LCQ1: Regulation of medical consumables
It is learnt that there is no legislation regulating matters relating to the import and sale of medical consumables in Hong Kong. The sensitivity and specificity of medical consumables generally available for sale in the market, such as blood glucose test strips and pregnancy test sticks, are also not regulated. There are views that the market for medical consumables is like a "doorless coop" due to a lack of regulation and, with medical consumables varying in quality, members of the public may suffer the health consequences of delayed treatment caused by inaccurate test results. In this connection, will the Government inform this Council:
(1) of the number of complaints received by the Department of Health (DH) in the past four years about the poor quality of medical consumables (including rapid test kits), together with a breakdown by the type and place of origin of the medical consumables concerned;
(2) whether the DH requires medical consumables and rapid test kits to meet certain specifications; if so, of the details of the relevant specifications; if not, whether the authorities have considered laying down relevant specifications; and
(3) whether the DH has conducted tests to see if the medical consumables generally available for sale in the market meet the standards that allow members of the public to conduct tests on their own; if so, of the details; if not, the reasons for that?
Medical consumables mentioned in the question of the Hon Leung Man-kwong are classified as in-vitro diagnostic medical devices (IVDMDs) under the existing regime.
While there is not yet relevant legislation to regulate medical devices in Hong Kong, some may be regulated by existing pieces of legislation such as the Pharmacy and Poisons Ordinance (Cap. 138) depending on the characteristics of the products concerned. Making reference to the recommendation of the Global Harmonization Task Force (GHTF, now known as the International Medical Device Regulators Forum (IMDRF))(Note), the Department of Health (DH) has also introduced the voluntary Medical Device Administrative Control System (MDACS) since 2004, under which a listing system for medical devices and traders as well as a post-market monitoring system are in place. The objective is to ensure that medical devices supplied in Hong Kong can meet the requirements on safety, quality and performance.
Under the MDACS, the Government classifies medical devices into different classes according to their risk levels based on the medical device classification system adopted by the GHTF. General medical devices are classified into Classes I to IV, whereas IVDMDs are classified into Classes A to D. As for the medical consumables mentioned by the Hon Leung, they fall into the classification of Classes A to D. Local Responsible Persons of medical devices can apply for the listing of their medium to high risk medical devices, such as blood glucose test strips, pregnancy test sticks and rapid test kits. Medical devices of low risk, such as examination gloves, bandages, cotton wool, are not under the current scope of listing under the MDACS.
To apply for listing under the MDACS, a medical device must be proven to have met the requirements under the Essential Principles of Safety and Performance of Medical Devices adopted internationally. The applicant shall submit supporting documents, including certificate of the quality management system of the manufacturer such as ISO 13485, identification and technical description of the device, as well as marketing approval from specified reference jurisdictions or evaluation report of the medical device issued by a Conformity Assessment Body recognised by the DH.
When vetting a listing application of a medical device, the DH makes reference to the relevant international and regional technical standards, or the technical advice of other international organisations (e.g. the World Health Organization). To facilitate better understanding of the relevant listing requirements in the industry, the DH has prepared and uploaded to its website a list of recognised standards on medical devices for applicants' easy reference.
After the medical devices are listed under MDACS, there will be a post-market monitoring mechanism. The DH monitors safety alerts issued by overseas regulatory authorities, uploads the identified safety alerts to its website, and disseminates such information to healthcare institutions (including the Hospital Authority and private hospitals) and the relevant healthcare professional associations as appropriate. Furthermore, the MDACS has also set up the Medical Device Adverse Event Reporting System to handle reports of adverse events concerning listed medical devices and collect related information for analysis, with a view to enhancing protection for patients and users via early detection of safety signals.
Since 2019, we have 60 listed COVID-19 rapid antigen tests. The DH has received a total of three complaints about the quality of IVDMDs so far, all of which were related to COVID-19 rapid antigen tests. The manufacturers concerned were from Mainland China, Hong Kong and Germany.
Medical devices listed under the MDACS have to meet the requirements on safety, quality and performance. The Government encourages members of the public to make reference to the lists under MDACS in selecting medical devices. To this end, the DH has developed a thematic webpage to provide a one-stop platform for the public on more common medical devices. Taking the COVID-19 rapid antigen tests as an example, we have a thematic webpage listing the 60 COVID-19 rapid antigen tests aforementioned for citizen's reference. Responses have been encouraging, with the hit rate in viewing these listed rapid antigen tests reaching 1.2 million as at February this year. There are also information on safety alerts and the proper use of these devices available on the website. Although the listing under the MDACS is currently on a voluntary basis, the DH is now actively discussing with public healthcare institutions under the Health Bureau on the way to implement the prioritisation in the procurement of medical devices listed under the MDACS.
The DH will continue to promote and enhance awareness of the public, users and the industry on the MDACS, with a view to having more medical devices listed under the system. The Government will also review the statutory regulatory regime on medical devices and submit the legislative proposal in due course. Thank you, President.
Note: The GHTF was established in 1992 by regulatory authorities and trade representatives of the United States of America, Canada, Australia, Japan and the European Union to harmonise the standards and principles for the regulation of medical devices. It was disbanded in 2011, and a new IMDRF was formed to build on the work of the GHTF. The IMDRF aims to accelerate international medical device regulatory harmonisation and convergence, and its current members include China, Australia, Brazil, Canada, the European Union, Japan, Russia, Singapore, South Korea, the United Kingdom and the United States of America.
Ends/Wednesday, March 15, 2023
Issued at HKT 16:03
Issued at HKT 16:03