Guidance on Medical devices for an urgent public health need: Forms

On this page

• Part 1.1 new medical device application form
• Part 1.1 medical device authorization amendment form
• Part 1.1 private label application form
• Part 1.1 private label amendment application form

Part 1.1 new medical device application form

Part 1.1 new medical device application form (PDF version, 498 KB)

Part 1.1 medical device authorization amendment form

Part 1.1 medical device authorization amendment form (PDF version, 543 KB)

Part 1.1 private label application form

Part 1.1 private label medical device application (coming soon)

Part 1.1 private label amendment application form

Part 1.1 private label medical device amendment application (coming soon)