To encourage foreign investment into China and promote medical device localization, China's health authority has implemented the Production of Imported Medical Devices in China (Order No.104 2020) to simplify the registration process for companies who intend to transfer the approved imported device manufacturing sites overseas to mainland China.
Three years up to now, some companies have gained successful experience with this option. This blog would like to share practical navigation tips for companies exploring this route on strategy mapping or already in the implementation phase.
- Application scope
This favourable policy is applied to Class II and Class III medical devices and IVDs, which are manufactured in China directly through their foreign-invested parent company. The intended devices have already been approved in China under the imported registration route and remain unchanged when transferred to the Chinese production site.
- Registration applicant
The applicant shall be a foreign-invested entity established in China whose direct parent company (out of China) holds an imported medical device certificate. The imported device certificate shall still be valid.
- Product Specification
The intended domestic devices shall comply with the approved imported medical devices certificate and its technical specifications. No design, primary manufacturing process, or raw material change is allowed. This is a hot debate topic. In many scenarios, the definition of the main manufacturing process may vary; the capital equipment may not always be available in China, or the raw material may be restricted to supply to the Chinese market. In other cases, the intended product to be made in China may involve reduced models, accessories, or configurations.
- Technical document (TD) requirements
A simplified TD checklist is applied for such domestic submissions. Some documents may submit the original documents approved under the imported device application route. Such as the product summary, research information, clinical evaluation, risk assessment plan and report, IVD reagents product summary, key raw material study (when applicable), primary production process, analytical performance assessment, positive value or reference interval data, and stability study.
- Approval process
The review and approval process are the same as all other domestic products. The duplicated documents mentioned in point 4 may save the manufacturer's preparation time and not impact the total technical review time from the authority aspect. In addition, if the connected imported device has been approved a long time ago, there may be gaps between the old and current technical documentation requirements to be closed first.
- Registration certificate
The product certificate is valid for five years. The registration number of the connected imported product will be listed in the remark column of the domestic registration certificate.
- Quality Management System
The domestic manufacturer shall ensure that the device's major production processes, key raw materials, and manufacturing processes do not change. No product design change shall be adopted, and the product's initial safety, performance, and effectiveness shall still be achieved. A comparison assessment report of the implemented quality management system in China vs. its foreign site shall be prepared and prove the two systems are equivalent. The Chinese health authority NMPA will perform a comprehensive quality system inspection on the Chinese production site once the application is submitted. The inspection may focus on the equivalence between domestic and foreign quality management systems, the traceability, and whether changes in the system may generate new risks or further trigger product changes. The transfer is a production transfer and involves the design history file transfer to the local site.
- Post-market surveillance
Domestic manufacturers/applicants shall apply for a production permit by conforming to the China Measures for Supervision and Administration of Medical Device Production. They need to strengthen the quality management of medical devices throughout their life cycle and maintain the quality management system after approval to ensure its effective operation according to China GMP requirements.
- MAH
MAH scheme does not apply to No.104. It means the local transferred production shall not contract the manufacturing to third parties.
- Other aspects
The policy also applies to the products originating from Hong Kong, Macao, and Taiwan areas that have obtained medical device registration certificates under imported routes.
Please contact us if you have questions about understanding, interpreting, or implementing Order No.104.