In late March 2021, China’s National Medical Products Administration (NMPA, formerly CFDA) published the revised Regulations on the Supervision and Administration of Medical Devices. This version of regulations was postponed until March 2021 due to re-prioritization of tasks of NMPA in response to the COVID-19 pandemic. The updated regulatory framework was slated to take effect on June 1, 2021.
The original draft of the regulatory update was published in June 2018. In it, China’s NMPA set similar goals as those set forth in Europe’s Medical Device Regulation (MDR). The objectives of the latest revised version of Regulations on the Supervision and Administration of Medical Devices are to improve the quality, safety, and reliability of medical devices, and to implement risk management during the entire lifecycle of medical devices.
The goals were set to streamline Chinese market access for foreign manufacturers, establish a unique device identification (UDI) system for medical devices, optimize the clinical trial management system, and set up the process to enforce and penalize noncompliance with requirements, etc.
The new version of Regulations on the Supervision and Administration of Medical Devices offers general and highest-level regulations on medical devices. In early 2021, China NMPA announced the working plan to revise another six relative regulations to support the successful implementation of the new regulations. The six regulations cover the process from medical device registration, quality control, productions and aftermarket regulations, etc. We will watch for further announcements as to when the new version of the documents is released.
The specific regulations under review are titled:
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Measures for the Administration of Registration of Medical Devices
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Measures for the Administration of Registration of In-Vitro Diagnostic Reagents
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Measures for Supervision and Administration of Medical Device Production
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Measures for Supervision and Administration of Medical Device Operation
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Measures for the Supervision and Administration of Use Quality of Medical Devices
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Measures for the Administration of Medical Device Adverse Event Monitoring and Re-evaluation
After NMPA finishes the revision on these regulations, the administration will have comprehensive guidance for medical devices.
As an essential component of medical devices, the sterile barrier system ensures the safety of terminally sterilized medical devices. The regulatory requirements of China medical packaging for terminally sterilized medical devices will be updated and improved, especially for risk management of the lifecycle of the whole device, as required by the new version of Regulations on the Supervision and Administration of Medical Devices.
China’s medical device packaging standards are continually developed to meet regulatory requirements. Thus, we believe that, after the new regulations implemented after June 1, 2021, several standards of medical device packaging can be revised or updated to comply with the new regulations.
The following four China medical packaging standard series will be reviewed in the future.
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National Standard GB/T 19633 series (Part 1~2, identical to ISO 11607) Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems, Part 2: Validation requirements for forming, sealing and assembly processes.
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Sectoral Standard YY/T 0698 series (Part 1~10, converted from EN868 series) Packaging materials for terminally sterilized medical devices — Requirements and test methods.
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Sectoral Standard YY/T 0681 series (Part 1~18, converted from ASTM related standards) Test methods for sterile medical device package.
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Sectoral Standard YY/T 0466 series (Part 1 ~2, identical to ISO 15223) Medical devices — Symbols to be used with medical device labels, labeling and information to be supplied.
As we know, ISO TC 198/WG7 team is working on Amendment of ISO 11607 to add details for risk management over the life cycle of medical packaging. The SAC/TC 200 team (Chinese mirror group of ISO TC 198) will adopt it into the China National Standard GB/T 19633 accordingly, which will provide the detailed guidance to help industry comply with the new requirements in Regulations on the Supervision and Administration of Medical Devices, etc.
I believe that in the future, China’s regulations, standards, and test methods will be more streamlined with international regulations and standards.
For more details on Regulations on the Supervision and Administration of Medical Devices, please read more here. (Chinese version only available).
