Lifecycle Checkpoints of Cosmetic Devices Released

NMPA issued the “Checkpoints of Common Violations of Regulations in the Production, Supply and Usage of Medical Cosmetic Devices” on November 25, 2022. It asks local NMPA offices to strengthen the supervision and inspection of cosmetic devices based on this document.

For “Cosmetics Production and Operation Measures” which has been effective since January 2022, please click HERE

For cosmetic devices entering Hainan RWD pathway, please click HERE

Common Violations

Violation 1 Production of Class II and Class III medical devices that have not obtained a medical device registration certificate

• Whether the Class II and Class III medical devices produced have obtained the Device Registration Certificate
• Whether the actual product name, specification model, structure composition and other product description information are consistent with the information stated in the product registration certificate
• Whether the product is produced within the validity period of the registration certificate
• Whether the registration certificate is valid, by verifying function on website of NMPA

Violation 2 Production of medical devices that do not meet mandatory standards or do not meet the product technical requirements (PTRs) of registered device

• Check whether the enterprise has failed the product sampling inspection and dispose of the enterprise that does not meet the mandatory standards or does not meet the registered or filed product technical requirements according to law.

Violation 3 Failure to organize production with the PTR of registered product, or failure to establish a QMS based on related regulations

• Check whether the enterprise organizes production in strict accordance with the PTR of registered product, and whether the quality system has serious defects which affect product safety and effectiveness.

Violation 4 Changes in production conditions may affect the safety and effectiveness of products, and production is not reported in accordance with the provisions

• Check whether the factory floor plan, production workshop layout drawing, production equipment list and other information provided by the enterprise are consistent with the actual situation of the on-site workshop and production line.

Violation 5 Production of medical devices whose instructions and labels do not comply with regulations

• Whether the content of the instruction manual and label is consistent with the relevant content of the registration and whether the content of the manual label meets the requirements of the Provisions on the Administration of Medical Device Instructions and Labels.

Violation 6 Medical device registrants manufacturers fail to carry out adverse event monitoring of medical devices in accordance with regulations, fail to report adverse events as required, or do not cooperate with adverse event investigations conducted by medical device adverse event monitoring technical institutions, departments responsible for drug supervision and administration, and health authorities

• Check whether the enterprise has established a relevant management system for carrying out adverse event monitoring
• Check whether the enterprise has carried out adverse event monitoring and reporting in accordance with relevant regulations.

Violation 7 Production of Class II and Class III medical devices beyond the production scope specified in the medical device production license

• Check whether the enterprise has produced Class II and Class III medical devices beyond the production scope specified in the medical device production license.

Violation 8 Production of Class II and Class III medical devices at an unlicensed production site

• Check whether the enterprise has produced Class II and Class III medical devices at an unlicensed production site.

Violation 9 Substantially changing the design, raw materials, production process, scope of application, method of use, etc. without authorization, and may affect the safety and effectiveness of the medical device

• Check whether the product name, raw materials, production process, model, specification, structure and composition, scope of application and product technical requirements are consistent with the contents stated in the registration certificate and its annexes.

Above checkpoints are for production phase. For a full English document with violations on supply and usage, please email info@ChinaMedDevice.com.

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• Source: https://chinameddevice.com/nmpa-cosmetic-devices/