HSA's Regulatory Position on Respiratory Devices: Supply for Management of COVID-19 Patients
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UPDATE:
The following regulatory measures will be discontinued with immediate effect. All standard regulatory controls for medical devices will apply.
For an overall understanding of processes and requirements for product registration and licensing of dealers, you may refer to our Quick Guide available at http://www.hsa.gov.sg/medical-devices/regulatory-overview
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Ventilatory support devices play a critical role in the clinical management of COVID-19 (Coronavirus Disease 2019) patients, especially those with serious respiratory illnesses.
The Health Sciences Authority (HSA) is committed to ensure timely access to these essential medical devices to help meet local healthcare needs. Given the evolving situation in Singapore, HSA has decided to put in place regulatory flexibility to manage the anticipated increased demand of respiratory devices for COVID-19 patients.
This regulatory flexibility will remain in effect during the COVID-19 pandemic period and will be revised based on the local situation.
1. Allowing safe use of anaesthesia machines and positive airway pressure devices as emergency ventilators for COVID-19 patients
Where possible, healthcare institutions should use HSA-registered ventilators to support patients with respiratory failure.
HSA is cognizant that with the global supply shortage of ventilators, healthcare institutions may consider the potential use of existing anaesthesia machines or positive airway pressure devices in their facilities capable of providing controlled ventilation or assisted ventilation as emergency ventilators for COVID-19 patients.
Weighing the relative benefits of this approach, HSA will not object to such usage during this period, provided the device manufacturers have developed specific instructions to support the safe use of their HSA-registered anaesthesia machines or positive airway pressure devices as ventilators for treating COVID-19 patients. No approval from HSA is required.
Manufacturers or local dealers should provide clear and specific instructions on the use of anaesthesia machines or positive airway pressure devices for ventilation purposes to the healthcare institutions and relevant specialists to ensure successful implementation. They must also provide ongoing support for use for this purpose.
As there are design differences between anaesthesia machines or positive airway pressure devices as compared to ventilators, healthcare institutions are advised to work closely with the manufacturers or local dealers of the anaesthesia machines and positive airway pressure devices to ensure their safe use as ventilators.
2. Facilitating implementation of changes to HSA-registered ventilators
HSA is aware that manufacturers are working to manage the increased global demand for ventilators and related accessories. This can be achieved by adding new production lines or manufacturing sites to increase manufacturing capacity, allowing the use of more models of accessories with the ventilators, and upgrading the existing ventilators through software upgrades or hardware modifications to facilitate use on COVID-19 patients.
Based on the current regulatory process, registrants are required to submit a change notification application to HSA for some changes to registered ventilators. These changes are listed in GN-21 Guidance on change notification for registered medical devices. Also, some of these changes can only be implemented and/or supplied upon HSA’s approval.
Eligible changes
As part of our efforts to ensure continued availability of these devices to meet local healthcare needs, HSA has created an alternative pathway for upgrades or modifications to registered ventilators and their accompanying accessories (e.g. breathing circuits, filters and tubings) that do not create undue risk to the patients using them. This alternative pathway is also applicable for registration of new models of accessories for use with the registered ventilators. Where the alternative pathway is used, the standard change notification process will no longer apply.
Registrants may implement these changes to the registered ventilators without waiting for HSA’s approval as long as
a) The changes do not affect the registered performance specifications, AND
b) The devices, including the new accessories, continue to meet the Essential Principles of Safety and Performance as set out in the Health Products (Medical Devices) Regulations 2010
Registrants are only required to notify HSA with minimum information on these changes on a 6-monthly basis. HSA’s approval for these changes is not required.
We would like to remind all Registrants that it is their responsibility to ensure the changes have been validated and the registered device remains safe and effective. Supporting validations must be made available to HSA when requested. All manufacturing facilities or activities, including those of the new models of accessories, shall meet the ISO 13485 requirements.
Notification to HSA
For changes that fulfil the above criteria, registrants shall collate the changes using the “Summary of Change” template below and notify HSA on a 6-monthly basis using the following URL:
URL: https://form.gov.sg/5e7d9ffe4cf17f001148e69b
Summary of Change Template11 KB
Please note that local dealers of the above devices are subject to post-market duties and obligations as stipulated in the Health Products Act and the Health Products (Medical Devices) Regulation 2010, including reporting of adverse events arising from the use of these medical devices, reporting of Field Safety Corrective Actions and recalls related to these devices.
3. Supplying unregistered or new models of ventilators to meet local clinical needs
Companies that wish to supply ventilators that are currently not registered with HSA to meet local clinical needs may email us here with the subject ‘Supply of unregistered ventilators in Singapore’. We will contact you and provide you with the relevant advice.
The Table below includes a list of ventilators that have received provisional authorisation to date. This list will be updated with new authorised ventilators.
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