Medical electrical equipment will implement the new standard GB9706.1 starting from May 1, 2023.
　　
On October 13, 2022, the State Drug Administration (NMPA) held a meeting to put forward clear work requirements for promoting the implementation of the new version of the GB 9706 series of standards. Urge medical electrical equipment manufacturers and their legal representatives of the State Food and Drug Administration to effectively perform their duties and ensure the smooth and orderly implementation of the new version of GB 9706.1 and supporting standards.
　　
Conference highlights
　　
Current status of GB 9706 series standards
　　
GB 9706.1-2020 “Medical electrical equipment-Part 1: General requirements for basic safety and essential performance” and its supporting parallel standards will be implemented one after another starting from May 1, 2023. They are the basic standards for medical electrical equipment in my country. The new version of the series of 76 The changes have far-reaching impacts, the standard level has been greatly improved, and the industry needs to commit to high-quality development.
　　
primary responsibility
　　
Registrants have the primary responsibility for the implementation of the standards. The legal representative, main person in charge, person in charge of production, quality, and production technology management of the State Food and Drug Administration, and inspection personnel of all relevant enterprises must carefully study the new standards and master the standard requirements.
　　
Registrants should strictly implement the new series of standards in accordance with the requirements to ensure that products produced from the date of implementation of the standards meet the requirements. From now on, registrants are strongly encouraged to register only products that already meet the new standards and start internal product inspections in accordance with GB 9706.1-2020.
　　
Impact on manufacturers
　　
GB 9706.1-2020 was released on April 9, 2020, and the company should have begun efforts to meet these standards by the full implementation date of May 1, 2023. Because these new standards will apply to the following products:
　　
·Already listed in China
　　
·Registration or updating
　　
·Registration or update soon
　　
GB9706.1.2020 modifies the content of International Electrotechnical Commission (IEC) 60601-1:2012. Therefore, starting from May 1, 2023, products need to comply with the China standard GB9706.1.2020 instead of the IEC standard.
　　
Starting from May 1, 2023, the State Food and Drug Administration will order corrections or confiscation of medical devices that do not meet the new standards in accordance with the provisions of Article 86 of the Regulations on the Supervision and Administration of Medical Devices.
　　
Sanctions for substandard medical devices
　　
If the value of the goods is less than 10,000 yuan (US$1350), a fine of 20,000 yuan (US$2700) to 50,000 yuan (US$6850) will be imposed
　　
If the value of the goods exceeds 10,000 yuan (US$1350), a fine of 5 to 20 times the value of the goods will be imposed.
　　
Revoke the medical device registration certificate, medical device production license, and medical device business license.
　　
Starting from May 1, 2023, fines will be imposed on any income earned from substandard products sold in China. This will exceed 30% of the revenue earned, but no more than 3 (three) times.
　　
Any company that sells substandard products in China starting from May 1, 2023 may be prohibited from engaging in the production and operation of medical devices for 10 (ten) years.
　　
It is recommended that China medical electrical equipment manufacturers obtain guidance from their NMPA legal representatives to understand the full impact on their products.