The Singapore Health Sciences Authority (HSA) released an announcement that QMS requirements for Class A medical devices have been reduced. Essentially, all that is required now is a signed Declaration of Conformity.
Foreign device companies have complained about the difficulty of fulfilling Class A medical device QMS requirements in Singapore for several years. In response to the feedback, the HSA recently streamlined the process for Class A medical device QMS requirements. Thus, a QMS standard ISO 13485 certification is no longer mandatory due to the low risk of Class A devices.
For Class A medical device applications that do not have ISO 13485 certification, US FDA Quality System Regulations, or Japan MHLW Ordinance 169, the product owner is required to sign an attestation that a self-declared quality management system has been established.
If a Class A medical device application has already been submitted, and a QMS standard to ISO 13485 certification was not included, registrants must submit the updated Declaration of Conformity. A Declaration of Conformity Template can be found in the guidance document: GN-11, Guidance on the Declaration of Conformity. The guidance document can be found on the HSA website at http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/medical_devices/regulatory_guidances.html.