Companies dealing in only minimally manipulated CTGTP (e.g. all Class 1 CTGTP) are not subject to licensing requirements. However, these companies will need to notify HSA prior to the start of their manufacturing, importing or wholesaling activity.
Upon successful submission of a notice, the dealer will be considered a known importer, known wholesaler or known manufacturer. Known dealers are required to comply with the respective duties and obligation as stated under the CTGTP regulations such as duties to:
- maintain records of manufacture
- maintain records of receipt and supply
- maintain system of traceability of the CTGTP and its starting and raw materials, including any substances that come into contact with the cells and tissue
- maintain records of defects and adverse effects
- report defects and adverse effects
- notify the Authority concerning recall, and
- notify the Authority before supply of Class 1 CTGTP
Failure to submit a notice is an offence under the CTGTP Regulations.
Companies dealing in a minimally manipulated CTGTP which is intended for clinical use are required to comply with the quality system standards as follows:
For importers and wholesalers:-
- GDP-MDS: Singapore Standard for Good Distribution Practice for Medical Devices (SS 620)
- ISO 13485: Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes (2016 edition) or
- GDP: HSA Guidance Notes on Good Distribution Practice
Renewal of the notice is not required. However, the company must submit an update of the dealer’s notice whenever there are any changes to the information (including cessation of business) which was provided earlier in the notice, within 14 days of the change.
Fees and turn-around-time
Refer to CTGTP fees and turn-around-time for more information.
How to apply
Submit your application through the relevant application form. Ensure you have the following before submitting your application: