Japan
The Health Sciences Authority (HSA) is the authority responsible for medical device vigilance and quality control. All medical devices are classified based on risk-based classification rules that can be compared with the classification systems of FDA, European Union, MDB, MHLW and TGA. The classification system knows a Class A, B, C and D, where Class A is low risk and D high risk. All devices must be registered with HSA prior to placing them on the Singapore market unless exempted as some of the low risk non-sterile Class A devices. Submission takes place through the Medical Device Information and Communication System (MEDICS) and registrations do not expire but require an annual retention fee.
All documentation to support the registration of medical devices must be compiled in the ASEAN Common Submission Dossier Template (CSDT) format.There are abridged, expedited and immediate evaluation routes possible.
Local license holder
Companies without an establishment in Singapore are required to appoint a local authorized representative. Any company importing medical devices into Singapore is required to hold an importer's license. Importers of medical devices of risk categories other than Class A are required to be certified to GDPMDS as a pre-requisite for licence application.
Language
All documents to be submitted in support of product registration must be provided in English and all information on the labels of medical devices supplied in Singapore must be provided in English, though non-English information may be included as long as it is in consistent with the English information.