Licenses

Quality Affairs and Regulatory Affairs are a major component of a medical device company and our team has spent a considerable amount of time and effort to ensure that we comply with all requirements.

Regulatory Approvals

ISO13485
Certificate

FathomX is an ISO13485 certified company. ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

HSA Manufacturing
License

The Health Sciences Authority is a statutory board under the Ministry of Health of the Government of Singapore and is the regulatory authority for medical devices. FathomX has obtained a manufacturing license and is awaiting regulatory approval.

HSA Class B
Certificate

FathomX's products are classified as a Class B Device by the Health Sciences Authority of Singapore and have obtained approval.

Thai FDA Class II
Certificate

FathomX's products are classified as a Class II Device by the Thailand Food and Drugs Administration have obtained approval.

Taiwan Quality Management System

FathomX is certified to have complied with the quality management system of Taiwan Food and Drug Administration

Malaysia CAC QMS Certificate

FathomX is certified to have complied with the quality management system of Malaysia's Medical Device Act 2012 (Act 737) and Medical Device Regulations 2012

Malaysia MDA Class B Certificate

FxMammo is certified as a Class B Device under Malaysia's Medical Device Authority

Licenses

Regulatory Approvals

ISO13485 Certificate

HSA Manufacturing License

HSA Class B Certificate