DH's Medical Device Administrative Control System receives ISO 9001:2015 certification
The Medical Device Administrative Control System (MDACS) of the Department of Health (DH) has been awarded the ISO 9001:2015 Quality Management Systems (QMS) Certificate, developed by the International Organization for Standardization (ISO). The award ceremony was held today (January 5). The achievement of the MDACS in obtaining this international standard marks an important milestone in laying the foundation for the establishment of the Hong Kong Centre for Medical Products Regulation (CMPR) by the DH at the end of this year. This accomplishment will facilitate international recognition and foster an innovation-friendly environment.
The ceremony took place at the DH's headquarters. The Director of Health, Dr Ronald Lam, said, "The Hong Kong Special Administrative Region Government is committed to raising regulatory standards for medical products in Hong Kong. With the establishment of the CMPR, we will consolidate regulatory functions for Western and Chinese medicines, as well as medical devices, thereby enhancing the existing regulatory regime in a holistic manner. The DH is proceeding at full speed with preparatory work, guided by three key strategies: promoting regulatory excellence, fostering innovation in pharmaceuticals and medical devices, and deepening co-operation with the Chinese Mainland and overseas countries. The ISO accreditation, which covers all aspects of the MDACS (including pre- and post-market control), will strengthen confidence among industry professionals both in Hong Kong and internationally, as well as among the general public. It will encourage more medical device manufacturers and importers to voluntarily list their medical devices with the MDACS. In the long run, it will also help facilitate a smooth transition for listed products to the statutory regulatory framework."
To safeguard public health, the DH has drawn on recommendations from the Global Harmonization Task Force (now known as the International Medical Device Regulators Forum) and introduced the voluntary MDACS in 2004. The system involves approving the list of medical devices to ensure their safety, quality, and performance, establishing a trader listing system, and implementing a post-market monitoring system for products.
"Currently, over 8 900 medical devices are listed under the MDACS. In response to the latest international trends in medical device regulation and to align with the establishment timeline of the CMPR, the Government is pressing ahead with legislative preparations and comprehensively reviewing the proposed regulatory framework. Legislative proposals are expected to be submitted to the Legislative Council this year. Under the new framework, all medical devices supplied in Hong Kong will require registration unless exempted, ensuring compliance with relevant safety, quality, and performance standards," Dr Lam said.
ISO 9001 is an internationally recognised QMS standard developed by the ISO. It assists organisations in establishing consistent procedures to ensure their products and services consistently meet customer and regulatory requirements, ultimately enhancing customer satisfaction and promoting sustainable business development. This standard is one of the most widely adopted quality improvement frameworks worldwide, improving operational efficiency and quality through risk-based thinking and continuous improvement.
The Medical Device Division of the DH initiated the establishment of its QMS in 2025 and obtained ISO 9001:2015 QMS certification in December of the same year. Additionally, the DH's Drug Office obtained ISO 9001 QMS certifications in 2005 for drug traders licensing procedures and inspection of undesirable medical advertisements, and in 2009 for its manufacturer licensing and quality management standard inspections. The relevant QMS will continue to be implemented after the establishment of the CMPR.
DH's Medical Device Administrative Control System receives ISO 9001:2015 certification Source: HKSAR Government Press Releases
DH's Medical Device Administrative Control System receives ISO 9001:2015 certification Source: HKSAR Government Press Releases
