Certified facility
Find out more about the requirements for a certified facility.
Last updated 12 December 2025
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General
Certified facility, generally refers to high containment (BSL3) or maximum containment (BSL4) facility that is certified in accordance with Section 51 of the Biological Agents and Toxins Act. A certified facility is a pre-requisite for the possession and handling of First Schedule Part 1, First Schedule Part 2, and Second Schedule biological agents.
Certification process is done by an independent facility certifying body approved and registered with the Ministry of Health (MOH), whose certification criteria is based on the reference materials approved by MOH.
The MOH-Approved Facility Certifying Body (MOH-AFCB) comprise certifiers who are approved by the MOH to have the necessary experience and are credible in certifying biocontainment facilities.
Requirements for registration as a certified facility
The facility must be certified by the MOH-AFCB.
The facility must have a Biosafety Committee composed of the members stipulated in the Sixth Schedule of the Biological Agents and Toxins Act (BATA).
All members of the facility shall comply with the duties and responsibilities stipulated in Part 5 of the BATA.
Additional requirements for facilities planning to handle First Schedule Part 2 biological agent, Second Schedule biological agent and/or Fifth Schedule toxin include:
the facility must be gazetted as a protected place under the Infrastructure Protection Act and meet the requirements stipulated in the Physical Security Workgroup checklist.
personnel working in the facility must be security vetted by the relevant authority
Certification requirements
The facility must engage the services of an MOH-AFCB to certify their facility and inform MOH of the certification schedule, 1 to 1.5 month prior to the certification date.
The following reference materials set the minimum criteria for facility certification:
High Containment (BSL3) Certification Checklist and/or the Singapore Standard: Specification for high containment (BSL3) facility, is to be used for the certification of high containment (BSL3) facilities.
National Biosafety Standard for Maximum Containment (BSL4) Facility [PDF, 372 KB] is to be used for the certification of maximum containment (BSL4) facilities.
Facilities must register with MOH if they intend to possess, store or work with First Schedule Part 1, First Schedule Part 2, and Second Schedule biological agents or with biological agents that are not in the 'List of Biological Agents and Toxins' but are evaluated by the MOH to be similarly classified as the above mentioned schedules.
Information and/or documents needed for registration as a certified facility
Please refer to FAQ – Certified Facility.
Register as a certified facility
Submit your application via the HALP-Biosafety portal.
Fees
Currently, the MOH does not charge any fees for the registration of a biomanufacturing facility.
However, compliance verification services (e.g. facility inspection or audit) provided by third party certifiers, inspectors or auditors (e.g. MOH-AFCB) will be chargeable.
Processing time
The processing time will depend on the accuracy and completeness of the information and supporting documents submitted for the application.
An application will be approved within 7 working days from successful certification provided that all the criteria and/or requirements for the application have been satisfied.
Validity of registration for certified facility
The validity of the registration of a certified facility with the MOH is tied with the validity of the facility certification indicated by the MOH-AFCB. The MOH may at its discretion, revoke or suspend the registration at any time.
The validity of the certification for a certified facility is 1 year except in cases wherein the facility certifier may issue a temporary certificate with a shorter validity period, either due to non-compliance in the requirements or a problem that requires the facility operator to rectify within a specified period.
The temporary certificate is issued on the condition that the identified issues will not compromise the safe and secure functioning of the facility. The issuance of a temporary certificate is subject to MOH's approval.
The facility shall consult the MOH and the MOH-AFCB who certified the facility prior to any design or structural change to the facility as these activities may affect the validity of the facility certification.
FAQ
Find answers to commonly asked questions on the FAQ page