Pre-Market Approvals -
Pre-Market Approvals -
Malaysia MDA and Singapore HSA
Malaysia MDA and Singapore HSA
Whether you operate a subsidiary in Malaysia/Singapore or prefer to appoint me as your authorized representative, I take care of the entire product registration process for you.
Medical Device Authority (Malaysia):
Product Classification
Conformity Assessment Application and Certification
a) Conformity Assessment by way of Verification
b) Full Assessment
Medical Device Registration
Health Sciences Authority (Singapore):
Product Classification
Medical Device Registration
a) Immediate Route
b) Expedited Route
c) Abridged Route
d) Full Route
For details about my authorized representative service, please visit our Authorized Representative service page.