In our previous blog post, we explained the China NMPA inspection process and steps that an inspected site needs to take to prepare for the inspection. The requirements for the inspection process were taken from Announcement No. 101 on Issuing the Administrative Measures for Overseas Inspections of Drugs and Medical Device announced by NMPA on December 26, 2018.
In this series, we will provide valuable insights and recommendations for foreign manufacturers on effectively preparing for NMPA inspections.
Preparing for an NMPA inspection can be daunting for medical device manufacturers. However, with proper preparation and planning, manufacturers can increase the likelihood of a successful inspection. One key element of this preparation is conducting a series of preparation activities to identify and address potential issues prior to the actual inspection.
The following are important steps to take during the pre-inspection preparation:
- Understand the regulatory requirements: Before preparing for an NMPA inspection, it's important to understand the regulatory requirements for medical devices in China clearly. This includes knowledge of the applicable regulations, guidelines, and standards and incorporating the applicable requirements into the Quality Management System (QMS). In particular, the product technical requirement (PTR) shall be understood and incorporated into the product validation and final release. The focus shall be on the products in the registration scope or those marketed in China.
- Conduct an internal audit: Prior to the inspection, manufacturers should conduct an internal audit of their QMS and processes according to the applicable regulations (e.g., China GMP) and standards. This can help identify any deficiencies or gaps in the system that must be addressed before the inspection. It is important to ensure that the audit is conducted by qualified personnel and that the audit report is comprehensive and well-documented.
- Review documentation: Manufacturers should review all relevant documentation related to their medical device, including the technical file and any other regulatory documentation. It is important to ensure that all documentation is up-to-date and complete.
It is recommended that manufacturers have all relevant documentation related to their medical devices available in Chinese. This includes technical files, labeling, and other regulatory documentation. This is important because NMPA inspectors may not be fluent in English and may not be able to understand English-language documents. Furthermore, it is important to ensure that the translation of the documents is accurate and comprehensive. This can be done by using a professional translation service or by working with a regulatory consultant fluent in English and Chinese. - Conduct a mock inspection: A mock inspection can help manufacturers identify potential issues and prepare for the actual inspection. This can include simulating the inspection process and having experienced professionals conduct a review of the facility and documentation. The results of the mock inspection can be used to identify areas that need improvement or to implement corrective actions.
- Train personnel: All personnel involved in the manufacturing, testing, and quality control processes should be trained on the inspection process and their role in ensuring compliance. This can include providing training on documentation management, quality control processes, and risk management. It is important to ensure that personnel is also trained on the applicable regulatory requirements in China, for instance, GMP, GCP, and GLP.
- Implement corrective actions: Any issues identified during the internal audit, documentation review, or mock inspection should be addressed promptly. This can include implementing corrective actions or updating documentation to ensure compliance with NMPA regulations.
- Translators arrangement: We recommend having a professional translator present during the NMPA inspection. This is especially important if the inspectors are not fluent in English and the documentation is unavailable in Chinese, as mentioned above. Having a translator present can help ensure that the inspection process goes smoothly and that all communication between the manufacturer and the inspectors is clear and accurate. The translator can also help clarify misunderstandings or answer questions the manufacturer may need help answering in Chinese. It is important to note that the translator should be a professional experienced in medical device regulations and terminology. Some companies may opt to assign RA/QA personnel with proficiency in both Chinese and English as translators during NMPA inspections. It is important to note that the role of a translator is not limited to literal translation but also requires a deep understanding of the underlying questions and the ability to effectively address and clarify any concerns.
To sum up, while preparing for an NMPA inspection can be difficult, it is essential to guarantee compliance with NMPA regulations for medical devices. Manufacturers can improve their chances of passing the inspection by undertaking a comprehensive preparation, which entails understanding the regulations, performing an internal audit, reviewing documentation, conducting a mock inspection, training personnel, and so on. By following these steps, manufacturers can consistently increase their chance of being ready for NMPA inspection.
In the next blog post, we'll take a closer look at Announcement No. 50 of 2022 Guidelines for the Verification of the Quality Management System for Medical Device Registration and what it means for manufacturers. We will explore the key stringent regulatory requirements and considerations for QMS verification during registration.
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 MedicalDevice 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 need subject-matter expertise contact us.