Combination products, which are innovative therapeutic and diagnostic products that combine drugs, devices, and/or biological products, are becoming increasingly prevalent in the healthcare industry. In China, the registration of these products is governed by specific Regulatory frameworks that help ensure their safety, efficacy, and quality.
Navigating the Regulatory landscape for medical device registration in China can be a complex process, especially for foreign manufacturers. One of the most critical steps in ensuring compliance with Chinese Regulatory requirements is the appointment of a China agent. This blog will provide a comprehensive guide on why you need a China agent, their key responsibilities, and the process of appointing them for medical device registration in China.
The Guidelines for Registration Review of Radio Frequency (RF) beauty devices in China is a consolidated document that guides registration applicants and technical review departments on how to prepare registration application materials for RF beauty devices.
These guidelines are meant specifically for RF beauty devices, which include devices used for skin treatment, fat reduction, and other cosmetic purposes; such devices use high-frequency current to act on the human body.
With the growing complexity and sophistication of medical device software, the Regulatory requirements for their registration are becoming increasingly stringent. In 2022, the National Medical Products Administration (NMPA), China introduced revised guidelines specifically addressing the registration process for medical device software. The guidelines provide a comprehensive overview of the Regulatory standards that manufacturers and developers must adhere to when registering their products in China.
A combination product is a therapeutic or diagnostic product that combines drugs, medical devices, and/or biological products. It combines at least two (02) of these product categories and sometimes even combines all three (03) categories. One of the key growth drivers for this market is the increasing prevalence of chronic diseases such as diabetes, cancer, and cardiovascular diseases. Combination products offer an innovative way of treating these diseases, as they can be delivered directly to the affected area, resulting in more effective treatment.
IVD devices are essential for healthcare professionals in providing accurate and timely diagnosis, monitoring, and treatment of diseases, leading to improved patient outcomes and better public health. IVD devices are classified into different classes based on their level of risk to the patient and the complexity of the device. The classification system for IVD devices varies depending on the region or country.
Artificial Intelligence (AI) has the potential to revolutionize the healthcare industry by improving the accuracy, efficiency, and speed of diagnosis and treatment. However, the development and deployment of AI medical devices also pose significant Regulatory challenges. In response, China's National Medical Products Administration (NMPA) has issued guidelines for registering and reviewing AI medical devices. This review will provide a comprehensive overview of these guidelines, their implications, and their potential impact on AI medical devices in China.
The Unique Device Identification (UDI) system is an international standard that assigns a unique code to each medical device to improve patient safety and streamline product tracking and recall. In China, the National Medical Products Administration (NMPA) has implemented UDI guidelines and regulations for medical devices to enhance safety and quality control.
Cybersecurity is a critical component of the designing, developing, and deploying medical devices. As cyberattacks can manipulate or destroy personal and sensitive patient data, Regulatory Agencies worldwide are now strengthening the Regulatory requirements to ensure medical device cybersecurity.
China has in place regulations for medical device cybersecurity that are designed to ensure the safety and privacy of patient information. The regulations apply to both domestic and foreign manufacturers of medical devices sold in China.
With the enactment of NMPA’s Regulations on the Supervision and Administration of Medical Devices - Order 739 in 2021, the medical device registration process in China has undergone substantial changes. The NMPA has implemented several process-related changes to streamline and improve the device registration process.
