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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 pre-market 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. Registration is typically issued within 15–30 working days. CDSCO may verify compliance and audit the declaration through post-market inspection at any time.

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.