A China master file is a reference, not an approval
Five implant-grade polycarbonate grades carry a China National Master File registration. Here is what a device maker can actually do with that — and the three things it does not do.
What a master file is
A master file is a dossier of material-level information — composition, manufacturing process, quality controls, test data — filed with the regulator and held by the material supplier. The device applicant does not re-submit that documentation. It references the file, and the regulator reviews the material there.
For a coating, a tubing compound or an implant component, this removes a large block of duplicated paperwork from a device submission, and it keeps responsibility for the material where the knowledge is.
What it saves
- The material section of a device submission can point at an existing file instead of being rebuilt from scratch.
- Material change control stays with the material manufacturer, so a supplier-side process change is handled in one place rather than re-litigated in every customer's dossier.
- The material's identity is fixed by the file, which makes a later "is this the same material?" question answerable.
What it does not do
It does not approve a device. The device still needs its own registration, its own clinical or evaluation route and its own label. A master file has never made a catheter approvable on its own.
It does not replace device-level biocompatibility testing. ISO 10993 evaluates the finished device in its final form — the extractables from the actual process, the actual surface, the actual contact category and duration. Material-level implant data supports that evaluation; it does not pre-empt it.
It does not travel. A file covers the grades listed in it, from this manufacturer. It does not transfer to a different grade, a different supplier's equivalent, or a reformulated version.
The sequence that actually works
Fix four things before the paperwork starts: the grade, the contact category (surface device / external communicating / implant), the contact duration, and the sterilisation method. Those four decide which data package is relevant.
Then request the material package for that grade and that intended use, run the device-level evaluation on the finished device, and reference the master file in the submission. Done in that order, the file saves months. Done in the reverse order — picking a grade because it has a file — it saves nothing, because the grade may not suit the device.