Asia
Oman’s Directorate of the General Pharmaceutical affair and Drug Control (DGP&DC) has published draft guidance dedicated to medical devices bundling/grouping criteria. The document provides an overview of existing legislation and clarifications regarding the...
Asia
The Directorate General of Pharmaceutical Affairs and Drug Control, the country’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the regulatory requirements related to the registration of high-risk medical...
Asia
The Philippines Food and Drug Administration (FDA) has published a circular implementing the interim guidelines describing the conduct of licensing inspections for radiation facilities. In the case of any discrepancies, the provisions of the new circular shall...
Asia
The Taiwan Food and Drug Administration (FDA) has published several draft guidance documents dedicated to the post-market activities related to medical devices marketed in Taiwan. In particular, the documents are covering the aspects related to the adverse events...
Asia
The Medical Device Authority (MDA), a branch of the Ministry of Health Malaysia responsible for medical device regulation, issued guidance documents dedicated to handling complaints, and mandatory problem reporting. Regulatory Background The Malaysian regulating...
Asia
The Ministry of Food and Drug Safety (MFDS), the South Korean authority responsible for medical devices regulation, published a brochure providing an overview of the existing regulatory framework. The document covers the most important aspects related to medical...
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