Globally Certified, Quality Beyond Promises #
Hsiner’s quality and regulatory credentials cover the major medical device markets. The company states that its certifications and market approvals are maintained through an ISO 13485-based quality system and an independent regulatory affairs function.
Quality System Certifications #
| Certification | Scope / note |
|---|---|
| ISO 13485 | Medical device quality management system; certificates issued by DNV and BSI are listed on the official download page. |
| MDSAP | Medical Device Single Audit Program certification, covering regulatory requirements across five countries (United States, Canada, Brazil, Australia and Japan). Achieved in 2019. |
| Japanese Overseas Manufacturer Accreditation (QMS) | Accreditation for the Japanese market; certificate listed on the official download page. |
Product Market Approvals #
| Market | Approval / status |
|---|---|
| United States | FDA 510(k) clearance |
| European Union | CE mark — MDD obtained; MDR transition in progress |
| China | CFDA approval |
| South Korea | KFDA approval |
| Taiwan | GMP certification |
Other Quality Documents #
The official download page also lists:
- BSI confirmation letter
- DNV confirmation letter
- CE certificate
- ISO 13485 certificates (DNV and BSI)
- Japanese Overseas Manufacturing Accreditation
- MDSAP certificate
- CFDA and FDA documents
- IFUs and labels
Download certificates and documents · Quality management · Official quality page
A Note on Verification #
Certification status and scope can change over time. For procurement, regulatory submission or supplier qualification, verify the current certificate and its scope directly with Hsiner or through the official certificate documents linked above.