Regulatory affairs and translation play a crucial role in the pharmaceutical industry. Regulatory affairs refer to the processes and activities involved in ensuring that pharmaceutical products comply with the regulatory requirements of the relevant authorities. These requirements include safety, efficacy, and quality standards. Translation, on the other hand, refers to the accurate and timely translation […]
Read More →Translation plays a crucial role in facilitating accurate communication between participants, researchers, and sponsors in conducting clinical trials on a global scale. This can be a challenging task, especially when language barriers come into play. Clinical trials are critical for developing new drugs, medical devices, and treatments. These trials aim to test the safety, efficacy, […]
Read More →Medical device regulations vary from country to country, and this is not different in Japan. To register your medical device in Japan, you need to look for these top 6 considerations to make your registration process easy. Japan is a global economic powerhouse with one of the largest medical device markets. In terms of US […]
Read More →Myanmar offers tremendous business opportunities for U.S. exports of medical device, equipment and supplies. Myanmar’s private health sector depends on imported medical equipment and supplies to meet the increasing local demand for high-quality health services. In Myanmar, there are no specific laws governing medical & IVD devices,and laboratory diagnostic testing in Myanmar. Such matters generally […]
Read More →Myanmar depends on imports for nutraceutical supplements and over-the-counter products. The nutraceutical supplements market in Myanmar is very competitive. Pharmaceutical spending is growing at double-digit growth, and researchers expect it to reach USD 1.1 billion valuations by 2023. Considering the huge opportunities in Mynamar, many companies are showing interest in registering and marketing their products […]
Read More →There is a growing demand for medical devices in Malaysia, and overseas manufacturers are showing interest in registering and marketing their medical devices in Malaysia. The Medical Device Authority (MDA), the regulatory body for the medical device industry in Malaysia, projects that the market will grow at a 16.1% annual rate to reach US$1.4 billion. […]
Read More →According to a recent analysis by an agency, the Malaysian pharmaceutical market is anticipated to increase from $2.3 billion in 2015 to $4.6 billion by 2022, reflecting a 9.5% CAGR. Seeing this demand many manufacturers are showing interest in registering their drug products in Malaysia. This information was last updated in March, 2023. The demand […]
Read More →Japan has the same regulations and practices for nutraceuticals, food, and beverage goods as any other nation. Legitimate safety regulations, regulatory protectionism, and customs taxes present manufacturers with significant obstacles when they attempt to enter the market. The Ministry of Health, Labour, and Welfare (MHLW) and Consumer Affairs Agency (CAA) are in charge of enforcing the Food […]
Read More →The medical device market has grown significantly in recent years. Recent estimates suggest that the global market for medical devices will reach $612.7 billion by 2025. However, competition is fierce, and medical device companies of all sizes have questions about where and how to register their device. So, let’s see where and how to market […]
Read More →The Medical Device Control Division (MDCO) from the office of the Food and Drug Administration (FDA) in Thailand (also known as the Thai FDA) oversees Medical device regulations. Recently the Thai FDA has made many changes in regulatory requirements and the approval process for medical devices. This article was last updated in March, 2023. Medical […]
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