Singapore legislation

Regulation 62

of Healthcare Services (Assisted Reproduction Service) Regulations 2023

Regulation 62

Keeping of records

Subregulation 1

A licensee must —

(a)

maintain proper, complete and accurate records of every programme, policy, system, measure, protocol or process that the licensee is required to implement under these Regulations, and every activity undertaken under or change made to that programme, policy, system, measure, protocol or process;

(b)

maintain records of every approval given by a Clinical Governance Officer under these Regulations; and

(c)

maintain records of every policy and procedure established by a Clinical Governance Officer under these Regulations.

Subregulation 2

Without limiting paragraph (1), the licensee must —

(a)

establish and implement a process to ensure there is proper document control of all documents relating to the assisted reproduction service;

(b)

ensure that a Clinical Governance Officer approves, signs and dates each record mentioned in paragraph (1)(a); and

(c)

ensure that at least one personnel is responsible for the document control of all documents relating to the assisted reproduction service.

Subregulation 3

The licensee must ensure that each record mentioned in paragraph (1)(a) is available for reference at all times to each personnel.