Due to the escalating situation of the COVID – 19 pandemic in Singapore, the demand for respiratory devices such as ventilators is growing rapidly. The HSA is committed to ensure the accessibility to these essential medical devices during this time to meet local healthcare needs. As such, the HSA has placed regulatory flexibility for the management of the anticipated increase in demand for respiratory devices for COVID – 19 patients. This flexibility will remain in effect during the period of pandemic and will be revised according to the local situation. The following situations are included in the said regulatory flexibility:
- Anesthesia machines and positive airway pressure devices will be allowed as emergency ventilators for COVID – 19 patients provided they are safe to use. HSA is very much aware of the shortage of ventilator supply globally. As such, the potential use of anesthesia machines and positive airway pressure devices will be permitted if the manufacturer have developed specific instructions to support the safe use of HSA – registered anesthesia machines or positive airway pressure devices as ventilators for treating COVID-19 patients. On – going support must also be provided. Healthcare institutions must work closely with manufacturers and/or local dealers to ensure their safety to use as ventilators because anesthesia machines are designed very differently from ventilators. Approval for these devices will not be required.
Implementation of changes to HSA – registered ventilators will also be affected as global demand is increasing. To meet this demand, changes such as establishment of new production lines and/or manufacturing sites to increase manufacturing capacity, allowing use of more models of accessories, and upgrading existing products via software or hardware modifications are being made. Following the regulatory process, applicants must submit a change notification application. The changes are listed in the GN – 21: Guidance on Change Notification for Registered Medical Devices. In order to expedite the application, an alternative pathway was created where standard change notification process will no longer be applied. HSA’s approval will not be needed if:
- - The changes will not affect registered performance specifications, and
- - The devices, as well as the accessories, continue to meet the Essential Principles of Safety and Performance as set out in the Health Products (Medical Devices) Regulations 2010.
Notifications must be made with minimum information on a 6 – monthly basis. Approval for these changes is not required. If criteria for the changes are satisfied, they will be collated in a “Summary of Change” template and will notify HSA using a link that is available on the original article in the HSA website.
3. Unregistered/new model ventilators that will be supplied to meet local clinical needs should be consulted by the manufacturer to the HSA by sending an email with the subject “Supply of unregistered ventilators in Singapore”. HSA will then contact them and provide them with relevant advice.
References:
Reference: HSA's Regulatory Position on Respiratory Devices: Supply for Management of COVID-19 Patients