New 2025 Rules, Big Opportunity: Navigating NMPA Approval for IVF/ART Devices
Second post in our Regulatory Affairs series—giving IVF innovators a country-by-country roadmap to clearance.
1. Regulatory shake-up in 2025
China’s Medical Device Administration Law (MDAL, Q3 2025) rewrites the rules:
| What’s new? | Why it matters |
| MAH licence can be transferred between companies | Enables M&A exits or distributor swaps without re-registering the product |
| Joint liability for MAH + domestic distributors | Choose partners with impeccable compliance history |
| Innovation commitments required at renewal | Demonstrate ongoing product improvements to keep licence valid |
2. Device classification—AI can jump to Class III
| IVF Product | Likely Class | Pathway | Notes (AI Guidance 2025) |
| Catheter, pipette | II | Tech review | Filing if predicate exists |
| Culture media / oil | II (IVD) | Type test + tech review | Growth-factor media may be combo |
| AI embryo-scoring SaaS | II or III | Innovative Device / De Novo | Up-classified if it directly drives clinical decision-making |
| Time-lapse incubator | III | Tech + clinical | Embedded AI module = III |
Risk is now set by the clinical scenario, not code size.
3. Approval flow (imported Class II & III)
- (Optional) Classification confirmation – 3 mo.
- Appoint local MAH / Legal Agent – MDAL lets licences shift later if strategy changes.
- Type testing in China – 6–9 mo; Chinese IFU required.
- Clinical evaluation
- Literature or equivalence for many Class II.
- AI & media: RCT or overseas data that meet ethnic-relevance & GLP standards.
- QMS – ISO 13485 plus China annex. Remote GMP audits now allowed for some imported Class III devices.
- Registration dossier → CMDE.
- Technical review & licence
- Class II: ¥210 000, 16–24 mo.
- Class III: ¥310 000, 24–36 mo. Innovative channel can cut to 9–12 mo with 30 % fee reduction in Boao Lecheng pilot zone.
- Validity 5 yrs → renewal (show innovation progress).
4. UDI + cloud traceability
| Risk Class | UDI deadline | Extra 2025 rule |
| III | June 2022 | 100 % live |
| II (incl. IVF disposables) | June 2024 | Connected / AI devices must sync to NMPA UDI-cloud for real-time traceability |
| I | Draft July 2026 | — |
Failure to push data to the cloud blocks customs clearance.
5. Cybersecurity dossier—mandatory in 2025
All connected devices must file a Cybersecurity Risk-Management Report at registration and provide SBOM; patches within 45 days.
6. Post-market obligations
| Requirement | Class II | Class III / AI |
| SAE reporting | 15 days | 15 days |
| Annual real-world performance report | — | Yes (AI/ML) |
| Licence change filing | 60 days | 60 days |
7. Fast-track & pilot options
| Program | Benefit | IVF fit? |
| Innovative Device | 9–12 mo review, fee –15 % | AI embryo-scoring, novel incubators |
| Boao Lecheng Pilot | Temporary clinical use + extra 30 % fee cut + overseas clinical data via Cross-border Data Port | Ideal for early revenue & RWE |
| Clinical-trial exemption list | Skip local trial | Catheters often exempt; AI not |
8. Cold-chain & distribution
- Cold chain logs now mandatory in provincial tenders for temp-sensitive media.
- MAH/distributor share liability for storage per MDAL.
- Licence transferability allows MAH swap without new NMPA number—useful if changing distributors.
9. Pitfalls & fixes (2025)
| Pitfall | Impact | Fix |
| AI trained only on foreign data | Extra China RCT | Mix ≥ 30 % Chinese embryo dataset or justify relevance |
| No cloud-UDI connectivity | Port lock | Integrate API before type test |
| Marketing “clinically proven” claims | SAMR fine, licence suspension | Claims must match NMPA indications—extra scrutiny on AI |
10. Class II vs Class III snapshot
| Aspect | Class II | Class III |
| Type test | Yes | Yes |
| Clinical trial | Often waived | Usually required |
| Remote audit | Pilot only | Pilot allowed (imported) |
| Official fee | ¥210 000 | ¥310 000 |
| Review clock | 16–24 mo | 24–36 mo |
| Post-market RWP | If AI | Always if AI/ML |
11. Key takeaways
- MDAL 2025 brings licence transferability + joint liability—plan partnerships carefully.
- AI tools may be up-classified to Class III; overseas data can work if ethnically relevant.
- Remote GMP audits and Boao fee cuts can slash time & cost.
- UDI-cloud + cybersecurity report are now non-negotiable for connected devices.
- Fastest go-to-market = Innovative Device track + Boao pilot + a compliant distributor.
Ready to unlock China and secure NMPA-savvy partners?
Email info@findbestivf.com to request your One Country Free promo code and see how quickly FinDBest IVF matches you with top Chinese distributors.
Next in the series → “CE Marking IVF Devices under Europe’s MDR.”
