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WTO notification · TBT

KazakhstanProposed measure, may since have been adopted

Draft amendments to the Requirements

Official title

Draft amendments to the Requirements for the implementation, maintenance and evaluation of the quality management system of medical devices, depending on the potential risk of their use

Kazakhstan notified this proposed TBT measure to the WTO on 26 March 2026. The comment period closed on 25 May 2026.

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

Published here:

At a glance

Products

Cotton wool, gauze, bandages and similar articles (for example, bandages, Band-Aids, poultices), impregnated or coated with pharmaceutical substances or packaged in forms or packages for retail sale, intended for use in medicine, surgery, dentistry or veterinary medicine (HS 3005); Devices and instr

HS codes
  • 30 · Pharmaceutical products
    • 30
  • 90 · Optical, photographic, cinematographic, measuring, checking, medical or surgical instruments and apparatus; parts and accessories
    • 90 OPTICAL, PHOTOGRAPHIC, CINEMATOGRAPHIC, MEASURING, CHECKING, PRECISION, MEDICAL OR SURGICAL INSTRUMENTS AND APPARATUS; PARTS AND ACCESSORIES THEREOF
  • 94 · Furniture; bedding, mattresses, mattress supports, cushions and similar stuffed furnishings; lamps and lighting fittings, n.e.c.; illuminated signs, illuminated name-plates and the like; prefabricated buildings
    • 94 FURNITURE; BEDDING, MATTRESSES, MATTRESS SUPPORTS, CUSHIONS AND SIMILAR STUFFED FURNISHINGS; LUMINAIRES AND LIGHTING FITTINGS, NOT ELSEWHERE SPECIFIED OR…
Notifying member
Kazakhstan
Status
Proposed measure, may since have been adoptedNotified as a draft on 26 March 2026. Check WTO ePing or Kazakhstan for its current status.
Objectives
  • Protection of human health or safety
Area
TBT: Technical product rulesTechnical barriers to trade
Notification type
Regular notification
Document symbol
G/TBT/N/KAZ/35

Key dates

Distributed by the WTO
Comment deadline
Closed on 25 May 2026
Proposed adoption
To be determined
Proposed entry into force
To be determined

How to comment

The comment period closed on 25 May 2026. You can still raise concerns about the measure with your country's WTO TBT enquiry point, quoting the document symbol G/TBT/N/KAZ/35; it can take them up with Kazakhstan.

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

What the notification says

The draft amendments to the Requirements for the implementation, maintenance and evaluation of the quality management system of medical devices, depending on the potential risk of their use, apply to medical devices put into circulation in the territory of the Eurasian Economic Union and provide for the following: the possibility, in certain situations, of confirming the compliance of the production conditions of the sterilization site with the established requirements without the inspection organization visiting the sterilization site, which will avoid repeating individual procedures when evaluating the quality management system in order to rationalize the resources of manufacturers of medical devices and inspecting organizations

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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