Global Medical Device Classification Decision Maker
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About this skill
Problem to Solve
Before registration, the most costly mistake in medical device projects is usually classification. The same product can land in different risk classes under FDA, MDR, NMPA, and PMDA. Small attribute changes—sterile versus non-sterile, added powered components, diagnostic claims, or combination with a drug—can change the inspection, clinical, and submission path. If a product is first treated as Class I or Category I, later compliance work may need to be redone.
How It Works
The skill takes a product description and extracts the decision-relevant attributes: powered or battery operation, human invasiveness, duration of use, presence of drug or biologically active substances, life support or diagnostic use, and whether software provides clinical decisions. It then evaluates each regulator separately:
- FDA: maps the product to one of 16 panels, searches for a predicate device, and flags De Novo when no suitable predicate exists.
- MDR: applies the 22 Annex VIII rules for non-invasive, invasive, implantable, active, and software-related cases.
- NMPA: locates the level-1, level-2, and level-3 code in the 2017 classification catalogue and derives Category I, II, or III.
- PMDA: outputs Class I-IV with the corresponding filing, certification, or approval route.
It returns a comparison table, the key regulatory basis, boundary-case warnings, and next-step registration recommendations.
Boundaries
It is useful for early design reviews, registration route estimation, and document planning, but it does not replace legal counsel, notified bodies, or formal regulator decisions. For implantable devices, powered components, sterile claims, diagnostic claims, or drug-device combinations, official classification catalogues and technical documentation remain authoritative.
Use Cases
- Product managers use a product description to determine FDA and MDR class and registration route.
- Regulatory specialists verify NMPA catalog codes and the corresponding I/II/III category before filing.
- Hardware engineers assess whether adding a battery or clinical algorithm changes risk classification.
- RA teams confirm predicate device, MDR rule, or De Novo path before preparing submission documents.
Best For
- Medical device product managers: defining risk classes under FDA, MDR, NMPA, and PMDA.
- Regulatory specialists: verifying catalog codes, MDR rule numbers, and registration routes.
- Hardware engineers: assessing whether powered parts, sterility, or software raise class.
- RA engineers: preparing 510(k), PMA, notified-body, or NMPA filing documents.
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