China NMPA Releases Four Medical Device Industry Standard Amendment Notices (No. 68 of 2026)

On July 24, 2026, the National Medical Products Administration officially released the Announcement No. 68 of 2026, approving four medical device industry standard amendments. These amendments were approved on July 21, 2026, and are now published for implementation.

Standard 1: YY 0830—2011 Superficial Tissue Ultrasonic Therapy Equipment (Amendment No. 1)

Effective 24 months after publication

This amendment introduces substantial technical updates to ultrasonic therapy equipment standards:

l Normative References: Updated GB/T 7966 from the 2009 to the 2022 edition; removed GB/T 14710 (Environmental requirements) and GB 9706.15 (System safety requirements).

l Terminology: Revised the definition of "superficial tissue ultrasonic therapy equipment" to focus on "therapeutic purposes" rather than specifying "degeneration and/or necrosis." Added a new definition for "temporal-maximum output acoustic power" with a detailed formula for amplitude-modulated waves.

l Classification: Changed output waveform classification from "continuous wave, pulse wave" to "continuous wave, amplitude-modulated wave (or pulse wave)."

l Output Power Accuracy (5.1.1): For continuous wave mode, the rated output acoustic power must be published; for amplitude-modulated (or pulse wave) mode, both rated output acoustic power and rated temporal-maximum output acoustic power must be published. Deviation shall not exceed ±20%.

l Output Control Device (5.1.3): Changed tolerance from "±30% or lower" to "30% or lower."

l Output Indication (5.1.4): Updated to specify "temporal-maximum output acoustic power" under amplitude-modulated (or pulse wave) mode.

l Environmental Testing: Removed sections 5.11 and 6.11 entirely.

l Test Methods (6.1.1): Updated to GB/T 7966—2022; added a new measurement method for temporal-maximum output acoustic power using hydrophone positioning.

l Safety Testing: Removed the clause on GB 9706.15 compliance.

l Inspection Rules: Deleted Section 7 entirely.

l References: Added YY/T 1090 (Ultrasonic physiotherapy equipment), YY 0592 (High-intensity focused ultrasound therapy systems), and YY/T 0644 (Ultrasonic surgical systems).

Standard 2: YY/T 1120—2021 Dentistry - Operating Lights (Amendment No. 1)

Effective immediately upon publication

l Normative References: Replaced YY/T 0316—2016 (ISO 14971:2007) with GB/T 42062—2022 (ISO 14971:2019, IDT).

l Splatter Requirements (5.3.5): Updated the risk analysis requirement from YY/T 0316 to GB/T 42062.

Standard 3: YY/T 1737—2020 Analytical Methods for Bioburden Control Levels of Medical Devices (Amendment No. 1)

Effective immediately upon publication

l Normative References: Replaced YY/T 0287 with GB/T 42061 (Quality management systems - Requirements for regulatory purposes); replaced YY/T 0316 with GB/T 42062 (Risk management).

l Chapter 4: Updated risk source identification requirement from YY/T 0316 to GB/T 42062.

l Section 7.2: Updated corrective and preventive action requirements from YY/T 0287 to GB/T 42061.

Standard 4: YY/T 1755—2021 Dentistry - Air-polishing handpieces and powders (Amendment No. 1)

Effective immediately upon publication

l Normative References: Replaced YY/T 0316—2016 (ISO 14971:2007) with GB/T 42062—2022 (ISO 14971:2019, IDT).

l General Requirements (5.1.1 & 5.2.1): Updated both clauses to reference GB/T 42062 instead of YY/T 0316.

These amendments reflect China's continued alignment with international standards, particularly the adoption of ISO 14971:2019 (GB/T 42062) and ISO 13485:2016 (GB/T 42061), strengthening risk management frameworks across the medical device industry.