Certified Facility
Find out more about the requirements for a Certified Facility.
General
Certified Facilities refer to High Containment (BSL3) or Maximum Containment (BSL4) facilities certified under Section 51 of the Biological Agents and Toxins Act (opens in new tab) (BATA). Certification is a prerequisite for possessing and handling First and Second Schedule biological agents. Certification is conducted by Health Sciences Authority-Approved Facility Certification Body (HSA-AFCB), which meets HSA-approved criteria.
Requirements
The facility:
Must have a Biosafety Committee comprises members as per the Sixth Schedule of the BATA.
Must implement safety and security measures aligned with the -
Singapore Standard (SS696:2023) Specification for High Containment (BSL3) Facility (opens in new tab) if First Schedule biological agents are handled; or
Biosafety Standard for Maximum Containment (Biosafety Level 4) Facility (opens in new tab) if Second Schedule biological agents are handled.
Must be gazetted as Protected Place under the Infrastructure Protection Act (opens in new tab) and comply with the Protective Security Working Group Guidelines (opens in new tab) if First Schedule Part 2 or Second Schedule biological agents, or Fifth Schedule toxins are handled.
Has been successfully certified by an HSA-AFCB.
All members of the facility must adhere to their duties and responsibilities stipulated in Part 5 of the BATA and be security vetted if First Schedule Part 2 or Second Schedule biological agents, or Fifth Schedule toxins are handled in the facility.
Application
Facilities meeting the above requirements can apply to register as a Certified Facility via the Healthcare Application and Licensing Portal-Biosafety Module (HALP-BS (opens in new tab)).
For more details, visit the FAQ – Certified Facility page.
Fees
Currently, HSA does not charge fees for registration of a Certified Facility, but facility certification/audit services provided by third party certification body (i.e. HSA-AFCB) are chargeable.
Processing Time
Processing time depends on the accuracy and completeness of the submission. Application may take up to 30 working days, only if all the requirements are met.
Validity
Registration validity is tied to the certificate or equivalent document issued by the HSA-AFCB and is typically one year. Any design or structural change to the facility may also invalidate the registration and HSA may revoke or suspend the registration at its discretion. Consult HSA and HSA-AFCB before any facility modifications.
Frequently Asked Questions
Find answers to common queries on the FAQ page
