G/TBT/N/CHN/2259

4 June 2026

(26-4116)

Committee on Technical Barriers to Trade

Original: English

1.

Notifying Member: CHINA

If applicable, name of local government involved (Articles 3.2 and 7.2):

2.

Agency responsible:

State Administration for Market Regulation (Standardization Administration of the P.R.C.)

3.

Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], 3.2 [ ], 7.2 [ ], Other:

4.

Products covered (HS codes or national tariff lines. ICS numbers may be provided in addition, where applicable): Medical devices sterilized by moist heat using saturated steam, steam or air-steam mixed gas, water spray, water immersion, etc. (HS code(s): 300590; 392329; 701790; 842129; 901831; 901839; 902131); (ICS code(s): 11.080.10)

5.

Details of notified document(s) (title, number of pages and languages, means of access): National Standard of the P.R.C., Sterilization of health care products—Moist heat—Requirements for the development,validation and routine control of a sterilization process for medical devices; (118 page(s), in Chinese)

Link to notified document(s) and/or contact details for agency or authority which can provide copies upon request:

https://members.wto.org/crnattachments/2026/TBT/CHN/26_02954_00_x.pdf

6.

Description of content: This document specifies requirements for the development, qualification, and routine control of moist heat sterilization processes for medical devices, applicable to industrial sterilization applications.

This document contains guidance intended to explain requirements set forth in the normative sections, so as to promote good practices related to moist heat sterilization processes specified herein.

This document does not apply to the development, qualification, and routine control of processes for the inactivation of agents causing transmissible spongiform encephalopathies (e.g., scrapie, bovine spongiform encephalopathy, and Creutzfeldt-Jakob disease).

This document does not specify occupational safety requirements related to the design and operation of moist heat sterilization facilities.

7.

Objective and rationale, including the nature of urgent problems where applicable: Protection of human health or safety; Quality requirements

8.

Relevant documents:

-

9.

Proposed date of adoption: To be determined

Proposed date of entry into force: To be determined

10.

Provision of comments

Final date for comments: 3 August 2026

[X] 60 days from notification

Contact details of agency or authority designated to handle comments regarding the notification:

WTO/TBT National Notification and Enquiry Center of the People's Republic of China

Tel：+86 10 57954633/ 57954627

E_mail: tbt@customs.gov.cn