REGULATED BY THE MEDICAL DEVICE AUTHORITY (MALAYSIA) LICENSE NO. MDA-5880-W124

TOOP Capital
TOOP Capital
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    • Home
    • About Us
    • Accreditation
    • Partnership
    • Registered Products
    • Flagship New Products
    • Registration Services
    • Articles
    • Contact Us
  • Home
  • About Us
  • Accreditation
  • Partnership
  • Registered Products
  • Flagship New Products
  • Registration Services
  • Articles
  • Contact Us

"End-to-End" Product Registration & Licensing

STEP 1 Market Entry Assessment

STEP 2 Legally Appointed Representative

STEP 2 Legally Appointed Representative

We will meet to review product portfolio, regulatory landscape and market entry requirements

STEP 2 Legally Appointed Representative

STEP 2 Legally Appointed Representative

STEP 2 Legally Appointed Representative

We will be your Authorised, Licensed and Regulated Representative in Malaysia. Providing access to market and regulatory oversight

STEP 3 Expert Product Registration

STEP 2 Legally Appointed Representative

STEP 4 Post Market Approval Compliance

We will advise documentation requirements for registration including CSDT dossier preparation, supported by manufacturing evidence and certification. Submission will be completed and monitored  all the way until approval.

STEP 4 Post Market Approval Compliance

STEP 6 Update Purchasing Trends & Specific Ministry of Health Requirements

STEP 4 Post Market Approval Compliance

We will manage your regulatory correspondence, renewals and vigilance reporting

STEP 5 Provide Market Support & Distributor Alignment

STEP 6 Update Purchasing Trends & Specific Ministry of Health Requirements

STEP 6 Update Purchasing Trends & Specific Ministry of Health Requirements

We will assist in identifying MDA-Licensed distributors and product importers to aid with your transport logistics

STEP 6 Update Purchasing Trends & Specific Ministry of Health Requirements

STEP 6 Update Purchasing Trends & Specific Ministry of Health Requirements

STEP 6 Update Purchasing Trends & Specific Ministry of Health Requirements

We will provide insight into specific government and private sector product requirements to aid in your R&D resource allocation and to ensure you are best placed for product supply optimisation.

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