Views: 2 Author: Site Editor Publish Time: 2026-11-02 Origin: Site
China's revised Good Manufacturing Practice for medical devices took effect on 1 November 2026. If you supply hook-and-loop straps, wristbands, cuffs or adhesive fasteners into a device bill of materials, the change is indirect but real: the manufacturer you sell to is now inspected against a new rulebook, and its supplier files sit inside that inspection.
The revised GMP was published as Announcement No. 107 of 2025 and replaces the 2014 version. The National Medical Products Administration notice of 15 September 2026 sets the transition: from 1 November, licensing audits and post-market inspections are carried out under the new GMP and judged against a new inspection guideline, while the 2015 field inspection guideline is withdrawn.
Two details matter when you plan production. Applications accepted before 1 November but not yet inspected are inspected under the new GMP. Class I devices filed before that date but not yet checked are also inspected under the new rules, because on-site review follows filing within three months.
Sterile, implantable, IVD, custom denture and standalone software products must additionally meet the relevant appendix requirements; those appendices are being revised separately.
Hook-and-loop tape is a component, not a device, so a tape factory is not the inspected party. The effect reaches suppliers through the customer: a device maker under audit must show that purchased materials are controlled, traceable and change-managed. In practice that conversation reaches the fastening supplier within one audit cycle.
Requests usually arrive as a supplier questionnaire plus a document pack. The five items below cover most of what medical and wearable customers ask us for.
Document | What it should show | Typical gap |
|---|---|---|
Quality system certificate | ISO 9001 scope that names hook-and-loop production, not a trading scope | Certificate scope covers trading only |
Material compliance declaration | RoHS and REACH statements for the exact construction, including adhesive and liner | Declaration names the fabric but not the adhesive |
Flammability test report | The standard your customer's product is judged against, with the sample form stated | Report tested bare tape, while the assembly includes adhesive |
Batch record and COA | Roll number, batch number and shipment linked in one line | Batch code on the carton cannot be traced to a coating lot |
Change notification | Written notice before an adhesive, fabric or treatment change | Change is disclosed only after the shipment arrives |
Fastening tape looks simple, but three inputs move performance: the adhesive system, the base fabric and any flame-retardant treatment. A supplier that switches an adhesive lot or a release liner without telling the customer breaks the device maker's change control, even if the tape still passes incoming inspection. Written notice, plus a sample for re-validation, is the cheapest insurance in the chain.
The same logic applies to cleaning. If the strap is used on a reusable device, disinfection can change both adhesion and flame performance, so the qualification should be run after the cleaning cycle rather than before it.
Confirm the scope on your ISO 9001 certificate matches what you actually ship.
Re-issue compliance declarations so they name adhesive, liner and fabric separately.
Check that every flammability report states the sample form and the standard version.
Test one shipment end to end: carton code to coating lot to inspection record.
Write a one-page change notification procedure and give it to your key accounts.
If you need current test data for a specific construction, start with our medical and wearable overview and the flame retardant test guide. The effect of cleaning cycles is covered in a separate note.
This note summarises the published timetable and is not a legal interpretation. Confirm the requirements that apply to your product with your customer's quality team.
