Quality Systems for Medical Devices

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

More and more medical device companies are sourcing/manufacturing their medical device products and components in various Asian countries.

Most Asian countries will have their own specific form of Good Manufacturing Practice (GMP) standards. Some will be closer to ISO 13485 than others. The quality systems in countries such as Hong Kong, Korea, Singapore, and Taiwan will usually be much more developed than in the other poorer countries. For example, in Taiwan, applicants registering their medical device must also submit Quality System Documentation (QSD) to receive product registration approval.

For any Asian country, auditing and performing due-diligence on-site is the most important step in qualifying the facilty 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 more information on Asian medical device quality issues, please see the following PBM publications and/or contact us to discuss your specific needs.

Sourcing Medical Devices in Asia 2010 (publication for sale)
Looking East for R&D and Clinical Trials
A Regulatory Update on Asia's Smaller Medical Device Markets
Vietnam's Medical Markets (webcast for sale)
Taiwan Medical Device Regulations Presentation (presentation for sale)
Drug, Device and Cosmetic Regulations in Malaysia: 2005 Update