The registration period for Class II medical devices with the Indonesian Ministry of Health (MOH) through BPOM typically lasts for 5 years from the date of approval.

Key Points:

• Validity of Registration: Once BPOM grants approval for the Class II medical device registration, the registration certificate is valid for 5 years.
• Renewal Process: Before the 5-year validity period expires, the manufacturer or authorized representative must apply for renewal. The renewal process usually requires submitting updated information about the device and ensuring continued compliance with Indonesian regulations.

Renewal Timeline:

• 6 Months Prior: It's advisable to start the renewal process at least 6 months before the registration certificate expires to avoid disruptions in market access.
• Review: During the renewal process, BPOM may request updated documents or inspections (if applicable), but the overall process should be less extensive than the initial registration.

Important Considerations:

• Changes to the Device: If there are any significant changes to the device (e.g., changes in design, intended use, or manufacturing process), these may need to be reported to BPOM, and a new registration may be required.
• Post-Market Surveillance: Even after the registration is approved, manufacturers must adhere to post-market surveillance obligations and report any adverse events or safety concerns related to the device.

In summary, the Class II medical device registration in Indonesia is valid for 5 years, and it needs to be renewed before the expiration date to maintain market access.

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