Once your oximeter is registered with HAS (Health Sciences Authority) in Singapore, you will need to comply with a series of dos and regulations to ensure that your device is operating under compliant and safe conditions. Here are some things to look out for:
Operate legally: Make sure your oximeter is operating legally in Singapore. Only devices registered through HAS can be legally sold and used in the market.
Compliance Requirements: Strict compliance with HAS and other relevant rules and regulations, including safety, performance, and quality standards for equipment. Make sure your equipment meets all regulatory requirements.
Certificate of Registration: Regularly check and make sure your HAS Certificate of Registration is up to date. Certificates of enrollment usually have an expiration date, and you will need to renew them on time and pay for them to avoid the license expiring.
Equipment Maintenance: Regular maintenance and upkeep of the equipment is carried out to ensure its performance and safety. Depending on the requirements of HAS, it may be necessary to develop and execute a maintenance plan.
Equipment Safety: Ensuring the safety of the equipment includes regular inspections of the structural, electrical and mechanical components of the equipment, as well as following relevant safety operating procedures.
Records and Reports: Maintain detailed records, including equipment maintenance records, inspection reports, and incident reports. Depending on the requirements of HAS, you may be required to report any equipment accidents or malfunctions.
Training and Qualifications: Ensure that equipment operators have the necessary training and skills to safely operate and maintain oximeters. Make sure they have the relevant qualifications and certifications as needed.
Compliance Audits: Regularly audited and inspected by HAS or relevant authorities to ensure that your equipment and operations remain compliant with regulatory requirements.
Communications and contact information: Ensure that HAS and other regulators can contact you at any time for important information or for review. Keep your contact information up to date.
Contingency Planning: Have a contingency plan in place in case of a possible equipment accident or emergency. Ensure that equipment operators understand and are able to execute these plans.