Regulation
Reading a bone graft’s registration: what HSA notification and Indonesian izin edar mean
Human-tissue grafts in Singapore are notified to HSA as Class 1 CTGTP; in Indonesia every imported device needs an izin edar. What each means, how to check it, and what it does not tell you.
Vol. 1No. 053 min read5 references
Before a graft reaches a clinic it passes through a regulator. Singapore and Indonesia handle this differently, and the words used (notification, registration, izin edar) mean different things. This article explains what each one covers, how to check it, and what it does not tell you about a product.
Singapore: grafts made from human tissue are CTGTP
In Singapore, health products that contain viable or non-viable human cells or tissues are regulated by the Health Sciences Authority (HSA) as cell, tissue and gene therapy products (CTGTP), under the Health Products Act and the Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021.1
Source 1
- 1 Health Sciences Authority, 2026. Regulatory overview of cell, tissue and gene therapy products (last updated 14 April 2026)
CTGTP are divided into two risk classes. A product is Class 1 (lower risk) only if it meets all three of these criteria:1
- it is minimally manipulated
- it is intended for homologous use
- it is not combined or used with therapeutic products or medical devices.
HSA gives “bone grafts for orthopaedic indications” as an example of a Class 1 CTGTP.1
Notification, not registration
Class 1 CTGTP are currently excepted from product registration. Instead, the supplier must submit a product notification and receive HSA’s written acceptance before supplying the product in Singapore.2 Changes, such as a new tissue procurement site or manufacturer, must also be notified. Notified products appear on HSA’s public list of Notified Class 1 CTGTP.2
Source 2
- 2 Health Sciences Authority. Class 1 CTGTP Notification
The supplier remains responsible for making sure that the product was sourced from an accredited or licensed facility and is free from infectious agents, and that the notification is accurate and up to date.2
Dealers must notify too
Companies that import, wholesale or manufacture minimally manipulated CTGTP must notify HSA before they start. Known dealers must keep records of supply, maintain traceability, keep records of defects and adverse effects, report defects and adverse effects, and notify HSA about recalls.3
Source 3
- 3 Health Sciences Authority, 2026. Dealer’s notice (CTGTP) (last updated 13 March 2026)
Why you see less product promotion
HSA’s rules prohibit CTGTP advertisements directed to the public. Advertising may be directed to healthcare professionals. Information on corporate websites must be non-promotional.4 Advertisements also must not claim endorsement by a public authority or include endorsements by healthcare professionals, and must stay within the product’s notified intended uses.4
Source 4
- 4 Health Sciences Authority, 2026. Advertisements and promotions of CTGTP (last updated 13 March 2026)
This is why responsible suppliers keep product detail behind a professional declaration and keep public pages factual.
Indonesia: every imported device needs an izin edar
In Indonesia, medical devices that are produced, imported, assembled or repackaged for circulation must hold an izin edar (marketing authorisation) issued under the Minister of Health.5 The governing regulation is Permenkes No. 62 of 2017.
Source 5
- 5 Peraturan Menteri Kesehatan Republik Indonesia Nomor 62 Tahun 2017 tentang Izin Edar Alat Kesehatan, Alat Kesehatan Diagnostik In Vitro dan Perbekalan Kesehatan Rumah Tangga.
Risk classes A to D
The regulation classifies medical devices by the risk their use poses to patients:5
| Class | Risk |
|---|---|
| A | low |
| B | low to moderate |
| C | moderate to high |
| D | high |
Who holds it, and for how long
An izin edar is valid for up to five years. When it is applied for by a distributor (Penyalur Alat Kesehatan, PAK) appointed as sole agent or distributor, its validity follows the period of that appointment.5 So the registrant named on an Indonesian certificate is often the local distributor, not the manufacturer.
What a registration tells you, and what it does not
A notification or izin edar tells you that the product may lawfully be supplied, within its stated intended use, by the named company. It does not compare the product with others. It is also not a statement that a regulator recommends it: HSA’s advertising rules prohibit falsely claiming endorsement by a public authority.4
When you assess any graft:
- Check the intended use and indications in its Instructions for Use.
- Check who holds the notification or izin edar, and for which country.
- For Indonesia, check the risk class and the expiry date.
AmGraft®
AmGraft® is manufactured in Singapore by Ventas Bio Pte Ltd. The HSA notification for AmGraft, CTGT0041N, is held by the manufacturer, Ventas Bio. Santé Maison is a distributor and exporter of the product. You can check the notification against HSA’s public list of Notified Class 1 CTGTP.2
AmGraft’s Indonesian registration details (number, class, registrant and validity) are on our regulatory page.
References
- 1Health Sciences Authority. Regulatory overview of cell, tissue and gene therapy products (last updated 14 April 2026).
- 2Health Sciences Authority. Class 1 CTGTP Notification.
- 3Health Sciences Authority. Dealer’s notice (CTGTP) (last updated 13 March 2026).
- 4Health Sciences Authority. Advertisements and promotions of CTGTP (last updated 13 March 2026).
- 5Peraturan Menteri Kesehatan Republik Indonesia Nomor 62 Tahun 2017 tentang Izin Edar Alat Kesehatan, Alat Kesehatan Diagnostik In Vitro dan Perbekalan Kesehatan Rumah Tangga.
- AKL
- CTGTP
- HSA
- medical device registration
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General education for dental professionals. Not advice on the care of any individual patient. Statements about AmGraft® follow its Instructions for Use (2022-06). AmGraft® is manufactured by Ventas Bio Pte Ltd and distributed by Santé Maison.
