Medical Device Registration

Description

We offer complete Medical Device Registration services with the Medical Device Authority (MDA) Malaysia. All medical devices—ranging from Class A (low risk) to Class D (high risk)—must be registered before being sold in the market. Our service includes device classification, conformity assessment support, Common Submission Dossier Template (CSDT) preparation, label compliance, and online submission via the MedCAST system. We also coordinate with registered conformity assessment bodies (CABs) where required. Whether you’re a manufacturer, importer, or distributor, we help ensure your product complies with Malaysian medical device regulations, enabling smooth market entry and avoiding enforcement issues or delays.)

📌 What’s Included

• Device Classification (Class A, B, C, D)

• Conformity Assessment Support

• CSDT (Common Submission Dossier Template) Preparation

• Label Compliance Review

• Online Submission via MedCAST

• Coordination with Registered CABs (Conformity Assessment Bodies)