In late March, the Philippines FDA (PFDA) has extended the registration date for Class B,C and D medical device registration for devices that were not already on the registrable medical device list. Now, these medical devices do not need to be registered until... Read More
Singapore is an important drug market in Asia. Not because of the market size which is rather small, but because it is the second best overall healthcare market in Asia, after Japan. Getting drug approval and being successful in the Singapore market... Read More
Singapore has the second best healthcare system in Asia after Japan. Thus, as a healthcare leader, Singapore constantly updates its regulations to adapt to new technologies. Singapore is working towards enhancing the cybersecurity and regulatory compliance of medical devices. With the increasing... Read More
According to Singapore’s Regulation 23, when a drug company wants to register a new drug, the Health Sciences Authority (HSA) needs to determine if there is a patent in force. According to the Singapore’s Patent Act 1994, the HSA requires the drug... Read More
Submission of applications to the Japanese authority now mandates usability engineering. The international standard IEC 62366-1, governing usability engineering in medical device development, transitioned into a JIS standard in 2019 and was updated as JIS T62366-1:2022 in February 2022. JIS T 62366-1... Read More
Japan’s PMDA will open its first overseas office in Bangkok in 2024 or at the latest by March 2025. The new PMDA office will interact with Southeast Asian countries and hopefully improve their knowledge of Japanese requirements. China removes tariffs on 62... Read More
In late October, the Singapore HSA requested that relevant players provide feedback on their draft Guidance for Device Clinical Evaluation. Before medical device registration in Singapore, a medical device must show clinical evidence aligning with the appropriate – Essential Principles of Safety... Read More
In October, Singapore plans on starting a 90-day trial to determine the cybersecurity risk of medical devices. This is a joint effort between Singapore’s MOH, the Cyber Security Agency and the National Health Technology Agency (Synapxe). The fear is that some devices... Read More
A recent report by Bain & Company and APACMed (a MedTech trade association located in Singapore) has issued a report on Asian MedTech companies’ growing appetite for ESG initiatives. According to this report, the Asia region has doubled its ESG policies compared... 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