With tensions between the US and China still very high, many Western medical companies are looking for alternative places to make their products. Medical companies have looked more aggressively to Vietnam and India as new manufacturing hubs over the last few years. Not... Read More
Beginning on October 1, 2024, drug companies submitting NDAs, GDAs, and minor variation applications in Singapore must also incorporate GMP Compliance Evidence for their drug substances. There is a grace period until September 30, 2024, but Singapore’s HSA recommends that drug substance... Read More
Despite the ongoing political frictions between the US and China, many Western pharmaceutical companies still rely heavily on Chinese drug companies for the production of APIs, excipients, and finished drug products. To source drug components and drugs from China, meeting Western GMP... Read More
India provides the world with many drug products and drug substances. To ensure high quality, the Union Health Ministry now requires that all state drug authorities gather data on all Indian pharmaceutical companies. The Indian central government wants to collect information on... Read More
Two weeks ago, India’s Union Cabinet, the top decision-making body in India, authorized a new medical device policy to increase its domestic device production. Currently, India only makes about 1% of the world’s medical devices and this new policy aims to increase... Read More
Recently, the President of Indonesia announced presidential regulation #6 requiring all drugs, biologics, and medical devices to meet Halal law. This law came into effect in mid-January. Medical products that do not have non-Halal components/materials and are made via a Halal manufacturing... Read More
Starting May 1, the China National Supervision Administration updated the 2014 Measures on the Supervision and Administration of Medical Devices Manufacturing. These measures put in effect more rigorous regulatory manufacturing requirements and increased the responsibilities of medical device manufacturers and third-party OEMs. While... Read More
Contact us to learn about how we can help you in the Chinese MedTech market. This article was first published on MedTech Intelligence. Everyone knows China has a large medical device market. Over the last 30 years and up until a few... Read More
Spotify: https://open.spotify.com/episode/61krNTBfW9nKHadjtOOIuT?si=zGlmcBWnTUKGYT7qXOo1XQ&dl_branch=1 Apple: https://podcasts.apple.com/us/podcast/project-medtech/id1513851432?i=1000527075358 Read More
Plans by China to create a free trade port in Hainan province, which have moved forward swiftly this year, bolster opportunities for the growth of the country’s pharmaceutical industry. They are also likely to lower prices on imports for Chinese consumers who... Read More