ABSTRACT
To ensure good quality, many international standard bodies (e.g., ISO and BSI) and local standard bodies in many countries such as the United States, Japan, and China actively develop better product standards for manufacturers so that products with better specifications are manufactured. After a product with good specifications has been developed, its production needs to be done within a good system, too (e.g., GMP and ISO 13485), and the process needs to be regularly audited by certification bodies and governments. As regulatory professionals, we need to understand this and explain this to relevant government bodies and finally obtain relevant approvals before supplying the product to patients.
