“Algosoup streamlined our registration process, which now takes much less time. We’ve seen an 80% time reduction.”
Xiaoxu · CEO, Dongchu TechnologyThe route starts with the product’s intended use
The workspace locks the intended use and configuration first. A qualified regulatory owner then records the route and the evidence behind it.
Every Chinese record links back to its source
Each translated record points to its original, its reviewers and its place in the dossier, so model names, claims and warnings stay consistent across the package.
AI drafts, people approve
AI prepares cited first drafts. Nothing is approved or submitted until a qualified reviewer signs it off.
Missing evidence becomes owned work
Checks catch missing signatures, stale versions and broken links. Each gap gets an owner and a fix.
Rule changes open an impact review
When an official source changes, the workspace opens a review for the regulatory owner.
- NMPA service portal
Submission and official product-record entry point
- Registration and filing rules
Route, language, agent, review and change duties
- Submission dossier requirements
Official dossier headings and evidence expectations
- Medical-device classification service
Official route for a new or category-ambiguous product
- Clinical laboratory device catalogue
Classification entries for clinical mass spectrometry and chromatography
- Triple-quadrupole LC–MS/MS guidance
Product-specific CMDE expectations for scope, performance and intended use
- Cross-border data rules
Boundary for personal, important and ordinary business data
- Revised medical-device GMP
Published QMS baseline · effective 1 November 2026
Need regulatory software built?
If you need a regulated workflow built and running in weeks, contact us.