After applying for B-class medical device registration in Indonesia with the Ministry of Health (MOH) and BPOM, it is important to comply with ongoing regulations and requirements to ensure that the device remains in good standing throughout its market lifecycle. Below are the key regulations and requirements that must be adhered to after submission and during the approval process, and throughout the post-registration phase:

1. Compliance with BPOM Regulations

• Regulatory Framework: Medical devices in Indonesia are regulated under the Medical Device Act (UUD No. 36/2009) and BPOM regulations (specifically BPOM Regulation No. 31 of 2018), which govern the registration, importation, distribution, and surveillance of medical devices.
  • BPOM’s role: BPOM is responsible for reviewing, approving, and monitoring the safety, quality, and efficacy of medical devices on the market. Manufacturers and importers must comply with BPOM’s guidelines and requirements during and after the registration process.

2. Device Registration Approval Process

• Initial Submission Review: BPOM will review the submitted documents for completeness, accuracy, and compliance with Indonesian medical device standards. This includes:

  • Verification of device classification (B-class).
  • Assessment of clinical evaluation, safety, and performance testing.
  • Evaluation of the labeling and Instructions for Use (IFU).
  • Verification of manufacturing processes and certification.

  The approval process typically takes around 2-4 months, but can vary based on the complexity of the device and the completeness of the submission.

• Approval Notification: If the device meets BPOM’s requirements, **BPOM will issue the **Surat Izin Edar (SIE)****, which is the official approval to market the medical device in Indonesia.

3. Post-Market Surveillance (PMS)

• Continuous Monitoring: Once the device is approved and placed on the market, the manufacturer (or authorized representative) is required to maintain an active post-market surveillance (PMS) system. This involves ongoing monitoring of the device's safety, performance, and quality in the real world.
  • Collect feedback from healthcare professionals and users.
  • Track product complaints, adverse events, and failures.
  • Report any adverse events or product defects to BPOM within the required time frame (usually 10 working days).
• Post-Market Clinical Follow-up: For some B-class devices, especially those involving critical or high-risk functions, post-market clinical studies or follow-up evaluations may be required to assess the device's long-term safety and efficacy.

4. Adverse Event Reporting

• Mandatory Reporting: BPOM requires manufacturers to report any adverse events (e.g., device malfunctions, safety issues, injuries, or deaths) associated with the device. These events must be reported to BPOM:
  • Serious adverse events must be reported within 10 working days.
  • Non-serious adverse events should also be reported, but with a longer time frame.
• Corrective Actions: If an adverse event indicates a potential issue with the device's safety or performance, manufacturers are required to take corrective actions, which may include product recalls, modifications to the device, or warnings to users.

5. Device Recall and Market Withdrawal

• Product Recall: If a device is found to be defective or unsafe, BPOM may require the manufacturer to initiate a product recall or market withdrawal. This can happen if:

  • The device poses a significant risk to patient safety.
  • There is non-compliance with BPOM standards.
  • The device does not meet the approved specifications or labeling.

• Recall Process: The manufacturer must work closely with BPOM to manage the recall process, which includes:

  • Notifying distributors, healthcare providers, and end-users.
  • Removing defective devices from the market.
  • Providing instructions for the return of recalled products.
  • Correcting any issues identified during the recall.

6. Annual Renewal of Registration

• SIE Renewal: The Surat Izin Edar (SIE) registration is valid for 5 years from the date of issuance. To continue marketing the device in Indonesia after this period, the manufacturer must submit an application for registration renewal. This process includes:
  • Submitting updated documents (e.g., new post-market surveillance data, any changes to the device or labeling).
  • Payment of the renewal fee.
• Compliance Check: BPOM may request additional information, such as updated clinical data, post-market surveillance reports, or other compliance documentation, when renewing the device registration.

7. Changes to the Device

• Notifying BPOM of Changes: If there are any significant changes to the device (e.g., modifications to design, materials, intended use, or manufacturing process), BPOM must be notified. This could trigger the need for a re-evaluation or re-registration of the device.
  • Substantial changes may require submitting new clinical evaluation or testing data.
  • Minor changes (such as updates to packaging or labeling) may not require full re-registration, but BPOM must be informed.
• Device Modification Approval: Any change that affects the safety, efficacy, or performance of the device requires BPOM's approval before the modified device can be marketed.

8. Labeling and Instructions for Use (IFU)

• Compliance with Indonesian Language Requirements: The device labels and Instructions for Use (IFU) must be in Bahasa Indonesia. Ensure that they are updated to reflect any changes in the device’s safety information, intended use, or regulatory requirements.

• Product Labeling: Labels must include:

  • Device name, model, manufacturer details.
  • Usage instructions, warnings, and precautions.
  • Storage conditions (e.g., temperature and humidity).
  • Expiry dates (if applicable).

9. Distribution and Importation Compliance

• Importation: If the device is imported, the importer must ensure compliance with BPOM’s importation requirements, including proper customs clearance and storage regulations.

• Distributor Authorization: Only authorized distributors who are registered with BPOM may distribute the device in Indonesia. The manufacturer (or authorized representative) must maintain proper oversight to ensure that distributors comply with BPOM regulations.

10. Inspections and Audits

• BPOM Inspections: BPOM may conduct inspections of the manufacturing facility (if located abroad) or the local distributor to verify compliance with regulatory requirements, including:

  • Good Manufacturing Practices (GMP).
  • Quality control and product testing procedures.
  • Post-market surveillance activities.

• Internal Audits: Manufacturers should regularly perform internal audits to ensure ongoing compliance with BPOM regulations and identify any potential issues before BPOM inspections.

11. Ongoing Regulatory Updates

• Stay Updated on Regulations: The regulatory environment for medical devices in Indonesia is subject to change. Manufacturers must regularly check for updates to BPOM’s medical device regulations, standards, and guidelines.
  • BPOM may issue new regulations, amend existing rules, or introduce new compliance requirements (e.g., changes in risk classification criteria, safety testing standards).

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