New/update notification
New/update notification
Currently, Class 1 CTGTP are excepted from product registration.
However, suppliers of Class 1 CTGTP must submit a product notification and receive HSA's written acceptance of the notification before supplying the product in Singapore.
Similarly, any changes to a Notified Class 1 CTGTP need to be notified with HSA:
- For changes to the tissue procurement sites and manufacturers of the Class 1 CTGTP, submit a new Class 1 CTGTP notification.
- For other administrative changes like changes in accreditation status of the tissue procurement sites and manufacturers (such as changes to AABB, AATB, EBAA, FACT, CAP certificates or tissue bank licence with new expiry date following re-audit), product label and shelf-life, submit an update notification within 14 days of the change.
The supplier is also responsible to ensure:
- the product was sourced from an accredited/licensed facility and that it is free from infectious agents
- all information provided in the Class 1 CTGTP notification is accurate and up to date
- compliance with the duties and obligations of dealing in a Class 1 CTGTP
Documents required
Refer to Documentary Requirements for Class 1 CTGTP Notification and Updates to ensure the submission of a complete dataset for product notification.
Fees and turnaround time
Refer to CTGTP fees and turnaround time for more information.