Are Overseas Clinical Studies Accepted for Drug Registration in Singapore? a Are Overseas Manufacturers Subject To Korea Medical Device Registration Requirements? a Are Packaging And Labeling Controls Evaluated During Drug Quality Audits In Japan? a Are Pharmacovigilance Requirements Part of Drug ...
In South Korea, medical devices are categorized into four classes based on their level of risk, and procedures vary according to the class. Class I:Registration Class II: Certification Class III and Class IV: Approval from the MFDS For medical devices classified as Class II, Cl...
and revise regulations such as “Medical Device Registration Management Measures”, “In Vitro Diagnostic Reagent Registration Management Measures”. Up to now, there are total of 1758 currently valid medical device standards, including 226 national standards and 1532 industry standards; 397 mandatory ...
Qualtech is an international medical device consulting firm operating in Asia, North America, and EU. With a focus on Regulation, Market Access, and Clinical Trials.
China Medical Device Registrations 2023 Annual Report has been issued by the National Medical Products Administration (NMPA). Below we share some of the highlights. Applications and approvals in 2023 In 2023, the NMPA received a total of 13,260 applications for initial registrations, registration re...
Country and eligible for expedited review in most countries. As the NMPA continues to build out their standards and align with global expectations, this is expected to change, significantly benefiting local Chinese manufacturers and early market entrants seeking medical device registration in Southeast ...
Asia Actualwith questions or a request for support in Thailand. Asia Actual has a fully licensed offices in Bangkok staffed by experienced, bi-lingual regulatory and commercial professionals to offer medical device registration, independent license holding, importing and sales support services in ...
Companies without a physical location in South Korea must appoint a Korea License Holder (KLH) to coordinate the registration of their medical device with the Ministry of Food and Drug Safety (MFDS). The KLH controls the device registration and helps to manage compliance with Korea Good Manufactur...
Medical device registrations China 2022 Annual Report was issued by the NMPA (National Medical Products Administration) on February 8, 2023. In 2022, the NMPA received a total of 10,571 applications for the initial registration, registration renewals and changes in licensing items of Class III (Do...
The Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food and Drug Administration (KFDA), is the chief governmental body responsible for overseeing medical device and pharmaceutical registration, manufacturing, and distribution in South Korea. The MFDS is tasked with establishing...