each approved test to be used in providing the service and the fees to be charged by the applicant for each test;
(e)describe the administrative procedures for maintaining records of the regulated activity in the application to be carried out by the applicant;
(f)state whether the applicant is also using those premises as a private hospital, medical clinic or clinical laboratory under the authority and in accordance with the terms and conditions of a PHMCA licence;
(g)state whether the applicant is an occupier of the premises stated under sub‑paragraph (b);
(h)in relation to each premises that are stated under sub‑paragraph (b) and are not the subject of a PHMCA licence —
(i)be accompanied by a risk assessment conducted and endorsed by a qualified person employed or engaged by the applicant, in relation to the safety and health risks posed to any individual who may be affected by the carrying on of the regulated activity in the application, such as but not limited to the crowd management of individuals seeking to undergo or carry out approved tests and the handling of potentially biohazardous material; and
(ii)specify the processes, policies and protocols planned so as to eliminate any foreseeable risk to any such individual;
(i)contain an address in Singapore at which notices and other documents under these Regulations for the applicant may be served;
(j)be accompanied by any information that the Director requires to decide on the particular application; and
(k)be accompanied by a non‑refundable fee of $385.
(3)  Upon receiving an application under paragraph (1), the Director may carry out, or arrange to be carried out, such investigations and inquiries in relation to the application as the Director considers necessary for a proper consideration of the application, which may include an inspection of either or both the following:
(a)the premises stated under paragraph (2)(b) as where the applicant intends to provide a service involving the carrying on of any regulated activity to be authorised by the approval;
(b)any vehicle, equipment or other thing which the applicant intends to use to provide a service involving the carrying on of the regulated activity to be authorised by the approval.
(4)  The Director may refuse an application under paragraph (1) —
(a)that is incomplete or not made in accordance with this regulation; or
(b)where an inspection mentioned in paragraph (3) in relation to the application is refused.
(5)  The Director may, in any particular case, waive in whole or part the payment of the application fee specified in paragraph (2)(k).
Applications treated as approved
6.—(1)  In the case of a person’s application for approval or for additional premises to be specified in an approval, the person is, upon the Director receiving the application, treated as approved under these Regulations to provide in the course of business a service involving the carrying on of the regulated activity at the premises specified in the application or those additional premises are treated as specified in the person’s approval (as the case may be) if —
(a)the person holds a PHMCA licence;
(b)those premises are the subject of the PHMCA licence; and
(c)the person states in the person’s application under regulation 5(2)(b), those premises as where the person intends to provide a service involving the carrying on of the regulated activity to which the application relates.
(2)  An application —
(a)for approval, other than an application which may be treated as approved under paragraph (1); or
(b)for additional premises to be specified in an approval, being premises not subject to a PHMCA licence,
must be made at least 5 working days before the date the person intends to start providing in the course of business, at the premises stated in the application, a service involving the carrying on of the regulated activity to which the application relates.
(3)  In the case of a person’s application mentioned in paragraph (2), the person is treated as approved under these Regulations to provide in the course of business a service involving the carrying on of the regulated activity at the premises specified in the application or those additional premises are treated as specified in the person’s approval (as the case may be) on the 5th working day after the application is received by the Director unless the Director —
(a)earlier approves the application; or
(b)earlier refuses the application under regulation 7.
Grounds for refusal
7.—(1)  For the purpose of determining whether or not a person should be approved or refused approval, or refused specifying any additional premises in an approval, the Director must have regard, and give such weight as the Director considers appropriate, to all of the following matters:
(a)the adequacy of the premises, vehicle, equipment or other thing proposed to be used in providing the service involving the carrying on of the regulated activity in the application;
(b)the adequacy of the risk assessment and processes, policies and protocols mentioned in regulation 5(2)(h);
(c)whether the applicant and, where necessary, whether every responsible executive of the applicant is a suitable person to be involved in providing the service involving the carrying on of the regulated activity in the application;
(d)whether the applicant has an approval specifying any other premises not mentioned in the application;
(e)the demand for the service in the application;
(f)whether the applicant holds a PHMCA licence in respect of any premises;
(g)the qualifications and training of the individuals the applicant employs or contracts or intends to employ or contract to carry out the regulated activity involved in the service;
(h)the applicant’s ability to provide the service in a manner that conforms to the requirements of these Regulations and is clinically and ethically appropriate;
(i)whether approving the applicant advances the purpose of preventing, protecting against, delaying or otherwise controlling the incidence or transmission of COVID‑19 in Singapore.
(2)  For the purpose of determining whether or not a person or a responsible executive of the person is a suitable person to be involved in providing the service involving the carrying on of a regulated activity in the application, the Director must have regard, and give such weight as the Director considers appropriate, to all of the following matters:
(a)the person’s or individual’s relevant knowledge, competency and experience in matters connected with the regulated activity in the application;
(b)whether the applicant does or does not have (or is likely or unlikely to have) the financial capacity and ability to provide the service involving the carrying on of the regulated activity in the application according to the provisions of these Regulations.
(3)  To avoid doubt, the Director is not confined to consideration of the matters specified in paragraph (1) or (2) and may take into account such other matters and evidence as may be relevant.
Validity period of test provider approval
8.—(1)  Every approval is valid for 2 years unless one of the following first occurs:
(a)for a Class A test provider only, the test provider ceases to hold any PHMCA licence;
(b)the approval is revoked under Part 4;
(c)a notice to stop given in accordance with paragraph (2) takes effect.
(2)  An approved test provider who intends to wholly stop providing, in the course of business, a service involving the carrying on of any regulated activity for hire or reward, must give a notice to stop containing the date of stoppage to the Director, at least 5 working days before ceasing to provide the service; and that notice to stop takes effect on —
(a)the 5th working day after the Director receives that notice; or
(b)the date of stoppage stated, if that is later.
Conditions of approval for non-PHMCA licence premises
9.  The Director may, when approving an application in regulation 6(2) before the 5th working day after the application is received, impose conditions —
(a)fixing the place within those premises that are the subject of the application within which the regulated activity authorised by the approval may be carried out; and
(b)relating to measures to be taken by the approved test provider to mitigate or eliminate risks identified in the risk assessment mentioned in regulation 7(1)(b).