Korea recognizes international medical device standards through its Ministry of Food and Drug Safety (MFDS). The MFDS adopts and aligns with International Standards Organization (ISO) norms and International Electrotechnical Commission (IEC) standards. Harmonization with these global standards facilitates international trade and ensures... Read More
In China, pharmaceutical plants must undergo Good Manufacturing Practice (GMP) re-certification every five years. This ensures continuous compliance with evolving standards. The National Medical Products Administration (NMPA) conducts these inspections, evaluating facilities, processes, and quality control measures to guarantee the safety and... Read More
Yes, China accepts international clinical trials for pharmaceutical registration. The National Medical Products Administration (NMPA) has implemented reforms, allowing data from overseas trials to support drug approvals. However, the data must comply with Chinese regulatory requirements and may sometimes necessitate additional local... Read More
The process for Vietnam drug registration involves submitting an application to the Drug Administration of Vietnam (DAV), including comprehensive data on the drug’s quality, safety, and efficacy. DAV evaluates the submission and conducts testing. Once approved, the drug can be marketed and... Read More
The agency responsible for managing medical device approvals in Indonesia is the National Agency of Drug and Food Control, known locally as “Badan Pengawas Obat dan Makanan” or BPOM. They regulate, evaluate, and ensure the safety and efficacy of medical devices for... Read More
In Korea, a medical device is defined as an instrument, apparatus, implant, software, or other related articles that are used for diagnosis, prevention, monitoring, treatment, or alleviation of diseases. These devices are subject to regulatory oversight by the Korean Ministry of Food... Read More
The drug registration procedure in Korea involves submitting an application to the Ministry of Food and Drug Safety (MFDS), including clinical trial data, safety information, and manufacturing details. MFDS reviews the application for efficacy, safety, and quality, followed by inspections. If approved,... Read More
In Malaysia, the device registration process‘s duration varies based on the device and regulatory requirements. Typically, for most devices, the process can take anywhere from 3 to 12 months. However, it’s crucial to check specific timelines with Malaysia’s Medical Device Authority for... Read More
In Malaysia, the National Pharmaceutical Regulatory Agency (NPRA), under the Ministry of Health, is responsible for ensuring the safety, efficacy, and quality of drugs. They evaluate and approve pharmaceuticals, ensuring that medicines available to the public meet stringent standards. This agency ensures... Read More
China’s Good Clinical Practice (GCP) has evolved to align closely with the International Council for Harmonisation (ICH) guidelines. Emphasizing scientific credibility, ethical standards, and patient safety, China’s regulatory adjustments signify its commitment to synchronize its pharmaceutical standards with international best practices, ensuring... Read More