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Exhilarating news! Majesty Achieves ISO 13485 Medical Devices Quality Management Systems Certification




Jan 10th, 2023, after rigorous review by experts, Majesty Packaging Systems Co., Ltd. has successfully passed the ISO 13485:2016 Medical Devices Quality Management Systems Certification. This certification covers the design and manufacture of medical irrigation head, meets the requirements of the international standards organization for quality management system


This is an affirmation of Majesty's management system and product quality and also a opportunity for Majesty to develop overseas medical device market and establish cooperation with international pharmaceutical enterprises. Majesty has a headquarter in Zhongshan City, a branch in Hong Kong, plants in Thailand and Brazil, and lots of sales locations around the world. Our partners with customers in over 40 countries.
Furthermore, Majesty has obtained Chinese Registration Certificate for Packaging Material and Container for Pharmaceutical use (sectionⅠ), ISO9001, ISO14001 and ISO45001 system certification. Majesty is the largest pharmaceutical aerosol valve and pharmaceutical aerosol pump manufacturer in China.



The full name of ISO13485is Medical device-Quality management systems-Requirements for regulatory purposes, it is an independent international standard developed by the International Organization for Standardization (ISO) and applicable to the medical device industry. The current version of ISO13485 is version 2016, which was officially released on March 1, 2016. This standard emphasizes the importance of implement medical device regulations, and ensures the safety and effectiveness of medical device by meeting the requirements of medical device regulations. ISO13485 certification reflects the construction of medical device enterprises' quality management system must take safety and effectiveness as principle, subject to legal constraints, and be legal compliance. It is also need to fully considerate the risks of medical device product, and risk management is required throughout the process.

This is an affirmation of Majesty's product quality, it will encourage us to continuously improve the quality management level and ensure the product quality. Majesty will take this certification as a springboard to improve the internal quality control, service level to provide superior quality products and services by in strict accordance with the quality management system standards and continue to fine management as the basis for security. We will contribute to the domestic and foreign medical device market and pharmaceutical industry.

We welcome the major pharmaceutical enterprises and comprehensive health industry to further negotiate with our company to cooperate in research and development, and to promote the development of China's pharmaceutical industry.


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