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. […]

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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. Factors such […]

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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 […]

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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. The information in this article was last updated […]

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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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Globally many consider herbs and botanicals to be natural and therefore healthier and gentler than conventional drugs. Currently, 30% of prescription drugs are herbal and botanical drugs. Herbals and botanicals are used for the treatment and improvement of health and well-being. Many countries use herbal and botanical drugs traditionally for many years to generations. The […]

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Sourcing or importing the IMPs and their supportive products is a challenging process for many researchers and this is more prominent with the countries like China and Japan where understanding the regulations is difficult due to the language barriers and rapid changing norms for making imports.  Many key players in logistics are unclear about the […]

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Getting the study drug at the right time is challenging for any clinical trial, and this is more prominent with multi-regional clinical trials. To import and have the IMPs and ancillaries at the clinical trial sites in time, the sponsors need to have the right people, processes, facilities, and technology in place. Note: This article […]

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As clinical trials have become increasingly global and complex, ancillaries have grown in volume, type, and expectations. The clinical trials supplies market is projected to reach  USD 2.5 billion by 2025 owing to the logistics services with the increasing number of clinical trials involving temperature-sensitive drugs. Currently, North America is the largest market for clinical […]

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The conduct of clinical trials is a critical process. Along with resource hiring, it also requires materials for different activities. Some of these materials can be investigational products. But, a vast number of products could be non-investigational products necessary for the conduct of clinical trials. It becomes critical to plan for procurement or import of […]

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