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Class A Import — Form MD-15 Self-Declaration

What is Form MD-15?​

Form MD-15 is a registration/self-declaration form for importing Class A (low-risk) medical devices into India. It does not require a full regulatory review by CDSCO; instead, the IAR makes a legally binding declaration that the device and manufacturer conform to all applicable Medical Devices Rules 2017 requirements. CDSCO may verify compliance through post-market inspection.

Process​

  1. Confirm the device is classified as Class A under MDR 2017;
  2. Confirm the device is notified in Schedule I or Schedule II;
  3. Submit Form MD-15 via the SUGAM portal, attaching:
    • Device description and specifications;
    • Evidence of GMP compliance;
    • Labelling specimens;
    • IAR appointment letter;
  4. Pay the applicable fee;
  5. Receive Form MD-15 registration acknowledgement.

Important notes​

  • Form MD-15 is for Class A devices only. Any device classified as Class B, C, or D requires Form MD-14.
  • If CDSCO determines that the device is incorrectly classified as Class A, the application will be redirected to the Form MD-14 pathway.
  • Class A registration under Form MD-15 does not exempt the device from labelling, vigilance, or post-market requirements.