To determine if your medical device requires a clinical trial in China, consult the National Medical Products Administration (NMPA) guidelines. Check the device classification and refer to the NMPA’s “Clinical Evaluation Exemption List.” If not exempt, a clinical trial is likely required.... Read More
Registering a medical device in China involves classification determination, appointing a local agent, preparing and submitting technical documentation, conducting type testing, and for risky devices, a clinical evaluation report or local clinical study. The National Medical Products Administration (NMPA) reviews the application,... Read More
Obtaining a Quality System Documentation (QSD) certificate in Taiwan enhances a company’s professional credibility, ensures compliance with local regulatory standards, and improves product quality and safety. The QSD plus device dossier submission is required for device registration in Taiwan. The QSD certificate... Read More
Korea Good Manufacturing Practices (KGMP) are regulatory standards set by Korea’s Ministry of Food and Drug Safety (MFDS) to ensure the quality, safety, and efficacy of pharmaceutical and medical device manufacturing. KGMP guidelines cover production processes, quality control, facility management, and documentation... Read More
To submit a Drug Master File (DMF) in Korea, prepare the required documentation, including detailed information on Active Pharmaceutical Ingredients (APIs), Excipients, or Packaging Materials. Submit the DMF to the Ministry of Food and Drug Safety (MFDS) through their electronic submission system.... Read More
Medical device registration in Korea involves obtaining approval from the Ministry of Food and Drug Safety (MFDS). This process ensures that medical devices meet safety, efficacy, and quality standards before being marketed. It includes documentation, clinical trials, and compliance with Korean regulations... Read More
In China, Drug Master Files (DMFs) are categorized into three types: Active Pharmaceutical Ingredients (APIs), Excipients, and Packaging Materials. These DMFs ensure regulatory compliance and quality control for pharmaceutical products, facilitating the approval process by providing detailed information on manufacturing, quality, and... Read More
The National Medical Products Administration (NMPA) oversees the regulation and approval of medical device clinical trials in China. It ensures compliance with safety and efficacy standards, reviews trial protocols, grants necessary approvals, and monitors post-market surveillance to protect public health and ensure... Read More
In China, medical devices are classified into three categories based on risk levels: Class I (low risk), Class II (moderate risk), and Class III (high risk). The National Medical Products Administration (NMPA) oversees the classification, registration, and regulation to ensure safety and... Read More
A Quality System Documentation (QSD) certificate in Taiwan is an official document issued by regulatory authorities, confirming that a company’s quality management system complies with local standards and regulations. It is essential for businesses, particularly in the medical device and pharmaceutical industries,... Read More