Setting Up A Laboratory In Singapore For Genetic And DNA Testing – Regulatory Requirements

Genetic and DNA testing is becoming increasingly prevalent worldwide, including in Singapore. Advances in technology and a growing interest in genetic and DNA testing for preventive health have driven this trend. For instance, in recent years, we have been multi-cancer DNA detection products like LucenceINSIGHT and SPOT-MAS, as well as generic testing kits like CircleDNA. What are the main regulatory requirements for the setting up a laboratory in Singapore for genetic and DNA testing?

Regulatory Requirements

To set up a laboratory in Singapore for genetic testing, several registrations and licenses must be obtained. The laboratory must comply with the Healthcare Services Act (HCSA), which requires a Clinical Laboratory Service license if the laboratory performs any of the following services:

According to MOH, you will require a Clinical Laboratory Service licence if you perform any of the following purposes:

• Assessing the health or genetic predisposition of that individual or any other individual;
• Predicting or providing a prognosis of the health condition of that individual or any other individual;
• Diagnosing any condition, disability, disease, disorder or injury of that individual or any other individual;
• Determining the intervention to be taken, or the effect of any intervention taken, of any condition, disability, disease, disorder or injury of an individual;
• Assessing the health, condition or suitability of any human biological material that is used, or is intended to be used, in relation to any healthcare services.6.   Ascertaining the result of a medical or surgical treatment given so that individual or any other individual.

Additionally, the laboratory should eventually be SAC-accredited according to the technical and management system standards of ISO/IEC 17025 – General Requirements for the Competence of testing and calibration laboratories – and ISO 15189 – Particular Requirements for Quality and Competence (for medical laboratories only).

Real Estate For Laboratories In Singapore

Finding suitable real estate for a genetic testing laboratory in Singapore involves considering locations such as Biopolis, Singapore Science Park, Tuas Biomedical Park, and Kallang. These areas are strategically located and offer the necessary infrastructure for life sciences research and development6. Companies like CapitaLand and JLL provide real estate solutions tailored to the needs of life sciences organisations.

Key Executives

Key executives that need to be appointed include a Clinical Governance Officer to ensure compliance with regulatory standards and a Laboratory Manager to oversee daily operations. In brief, a Clinic Governance Officer must:

• Reside in Singapore during his or her appointment as a CGO
• Be a fully registered medical practitioner with the Singapore Medical Council (SMC) and hold a valid practising certificate
• Be registered as a specialist in pathology or haematology with the following qualifications:
  • A pass in the Fellowship of the Royal College of Pathology Part 1 and Part 2 examinations or other equivalent exit examinations from a professional board approved by the Director-General; and
  • At least 5 years of work experience in a clinical laboratory licensed under the Private Hospitals and Medical Clinics Act 1980 or in the provision of a Clinical Laboratory Service licensed under this Act, or another equivalent clinical laboratory outside of Singapore approved by the Director-General.

Additionally, it is essential to have qualified Medical Laboratory Technologists and Genetic Counselors to perform and interpret genetic tests accurately.

Contact Us

If you are considering setting up a laboratory in Singapore to offer healthcare services to the public or to clinics / doctors, we would be pleased to explore potential collaboration. Contact us via the button below.

Additional Resources On MOH Licensing Requirements For Setting Up A Laboratory In Singapore

Learn More: How to apply for a licence from MOH >>

Learn More: MOH Licensing eGuides >>

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