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NMPA Resumes Overseas On-Site Inspections After COVID-19 Pause

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The NMPA released the results of two overseas inspections on October 8, 2024, which revealed noncompliance in two South Korean manufacturers. This marked the resumption of overseas on-site inspections of imported medical devices, following a halt in 2020 due to the COVID-19 pandemic.

Inspection Findings and Actions

The NMPA conducted inspections of two Korean aesthetic implant companies, SDM Co., Ltd. and Search Medical Co., Ltd. The focus was on their Class III medical devices, specifically dental implants and e-PTFE facial implants.

The inspection found that SDM Co., Ltd. had significant deficiencies in its quality management system, including issues with document management, design and development, production management, and quality control. These lapses raised concerns about the safety and quality of their products.

Similarly, the inspection of Search Medical Co., Ltd. uncovered serious deficiencies in areas such as institutional and personnel management, equipment management, document management and design and development, also leading to quality and safety risks.

As a result of these findings, the NMPA has suspended the import, distribution, and use of the affected products from both companies, effective immediately, in accordance with the Decree 739 “Regulation on the Supervision and Management of Medical Devices”.

Guideline for Overseas Inspections

The NMPA first introduced its “Administrative Regulation of Drug and Medical Device Overseas Inspection” in December 2018. These regulation outlines the process for conducting risk-based inspections of overseas medical device manufacturers and R&D facilities. The Center for Food and Drug Inspection (CFDI) of the NMPA is responsible for organizing and implementing these inspections, with support from relevant departments.

Manufacturers are required to comply with several key steps when notified of an overseas inspection:

  • Submit a “Letter of Authorization” and a “Basic Information Table of Overseas Inspecting Products” to CFDI within 20 working days.
  • Provide key documents related to the inspected site and other necessary materials within 40 working days after receiving the inspection notice.

Other important points include:

  • Inspections cover not only manufacturing sites but also R&D locations abroad.
  • Delaying, obstructing, restricting, or refusing the inspection will result in an automatic failure.
  • If serious quality risks are identified, NMPA will take immediate risk control actions.
  • CFDI can access and inspect technical documents with cryptographic security and include them in the inspection records.
  • Companies must maintain normal operating conditions during the inspection, providing access to relevant equipment, dynamic manufacturing processes, documents, records, and electronic data as requested.
  • If necessary, CFDI may sample and seal products, and the manufacturer must ensure proper packaging and transportation to avoid affecting sample quality.

Compliance and Future Considerations

The regulation clarifies the overseas inspection process, defining the roles and responsibilities of both the NMPA and overseas Marketing Authorization Holders (MAH). Given the strict requirements, overseas MAHs must thoroughly review their R&D and manufacturing processes, ensuring all documentation and equipment meet the necessary standards.

Additionally, overseas MAHs have the option to register as domestic MAHs in China, which would allow their medical devices to be classified as domestic products, offering a potential path to smoother market access.

For details on the noncompliance of Medtronic, Becton Dickinson, Boston Scientific, B. Braun, Bausch & Lomb, and Varian identified during the NMPA’s overseas inspections, please click HERE

For our comprehensive review of the “Made in China” policy, please visit HERE

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