The Indonesian medical devices market is one of the largest in Southeast Asia and continues to grow at an accelerating pace as a result of the country’s population growth, increased demand for sophisticated medical technologies, and improved healthcare delivery systems. Indonesia’s regulation... Read More
Indonesia requires most imported foreign products to meet its strict Halal requirements. The deadline for meeting Halal requirements has recently been extended. Different product categories have new certification deadlines. For our readers, these deadline extensions are important – 1. October 17, 2026,... Read More
From July 14, 2025, Singapore’s Health Sciences Authority (HSA) will enforce a revised version of the guidance document GN-21 to streamline medical device change reporting. Low-risk changes such as label designs, new barcodes, and supplier changes do not need to be reported.... Read More
Introduction Quality, safety, and efficacy are of the utmost importance for drug products. A vital part in achieving this is having a Drug Master File (DMF). A DMF is a confidential submission to a health authority to provide detailed information about the... Read More
Recently, The Asia Pacific Medical Technology Association (APACMed) released their position paper titled “Risk-based Change Management for Registered Medical Devices.” As noted in this paper, some Asian countries utilize risk-based methods for device changes, while others require change submissions no matter what... Read More
In an effort to improve the quality of medical devices distributed in Indonesia, the Indonesian MOH has put in place stricter guidelines. According to the new Circular Letter 03, starting on July 1, 2024, it will now be required that Indonesian medical... Read More
In late July, Indonesia’s government announced GR 28 which is similar to the Indonesian Health Omnibus Law, but with more detailed explanations. This new regulation covers a number of topics. First, it states that the National Health Information System can use data... Read More
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
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
Over the last 20 years, China’s drug business has seen tremendous growth. Western drug companies have heavily relied on China for drug products, drug substances, R&D, clinical trials, etc. However, now with increased geo-political friction between the US and China, more Western... Read More