China medical electrical equipment will be subject to the new standard GB9706.1 from May 1, 2023.
To help promote the implementation of the new GB 9706 standards series, the National Medical Products Administration (NMPA) held a meeting on October 13, 2022. During the meeting, clear work requirements were set out. Manufacturers of medical electrical equipment and their NMPA legal agents were urged to fulfill their responsibilities to ensure the smooth and orderly implementation of the new GB 9706.1 and the supporting standards.
Status of GB 9706 series standards
GB 9706.1-2020 “Medical Electrical Equipment Part 1: General requirements for basic safety and basic performance” and its supporting parallel standards will be implemented one after another from May 1, 2023. It is the basic standard for China medical electrical equipment and this new series has 76 changes, which have far-reaching and much-increased levels of standards meaning the industry will need to commit to high-quality development.
Registrants have the main responsibility for the implementation of the standards. The NMPA legal agent, main responsible person, responsible person for production, quality, technical production management, and inspection employees of all relevant enterprises should study the new standards in detail and master the standard requirements.
Registrants shall strictly implement the new series of standards according to the requirements, ensuring that the products manufactured from the implementation date of the standards meet the requirements. From now on registrants are strongly encouraged to only register products that already meet the new standards as well as to commence internal product inspection according to GB 9706.1-2020.
Impact for manufacturers
GB 9706.1-2020 was published on April 9, 2020, and companies should already be working towards meeting these standards for the date of full implementation on May 1, 2023. As these new standards will apply to products that are:
• already on the market in China
• being registered or renewed
• about to be registered or renewed
GB9706.1.2020 modified the content of International Electrotechnical Commission (IEC) 60601-1:2012. Therefore, products from May 1, 2023, need to comply with the China standard GB9706.1.2020 rather than the IEC standard.
Any medical devices that do not comply with the new standards as of May 1, 2023, will receive corrective action orders or be confiscated by the NMPA according to the provisions of Article 86 of the Regulations on the Supervision and Administration of Medical Devices.
Sanctions levied on non-conform medical devices
- If the value of the goods is less than 10,000 yuan (USD 1350), a fine of not less than 20,000 yuan (USD 2700) but not more than 50,000 yuan (USD 6850) will be imposed
- If the value of the goods is more than 10,000 yuan (USD 1350), a fine of more than 5 times but not more than 20 times the value of the goods will be imposed.
- The medical device registration certificate, medical device production license and medical device business license will be revoked.
- A fine on any income obtained from non-conforming products that are sold in China from May 1, 2023, onwards. This will amount to more than 30% but not more than 3 (three) times the income obtained.
- Any company selling non-conforming products sold in China from May 1, 2023, can be prohibited from engaging in the production and operation of medical devices for a period of 10 (ten) years.
China medical electrical equipment manufacturers are advised to obtain guidance from their NMPA Legal Agent to understand the full implications for their products.
For guidance on how the GB9706.1 affects your medical electrical equipment or for more information on our medical device and IVD registration services, please contact us.