Li Li, commissioner of China's National Medical Products Administration (NMPA), led a delegation to Vietnam and Thailand from 11 to 15 November to enhance bilateral collaboration in pharmaceutical regulation. During the visit, Li signed memorandums of understanding (MoUs) with health authorities in both countries.
In April, the recent release of the 2024 medical device classification encompasses 223 results, including 93 products related to In Vitro Diagnostics (IVD). Among these, 27 IVD-related products are suggested for Class III medical device management, 45 for Class II, and 14 for Class I.
Johnson & Johnson's (JNJ.N), opens new tab first-quarter revenue missed Wall Street estimates for medical devices on Tuesday and sales of its blockbuster psoriasis drug Stelara came in lower than expected as the company prepares for its loss of exclusivity in the U.S.
From 1 January to 31 December 2023, China’s NMPA accepted a total of 13,260 applications for the first registration, renewal of registration and change of registration of medical devices in accordance with its duties, an increase of 25.4% compared with 2022.
A new UK industry body designed to help medical device regulators navigate the new legal landscape of a post-Brexit Britain has launched with backing from 11 companies.
The US Food and Drug Administration on Tuesday issued a letter to medical device manufacturers and sponsors of device studies warning them to independently verify performance test results before submitting them to the agency due to concerns about fraudulent results.
Recently, the internationally renowned Top Employers Institute released the "China Top Employers 2024" list.
Abbott Laboratories (NYSE:ABT) posted higher sales of $10.24 billion in the fourth quarter, despite continued soft demand for the company’s Covid-19 testing equipment, beating the consensus of $10.18 billion.
The European Commission (EC) has proposed an extension of the transition period for the IVDR, aiming to maintain the availability of essential healthcare products and ensure patient care.
The total number of first-time registrations of Class II and III medical devices in 2023 was 14,942, a decrease of 129 registrations compared with that of 2022.
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