Quality Management for Medical Products in the Other Asian Countries

Hong Kong, Indonesia, Malaysia, the Philippines, Singapore, Taiwan, Thailand, and Vietnam

Quality Assurance in Hong Kong, Taiwan, and ASEAN Countries

Asian countries such as Vietnam, Thailand, Malaysia, Indonesia, and the Philippines are generally low-cost centers for sourcing and manufacturing medical products. Quality systems in these less developed countries vary, so expert assistance is necessary to ensure that local manufacturers comply with quality standards. More developed and expensive Asian countries, such as Taiwan, Singapore, and Hong Kong, generally have much more developed quality systems; but they are also still in the process of enhancing their medical quality standards.

Most Asian countries will have their own specific form of Good Manufacturing Practice (GMP) standards. Some will be closer to international standards than others. Taiwan, Singapore, and Hong Kong quality assurance/quality control systems will usually be much more developed than in the other Southeast Asian countries. For example, in Taiwan, applicants registering their medical device must also submit Quality System Documentation (QSD) to receive product registration approval. Singapore requires companies involved in the wholesale or import of medical devices to obtain Good Distribution Practice for Medical Devices (GDPMDS) certification, which regulates how the devices are stored, transported, and handled.

For any Asian country, auditing and performing due-diligence on-site is the most important step in qualifying the facility that you are interested in. This step should never be skipped before setting up any type of contract. Pacific Bridge Medical can help audit factories in Asia to comply not only with local GMP standards but also US, EU and international ISO standards.

For a free consultation with our quality management experts, contact us now.

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