EFFECTIVE 2026-11-01 · ~3 MONTHS OUT

2026 GMP Readiness Check
is your contract manufacturer ready for November?

China's revised device GMP adds a dedicated chapter on contract manufacturing. Five questions worth asking now — and how we answer each one.

On 4 November 2025, NMPA published a revised Good Manufacturing Practice for Medical Devices (Announcement No. 107 of 2025). It takes effect 1 November 2026, expanding from 10 chapters / about 80 articles to 15 chapters / 132 articles — with new chapters on quality assurance, verification and validation, and, for the first time, contract manufacturing and external processing.

If a Chinese contract manufacturer makes your device, this is the one part of the revision that reaches you directly. For the full breakdown of what changed, see our detailed article. This page is the short version: five things to check, and where we stand on each.

The checklist

Five questions to put to your contract manufacturer

Ask these of any manufacturer — including us — before the effective date

1. Does your quality agreement allocate responsibility article by article, or only in general terms?
A regulation that clarifies responsibility per stage tends to expose agreements written in general terms.
2. Who owns verification and validation — you, or the manufacturer?
With verification and validation elevated to its own chapter, the division of IQ/OQ/PQ and test-method validation work deserves to be written down explicitly, not assumed.
3. How is change control handled across both organizations?
If your manufacturer changes a process, material or supplier, what triggers a notification to you, and what triggers your approval?
4. Does your manufacturer use external processing (外协加工), and do you know about it?
External processing is now named alongside contract manufacturing. If a fourth party touches part of your product, that should be visible to you.
5. Does your manufacturer have a documented transition plan for the new regulation?
Quality systems built to the 2014 version need review against 15 chapters, not 10. Ask for the plan, not the reassurance.
Where we stand

Our own answers, today

Not a promise for November — our current position

Quality agreement
Being reviewed article-by-article against the revised regulation ahead of the effective date.
Inspection record
First contract manufacturing project passed the registration quality system inspection with zero findings (March 2023) — a public record, not a claim.
Certification base
ISO 13485:2016 and ISO 9001:2015, certified December 2023, covering all three licensed device categories.
What we won't claim
We are not going to tell you the full compliance impact from chapter headings alone. Implementation guidance may still follow, and we say so directly.

Source: NMPA, Announcement No. 107 of 2025, published 2025-11-04, effective 2026-11-01. This page is a readiness checklist, not a clause-by-clause analysis and not regulatory advice.

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