SMDI - Medical Device Clinical Studies Support Scheme

What it is

Reduce the cost barrier to clinical evidence generation for investigational and approved medical devices and support safer, more export-ready products.

What you get

• Medical-device clinical studies and post-market evidence support

Who it is for

• the device and study are eligible under current clinical-studies guidelines
• the applicant has the regulatory, ethics, site, protocol, investigator and safety arrangements required for the study
• the study is an eligible animal study, clinical investigation or post-market follow-up
• the proposal uses the current Department/PMA route and follows the 23 February 2026 modification

How to apply

1. 1
   Classify the study and device

   Determine whether the proposal is an animal study, clinical investigation or post-market follow-up and identify the device/regulatory class.

   Official step
2. 2
   Read the 2026 modification

   Apply the 23 February 2026 amendment before interpreting paragraphs 5.4 and 5.11 or preparing a claim.

   Official step
3. 3
   Prepare the protocol dossier

   Assemble regulatory, ethics, investigator, site, safety, budget, milestones and reporting evidence.

   Official step

Keep ready