China NMPA Quality Management System (QMS) Legislation to Take Effect November 1, 2026

By Janet Zhang, Amber Baade and Evangeline Loh

The regulator in China, NMPA, released the revised Medical Device Good Manufacturing Practices (GMP) (Announcement No. 107 of 2025). This impacts all manufacturers.

Announcement No. 107 of 2025 was released to bolster the GMP requirements for medical device manufacturers. The QMS legislation will take effect at the beginning of November 2026, and has an additional three chapters, as well as some reorganized topics.

Emphasis is placed on the following: quality risk management through the device lifecycle (R&D to after-sales service), quality assurance in the entire manufacturing process (Chapter 2), management of contract manufacturers with responsibilities at each stage (Chapter 12), importance of verification and validation (Chapter 9), and use of digital intelligence in the manufacturing process.

Additional NMPA materials

In a separate NMPA notice, the NMPA shared that, in addition to the topics of the newly added Chapters (2, 9, and 12), other changes were made to the existing chapters and articles.

An NMPA department has also published a comparison table with the updates.

Expectations for foreign manufacturers

Foreign manufacturers must still submit home country approval when applying for registration in China. This includes the evidence of the QMS. For example, manufacturers based in the European member states must provide ISO 13485 certification, whereas manufacturers from the U.S. must submit “Establishment Registration & Device Listing.”

However, the NMPA has yet to issue guidelines explaining how foreign manufacturers should comply with China’s GMP requirements.

Is this a change?

While the previous announcement was aligned with ISO 13485, this announcement further imposes additional detailed requirements. The NMPA may require manufacturers to provide a declaration of compliance with Announcement No. 107 of 2025 or impose no additional requirements.

In any case, if the NMPA were to conduct QMS audits of foreign manufacturers in the future, these would be performed in compliance with Announcement No. 107 of 2025. Some examples of differences between ISO 13485: 2016 and the new GMP requirements are described in the table.

QMS	ISO 13485:2016	China GMP (Announcement No. 107 of 2025)	Gap / Risk
Organizations and Personnel	ISO 6.2 Emphasizes “competence” based on “education, training, skills, and experience.”	NMPA Chapter 3 (Articles 17, 19, 20, 21) Mandatory requirements for the “qualifications” of “key personnel.” For example: Class II/III Quality Managers/Management Representatives must hold “a bachelor’s degree or higher in a relevant field” + “at least 3 years of experience.”	If a company currently has key personnel who are “competent” but ”do not meet the educational or experience requirements,” the company will no longer be in compliance after November 1, 2026.
Contract Manufacturing (Finished Products)	ISO 4.1.5 Requires control of outsourced processes and the establishment of a “written quality agreement.” The MAH retains responsibility but may delegate activities (such as release).	NMPA Chapter 12 (Articles 107–114): 1. Article 109: The MAH must conduct “on-site audit” and “periodic on-site inspections” of the Contract Manufacturing Organization (CMO). 2. Article 113: A mandatory “two-step release” process: The CMO performs the “manufacturing release,” while the MAH must perform the “marketing release” independently and may not delegate this responsibility.	If an MAH is unable to audit CMO batch records and perform “marketing release,” it will not be able to sell products in China.
Validation and Verification (V&V)	ISO 7.3 (V&V), 7.5.6 (PV): V&V is part of D&D. PV is covered in the production provisions.	NMPA New Chapter 9 (Art. 69-77): 1. V&V is now a separate chapter, emphasizing its importance. 2. Clarifies that the scope of V&V includes: Process Validation (PV) (Art. 72), Cleaning Validation (CV) (Art. 73), Computerized System Validation (CSV) (Art. 77), and Revalidation (Art. 75).	Organizations should have PV/CSV in place, but may lack an overall VMP (Validation Master Plan) or fail to explicitly cover CV and periodic Revalidation.
Quality Assurance (QA)	ISO Chapter 5 (Management) / Chapter 8 (Improvement): QA activities are scattered across clauses such as management review, CAPA, and internal audits.	NMPA New Chapter 2 (Art. 7–13): 1. A separate “Quality Assurance” chapter. 2. Clear definitions of QA, QC, and QMS (Art. 131.6). 3. Defines quality assurance as a systematic management function encompassing objectives (Art. 7), resources (Art. 8), changes (Art. 10), improvement (Art. 11), and risk (Art. 12).	A compliant ISO 13485 QMS should already include these activities. However, the NMPA has structured them and elevated the level of management responsibility.

Concluding remarks

This is an indication of the NMPA’s intent (Announcement No. 107 of 2025) to impose more rigorous GMP requirements in China. Emergo experts will continue to monitor these developments, particularly in advance of the implementation date.

Learn more about medical device regulations in China from Emergo by UL: