Regulatory information
Registrations for AmGraft® in Singapore and Indonesia, the product documents, and how to report an adverse event.
Singapore Regulatory record
| Regulator | Health Sciences Authority (HSA) |
|---|---|
| Category | Class 1 cell, tissue or gene therapy product (CTGTP) |
| Notification | HSA notification CTGT0041N, held by the manufacturer, Ventas Bio Pte Ltd |
| Manufacturer | Ventas Bio Pte Ltd, 2 Tukang Innovation Grove #07-02, JTC Medtech Hub, Singapore 618305 |
| Distributor and exporter | Santé Maison Pte. Ltd., UEN 202440255D |
HSA requires suppliers of Class 1 CTGTP to submit a product notification and receive HSA’s written acceptance before supplying the product in Singapore. Class 1 CTGTP are currently excepted from product registration. HSA keeps a public list of notified Class 1 CTGTP. HSA: Class 1 CTGTP notification
A notification is not an HSA approval or evaluation of the product’s performance.
Indonesia Regulatory record
| Regulator | Ministry of Health of the Republic of Indonesia (Kemenkes RI) |
|---|---|
| Registration | Izin edar AKL 20602420387 |
| Classification | Non-electromedical, sterile. Class C. Dental prosthetic equipment; bone grafting material |
| Pack registered | Box of 1 strip (4 × 0.25 cc) |
| Registrant | PT Global Sarana Trading, Bekasi |
| Valid until | 14 May 2027 |
Product documents
- AmGraft® Instructions for Use, date of information 2022-06 (PDF, Ventas Bio)
- AmGraft Product Catalogue, version 5.0: contact us for a copy
From the catalogue: “Regulatory clearance or licensing status may vary across different countries.”
Report an adverse event
The AmGraft® IFU says that adverse outcomes potentially attributable to the product must be promptly reported to Ventas Bio Pte Ltd or your distributor, and to your country’s competent authority. Please report to both.
1. The manufacturer or the distributor
| Ventas Bio Pte Ltd (manufacturer) | [email protected] · +65 6871 4004 2 Tukang Innovation Grove #07-02, Singapore 618305 |
|---|---|
| Santé Maison (distributor) | [email protected] · +65 6240 6900 If you report to us, we forward the report to Ventas Bio. |
Where you can, include the product name, the lot number and expiry date from the label, the date of the procedure and a description of the event.
2. The competent authority
- Singapore: report to HSA. Healthcare professionals: HSA guide to adverse event reporting for healthcare professionals; all reporting routes: HSA: Report adverse events.
- Indonesia: report to the Ministry of Health (Kemenkes RI) as well as to the manufacturer or distributor.
Companies that supply CTGTP in Singapore must report serious adverse events to HSA no later than 15 calendar days after becoming aware of them. HSA: Adverse event reporting of CTGTP