In an effort to streamline and modernize its medical device regulations, Vietnam has recently implemented significant updates, aiming to enhance efficiency while ensuring the safety and efficacy of medical devices. Two key developments, Circular 10/2023/TT-BY and Decree #07 mark, substantial shifts in... 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
Japan’s medical device market is the third largest medical device market in the world, after the US and China. While it is a highly competitive market, unique products with good value propositions can be very successful there. While in the past Japan... Read More
As mentioned last year in our news brief, China initiated a significant corruption crackdown in 2023. This crackdown was escalated again late last year when China’s National People’s Congress promulgated the 12th amendment to its criminal code. Starting last month (March), penalties... Read More
In Indonesia, the Goods and Services Procurement Policy Agency, is responsible for an e-Catalogue that allows the government to purchase a variety of needed products. This is an online Indonesia government language procurement platform. The e-Catalogue in Indonesia was initially set up... Read More
Most drug and medical device executives know that getting Human Genetic Resources (HGR) from China is not an easy task. However, over the last year, China has implemented changes to make this a somewhat easier process. For example, data can be transferred... Read More
On March 6, 2024, Malaysia issued Medical Device Exemption Order 2024, superseding the previous Exemption Order from 2016. This regulatory overhaul introduces an expanded framework for the exemption of certain medical devices from the registration mandate under the Medical Device Act 2012. The... Read More
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
IVDs, drugs and medical devices have different reimbursement pathways in Japan. Normally, for all these paths, a reimbursement application is submitted after product approval. Reimbursement is then normally determined within 3-6 months. However, the MHLW is allowing some companies to have a pre-reimbursement meeting. For... Read More
Starting February 14, 2024, the Thai FDA has enhanced its medical device registration requirements. Prior to this new regulation, medical devices generally only required a partial ASEAN Common Submission Dossier Template (CSDT), but now a full CSDT is required. The Thai FDA... Read More