What is Class A Medical Device Registration with Indonesia MOH?

Class A medical device registration is the process of obtaining official approval from Indonesia's Ministry of Health (MOH) for low-risk medical devices. These devices are classified as "Class A" based on their minimal risk to the patient or user (e.g., bandages, surgical gloves, or thermometers).

The registration is mandatory for all medical devices to be legally imported, distributed, and sold in Indonesia. The process ensures that the devices meet Indonesian safety, quality, and efficacy standards.

Steps to Apply for Class A Medical Device Registration

1. Understand Device Classification

• Confirm your device qualifies as Class A (low risk) under Indonesia's classification system.
• Refer to Indonesian regulations (Permenkes) or consult a regulatory expert for classification guidance.

2. Appoint a Local Authorized Representative

• Non-Indonesian manufacturers must appoint an Authorized Representative in Indonesia.
• The representative must be registered with MOH and will act as the license holder for the device.

3. Compile Required Documents

Prepare the following documents in line with MOH requirements:

1. Administrative Documents:

   • Local company license (SIUP or equivalent) of the authorized representative.
   • Manufacturer’s authorization letter for representation.

2. Technical Documents:

   • Device Description: Name, model, intended use, and physical characteristics.
   • Manufacturing Information: Manufacturing address and processes.
   • Safety and Performance Evidence: Test reports (e.g., electrical safety, biocompatibility).
   • Quality Management System (QMS):
     • ISO 13485 certificate (preferred).
   • Free Sale Certificate (FSC): Issued by the competent authority in the country of origin.
   • Labeling and Instructions for Use (IFU):
     • Translated into Bahasa Indonesia.
   • Risk Management File:
     • Include a risk analysis summary (per ISO 14971).

4. Submit Application via ASPAK (MOH Online System)

• Log in to the ASPAK system (Sistem Perizinan Alat Kesehatan) using the credentials of your authorized representative.
• Upload all required documents through the online portal.

5. Pay the Registration Fee

• Registration fees vary depending on the type and classification of the device.
• Payment instructions will be provided in the ASPAK system.

6. Undergo MOH Review

• MOH will review the submission for completeness and accuracy.
• For Class A devices, the review process is typically straightforward, given the low-risk nature of the products.

7. Obtain the Distribution License (Izin Edar)

• If approved, MOH will issue a registration certificate known as Izin Edar.
• This license is valid for five years and must be renewed before expiration.

8. Post-Market Obligations

• Comply with post-market surveillance requirements.
• Maintain device records and report any adverse events or recalls to MOH.
• Ensure the product continues to meet safety and performance standards.

Key Points to Note:

• Timeline: Registration for Class A devices typically takes 1–3 months if the documentation is complete.
• Local Requirements: Labels, user manuals, and other documents must be in Bahasa Indonesia.
• Local Representative: Your authorized representative plays a crucial role in managing the process and maintaining compliance.

If you need further clarification or specific assistance, let me know!

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