B-class medical device registration in Indonesia refers to the regulatory process for registering moderate-risk medical devices with the Ministry of Health (MOH) and the National Agency of Drug and Food Control (BPOM) in Indonesia. These devices are subject to a specific regulatory framework that ensures they meet safety, efficacy, and quality standards before being marketed or distributed in Indonesia.

Key Characteristics of B-Class Medical Devices:

1. Moderate Risk:

   • B-class medical devices are categorized as moderate-risk devices. This means they are not considered as high-risk as Class A (low risk) devices but still require regulatory oversight to ensure patient safety.
   • They typically include devices that do not require clinical trials or significant invasive procedures, but still need to meet safety and performance standards.

2. Device Categories:

   • B-class devices can include products such as:
     • Diagnostic equipment and kits
     • Non-invasive monitoring devices
     • Dental instruments
     • Certain surgical instruments
     • Laboratory equipment
     • Medical imaging devices

3. Regulatory Framework:

   • Medical devices in Indonesia are classified into four categories: A (low risk), B (moderate risk), C (high risk), and D (highest risk). B-class devices fall into the moderate-risk category.
   • These devices need to undergo technical review and meet the regulatory requirements set by BPOM to ensure their safety and efficacy.

4. Registration Requirements:

   • Registration is mandatory for all medical devices to be legally sold or distributed in Indonesia.
   • The registration process for B-class devices involves the submission of documentation including device descriptions, clinical data (if applicable), risk management plans, product labeling, and certificates such as ISO 13485 and Certificate of Free Sale (CFS).
   • A local representative (if the manufacturer is based abroad) must be appointed to manage the registration process in Indonesia.

5. Surat Izin Edar (SIE):

   • After successful review and approval by BPOM, the medical device will receive the Surat Izin Edar (SIE), which is the official registration certificate.
   • The SIE allows the device to be marketed and sold in Indonesia and is valid for 5 years.

6. Post-Market Requirements:

   • After registration, the device must comply with ongoing post-market surveillance and adverse event reporting requirements.
   • Manufacturers or local representatives must monitor the device’s performance in the market and report any safety issues or failures to BPOM.

B-Class Device Registration in Indonesia:

The registration process for B-class medical devices involves the following key steps:

1. Preparation of Documents:

   • Manufacturers must provide detailed technical documentation to BPOM, which includes device specifications, safety data, testing reports, clinical data (if applicable), and certificates such as CFS and ISO 13485.

2. Submission via e-Registration Portal:

   • All applications must be submitted online via BPOM's e-Registration portal. The local authorized representative in Indonesia (for foreign manufacturers) is responsible for submitting the application and managing the process.

3. Review and Evaluation:

   • BPOM reviews the submitted documents for completeness and ensures the device meets regulatory requirements. This includes technical evaluation, safety assessments, and review of clinical data (if applicable).

4. Issuance of Surat Izin Edar (SIE):

   • Once approved, BPOM issues the Surat Izin Edar (SIE), which grants the right to market and distribute the device in Indonesia.

5. Ongoing Compliance:

   • Manufacturers must ensure ongoing compliance with post-market surveillance and renewal of the SIE every 5 years.

In Summary:

B-class medical device registration in Indonesia means that a moderate-risk medical device must go through a regulatory approval process to ensure it meets safety, quality, and efficacy standards before being allowed on the Indonesian market. This process is crucial for ensuring that the devices used by patients and healthcare professionals in Indonesia are safe and effective.

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