Katherine Wang

1 month ago | lexology.com | Katherine Wang

The 27th International Medical Device Regulators Forum (IMDRF) conference, held this week in Japan, gathered regulators and industry representatives to discuss the organization’s five-year strategic plan. Stakeholders recommended that the IMDRF should focus on initiatives that foster regulatory efficiency, harmonization and convergence. Key areas include standardized submission format, post-approval change management, post-market surveillance and electronic IFU.

1 month ago | lexology.com | Geoffrey Lin |Katherine Wang |David McIntosh |Georgina Jones Suzuki |Manish Namireddy

Amid increasing economic tensions with the United States, China recently announced that it would ban Illumina, a U.S.-based company and the world’s leading producer of gene-sequencing machines, from importing its gene sequencers into the country.1 The Chinese government’s decision to do so is one of several retaliatory measures China has taken against American companies in response to the United States’ decision to impose additional tariffs on the country.

2 months ago | mdpi.com | Katherine Wang |Jitesh Joshi |Youngjun Cho

All articles published by MDPI are made immediately available worldwide under an open access license. No special permission is required to reuse all or part of the article published by MDPI, including figures and tables. For articles published under an open access Creative Common CC BY license, any part of the article may be reused without permission provided that the original article is clearly cited. For more information, please refer to https://www.mdpi.com/openaccess.

Oct 28, 2024 | mondaq.com | Katherine Wang

On October 21, 2024, the China National Medical Products Administration (NMPA) released a pilot plan that allows non-end-to-end manufacturing of biologics. The NMPA has a longstanding position to require an end-to-end production of biologics in a single manufacturing location. In other words, the drug substance and the drug product shall in principle be produced at the same manufacturing facility.

Sep 1, 2024 | lexology.com | Katherine Wang

China’s National Medical Products Administration (NMPA) is soliciting public comments on the draft Medical Device Administrative Law (MDAL), the first statute of its kind, until September 28, 2024. The draft MDAL has three key points:The introduction of incentives to launching new products in China;Greater importance to compliance with China’s compulsory product standards; andIncreased liability of the local legal deputy of foreign marketing authorizations holders. 1.