All SFDA Guidance — by Topic
How SFDA guidance is structured
The SFDA publishes two primary series of guidance documents for medical devices:
- MDS-REQ series — Requirements documents. These are binding in practice and must be followed to achieve MDMA. They translate the Medical Devices Law and Implementing Regulation into detailed compliance requirements.
- MDS-G series — Guidance documents. These provide interpretation, worked examples, and additional context. While not strictly binding, non-compliance with MDS-G guidance creates regulatory risk.
All documents are available from the SFDA website: Medical Devices → Regulations and Guidance → Guidance Documents.
By topic: registration and pre-market
| Document | Topic |
|---|
| MDS-REQ 1 | Requirements for Medical Device Marketing Authorization (MDMA) — core registration document covering classification rules, technical file structure, MDMA application process, Annexes 1–14 |
| MDS-REQ 2 | Essential Principles of Safety and Performance |
| MDS-REQ 4 | Clinical Evaluation requirements |
| MDS-G008 | Classification guidance — interpretation of classification rules, borderline products, Annex XVI devices |
| MDS-G (SaMD) | Guidance on Software as a Medical Device |
By topic: quality management systems
| Document | Topic |
|---|
| MDS-REQ 3 | Quality Management System requirements — ISO 13485, SFDA CABs, scope of QMS for different establishment types |
By topic: establishment licensing and in-country representation
| Document | Topic |
|---|
| MDS-REQ 6 | Medical Device Establishment License (MDEL) — types, eligibility, application |
| MDS-REQ 9 | Authorized Representative obligations |
By topic: post-market, vigilance, and advertising
| Document | Topic |
|---|
| MDS-REQ 5 | Post-Market Surveillance and Vigilance — PMS Reports, PSURs, adverse event reporting, FSCA |
| MDS-REQ 8 | Medical Device Advertising — pre-approval requirements, permitted and prohibited claims |
By topic: UDI and traceability
| Document | Topic |
|---|
| MDS-REQ 7 | Unique Device Identification (UDI) — structure, data submission, labelling requirements, compliance timelines |
By topic: labelling
| Document | Topic |
|---|
| MDS-REQ 1 (labelling section) | General labelling requirements |
| MDS-G (labelling) | Supplementary labelling guidance |
Downloading guidance documents
- Navigate to SFDA website
- Select Medical Devices from the top menu
- Navigate to Regulations and Guidance → Guidance Documents
- Documents are listed by MDS-REQ and MDS-G number
Always verify you are using the most current version — guidance documents are updated periodically without retroactive notification.
Further reading