The Macau Legislative Assembly (AL) yesterday passed the outline of a local government-drafted bill to establish a comprehensive framework to manage and monitor the research, development, registration, filing, manufacture, and operation of medical devices.
Introducing the bill during a plenary session in the legislature’s hemicycle yesterday, Secretary for Social Affairs and Culture Elsie Ao Ieong U said that medical devices are an integral part of the modern medical and healthcare system, and their quality, safety and efficacy are directly related to the health of patients and users.
The bill is divided into two main sections, namely the medical device registration and filing, and the medical device business activities, which proposes the issuance of manufacturing licences or operating licences, and also categorises medical devices into three risk levels: Class I (low risk), Class II (medium risk), and Class III (high risk).
Most of the products in the market, including bandages, gauze and thermometers, are classified as Class I or Class IIA, according to the bill. Travellers bringing in blood pressure monitors or residents buying thermometers outside Macau can bring them into Macau for personal use as long as they cost below 5,000 patacas.
Some lawmakers raised concerns about the implementation of the new system.
Attending yesterday’s plenary session, the Pharmaceutical Supervision and Administration Bureau (ISAF) Director Choi Peng Cheong clarified that establishments would not require an operating licence to sell low-risk items such as plasters, elastic adhesive bandages and thermometers, which fall under Class I and Class IIA medical devices. These items must, however, be registered through the government’s electronic platform to facilitate monitoring and sampling inspections, allowing them to remain available in pharmacies and supermarkets.
Choi also addressed the use of laser devices in beauty salons, noting that while low-frequency lasers can be utilised for non-medical hair removal services, high-frequency lasers for medical procedures like mole or wart removal would be prohibited, adding that the government plans to develop detailed guidelines for beauty salons to ensure compliance.
Pharmaceutical Supervision and Administration Bureau (ISAF) Director Choi Peng Cheong attends yesterday’s plenary session in the Legislative Assembly’s (AL) hemicycle. – Photo courtesy of TDM
