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Checklist of Requirements for Promo Permit Application

FDA medical device registration checklist for the requirements of promo permit application

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Revision No. 01 Date Effective: 18 October 2017

CHECKLIST OF REQUIREMENTS FOR SALES PROMO PERMIT
APPLICATION/AMENDMENT
INITIAL
1.
2.
3.
4.
5.

Letter of Intent for application of Promo Permit
Information sheet
Copy of the valid product notification/registration/exemption
Layout of Promo materials (if applicable)
Proof of payment

AMENDMENT
1.
2.
3.
4.

Letter of Intent specifying the type of amendment
Copy of previously issued valid promo permit
Supporting documents for the requested amendment
Proof of payment

Note:
• Applicant company to coordinate with the Central Releasing Unit for the procedure of releasing of promo permit via
Courier Service (As per FDA Circular 2014-012 Requiring Proof of Courier Service Payment for Promotion and
Advertisement Permit)
 
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