Medical Device Registration: Requirements, Process, and Costs

General Requirements

The requirements for medical device registration must be submitted using the following five forms:

• Form A: Administration
• Form B: Product Information
• Form C: Product Specifications and Quality Assurance
• Form D: Usage and Instructions for Use
• Form E: Post Market Surveillance System

Distribution Permit Application Process

Applicants submit medical device registration applications electronically through the website www.regalkes.depkes.go.id. The registration process consists of two main stages: pre-registration and registration.

1. Pre-registration

At this stage, applicants first determine the medical device class and then proceed to pay the PNBP fees by following these steps:

1. Form Submission: The applicant fills out and submits the application form online.
2. Class Determination: The assessor will determine the class of the registered medical device within 7 days.
3. PNBP Payment: First, the applicant receives a PNBP Payment Order (SPB) based on the medical device class. After receiving the pre-registration notification, the applicant must promptly make the payment and then upload proof of payment within 10 days.
4. Payment Verification: The PNBP Admin will verify proof of payment and send a fixed receipt to the applicant.

2. Registration

This stage involves the evaluation and verification of the safety, quality, and benefits of medical devices:

1. File Evaluation: The Assessment Team evaluates and verifies application files online.
2. Evaluation Results: Results are provided via the company account on the registration site or email, and may include approval, deficiency notifications, or rejection.
3. File Processing: Complete files are processed for permit approval.
4. Correction of Deficiencies: Applicants have 30 days to correct deficiencies and can submit corrections twice, each within 30 days of notification.
5. Re-evaluation: Corrections are re-evaluated within 30 days for class A and 45 days for classes B, C, and D.
6. Rejection: However, if the applicant fails to correct the deficiencies, a Rejection Letter will be issued. Consequently, the applicant must reapply. PNBP fees are non-refundable for rejected applications.

Service Time and Cost

The time and cost for a medical device distribution permit depend on the device class and start from the issuance of a receipt after payment verification.

Note: The PNBP fee for the application for a distribution permit for medical devices is in accordance with applicable provisions.

Related Links:

• Production Permit for Cosmetics Class A and B
• Medical Device Registration
• PIF
• Cosmetic Product Registration
• Renewal of Medical Device Distributor License (IPAK) Announced