Key Strategies for Successfully Passing NMPA Inspections for Medical Device Manufacturers

Part 5. Verification of the QMS for Medical Device Production (Manufacture) based on GMP (Good Manufacturing Practice for Medical Device) Requirements (CFDA order No. 64 2014)

In our previous blog post, we highlighted the importance of understanding and complying with the regulatory requirements outlined in the NMPA Guidelines for Inspection of the Quality Management System (QMS) for Medical Device Registration (2022 No. 50) for the inspection of the QMS for medical device registration, covering various aspects such as QMS principles, personnel, facilities, documentation, design and development, purchasing, production, quality control, outsourced production, and product authenticity. This blog aims to explore the well-known GMP (Good Manufacturing Practice for Medical Devices) Requirements (CFDA Order No. 64 2014) and provide some insights into the differences between ISO 13485 and the Chinese GMP requirements.

In China, the ISO 13485:2016 standard, which is internationally harmonized, has been incorporated into a recommended industrial standard known as YY / T 0287-2017. Importantly, it's worth noting that compliance with YY / T 0287-2017 is not mandatory. Instead, the mandatory QMS regulation in China, which serves as the basis for overseas on-site audits, is the "Good Manufacture Practice for Medical Devices." (China GMP) This regulation covers various aspects, including the design, manufacturing, sales, and after-sale services of medical devices intended for the Chinese market (Table 1).

Table 1. Notice No. 64 Good Manufacturing Practice for Medical Devices

As it was already mentioned in our previous blog, for manufacturers of the implantable, sterile medical devices, independent software, custom dentures, and in-vitro diagnostic reagents the following additional China GMP annexes shall be considered:

• Implantable devices: Appendix of Implantable Medical Device to Good Manufacturing Practice for Medical Devices.
• Sterile medical devices: Appendix of Sterile Medical Devices of Good Manufacturing Practice for Medical Devices.
• In-vitro diagnostic reagents: Appendix of Good Manufacturing Practices on In Vitro Diagnostic Reagents.
• Independent software:  Appendix: Independent Software.
• Custom dentures: Appendix of the Good Manufacturing Practice for Medical Devices for Custom-made Dentures.

In most cases, the requirements specified in the China GMP align well with both ISO 13485 and Good Manufacturing Practices (GMP). It's important to highlight that the on-site audit is carried out selectively, especially for initial applications for the registration of imported medical devices. In such cases, the National Medical Products Administration (NMPA) in China will acknowledge the QMS qualification issued by the foreign applicants' home country.

The NMPA recognizes an ISO 13485 certificate for overseas manufacturers as sufficient evidence of the manufacturer's qualifications. However, it's essential to give particular attention to any China-specific requirements that must be integrated into the QMS to ensure compliance with regulations when marketing medical devices in China. This is similar to many other countries with additional regulatory requirements next to or on top of ISO 13485.It's noteworthy to point out that all local Chinese medical device manufacturers are required to undergo on-site QMS audits before they can submit applications for their products.

In contrast, most medical device manufacturers from overseas have not been subjected to on-site audits by the CFDA (China Food and Drug Administration), now - NMPA.

Currently, China has not expressed any intentions to participate in "Mutual Recognition Agreements" or accept audit reports issued by conformity assessment bodies from other countries. While in practice, on-site audits for overseas manufacturers are conducted selectively pre- or post-market, it remains the responsibility of these medical device manufacturers to adhere to Chinese regulations when they market their products in China.

Therefore, the importance of identifying and adhering to Chinese regulations should not be solely based on the "risk" of being chosen for an on-site audit overseas.

What portion of the additional requirements needs to be addressed to achieve compliance with China's GMP?

To determine the extent of additional requirements that must be met to align with China's GMP standards, the manufacturer, who has already implemented a QMS in accordance with the ISO 13485:2016 standard, needs to conduct a comprehensive gap analysis. This analysis involves a detailed examination of the existing QMS against the specific criteria and expectations set forth in China's GMP regulations. By doing so, the manufacturer can identify the areas where adjustments, enhancements, or additional measures are needed to ensure full compliance with China's GMP requirements.

The table below shows a selection of the requirements within each chapter of the ISO 13485:2016 standard versus similar requirements in China GMP and highlights the differences between the two QMS regulations.
Table 2. Differences between ISO 13485:2016 and China GMP

In summary, while there may be some overlapping requirements between China's GMP and ISO 13485:2016, it's important to recognize that China GMP introduces a host of new Quality Management System (QMS) requirements that manufacturers are obligated to adhere to. These new requirements encompass a wide spectrum of elements, ranging from product quality and safety to personnel health and operational practices. As such, manufacturers need to not only navigate the familiar territory where ISO 13485:2016 applies but also proactively address and integrate the novel elements introduced by China's GMP into their QMS to ensure comprehensive compliance.

Becoming curious about what the NMPA inspection process entails?

Read our blog series - 7 parts:

Part 1. China NMPA inspection types

Part 2. China NMPA inspection process

Part 3. Preparation for China NMPA inspection

Part 4. Verification of the QMS for Medical Device Registration

Part 5. Verification of the QMS for Medical Device Production

Part 6. Verification of the QMS for Medical Device Distribution

Part 7. China NMPA Inspection Results and Common Findings

If you need assistance with the preparation to upcoming NMPA inspection, mock-inspection, gap assessment of QMS compliance with China regulations or subject-matter expertise contact us.