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WTO notification · TBT

ChinaProposed measure, not in force yet

National Standard of the P.R.C., Sterilization of health

Official title

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

China notified this proposed TBT measure to the WTO on 4 June 2026. The comment period closed on 3 August 2026.

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Source: WTO ePing (opens in a new tab). Summaries by Expodite, which is independent of the WTO.

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At a glance

Products

Medical devices sterilized by moist heat using saturated steam, steam or air-steam mixed gas, water spray, water immersion, etc

HS codes
  • 30 · Pharmaceutical products
    • 300590 Wadding, gauze, bandages and the like, e.g. dressings, adhesive plasters, poultices, impregnated or covered with pharmaceutical substances or put up for…
  • 39 · Plastics and articles thereof
    • 392329 Sacks and bags, incl. cones, of plastics (excl. those of polymers of ethylene)
  • 70 · Glass and glassware
    • 701790 Laboratory, hygienic or pharmaceutical glassware, whether or not graduated or calibrated (excl. glass having a linear coefficient of expansion <= 5 x 10 -6…
  • 84 · Machinery and mechanical appliances, boilers, nuclear reactors; parts thereof
    • 842129 Machinery and apparatus for filtering or purifying liquids (excl. such machinery and apparatus for water and other beverages, oil or petrol-filters for…
  • 90 · Optical, photographic, cinematographic, measuring, checking, medical or surgical instruments and apparatus; parts and accessories
    • 901831 Syringes, with or without needles, used in medical, surgical, dental or veterinary sciences
    • 901839 Needles, catheters, cannulae and the like, used in medical, surgical, dental or veterinary sciences (excl. syringes, tubular metal needles and needles for…
    • 902131 Artificial joints for orthopaedic purposes
Notifying member
China
Status
Proposed measure, not in force yet
Objectives
  • Protection of human health or safety
  • Quality requirements
Area
TBT: Technical product rulesTechnical barriers to trade
Notification type
Regular notification
Document symbol
G/TBT/N/CHN/2259

Key dates

Distributed by the WTO
Comment deadline
Closed on 3 August 2026
Proposed adoption
To be determined
Proposed entry into force
To be determined

How to comment

The comment period closed on 3 August 2026. You can still raise concerns about the measure with your country's WTO TBT enquiry point, quoting the document symbol G/TBT/N/CHN/2259; it can take them up with China.

Find your country's enquiry point on WTO ePing (opens in a new tab)

What the notification says

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.

Sources

Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.

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