Indonesia medical device post market requirements
Post-market obligations for medical devices in Indonesia include renewals, modifications, halal certifications, and post-market surveillance.
Overview of postmarket requirements for medical devices
Medical device companies must be proactive to ensure their registered devices remain compliant while on the Indonesian market. Post-market compliance requirements comprise renewing registrations, notifying regulatory authorities of any modifications to your device, maintaining halal compliance, and engaging in postmarket surveillance and vigilance reporting activities.
Renewals
Device registrations must be renewed every five years. To ensure your renewal is processed without interruption to your registration status, it’s important to begin the renewal proceedings at least nine months before your registration’s expiration date.
Modifications
Certain device changes or corrections can be submitted as a modification to the registration, such as:
- Size, including addition or reduction/removal of the quantity and/or size of the products
- Packaging (size, type, form, and materials)
- Labeling, such as: language, logo, and symbols (for example: the addition of halal logo, ISO, CE, or company logo), expiry date, product code or type, storage temperature, minor product name revision, changes in labeling design (color, picture, texts, layout)
- Accessories
- Name and address of authorized representative by the manufacturer, including:
- Change on name and address of legal manufacturer
- Change of legal entity
- Change on manufacturer address due to urban planning
- Change on manufacturer name if the address does not change
- Change on distributor name if Tax ID and business license does not change
- Typographical error information or writing on the license
Other device changes may require a new registration submission. Registration renewals and modification requests can be submitted at the same time.
Halal Product Assurance in Indonesia
In 2021, Indonesia introduced Government Regulation 39, which mandates halal certification for a range of products, including medical devices. Halal refers to ingredients, substances, or processes (such as manufacturing) that comply with Islamic law. Halal certification requirements for medical devices will become mandatory in a phased approach, with different deadlines for each class of medical device:
- Class A: October 17, 2026
- Class B: October 17, 2029
- Class C: October 17, 2034
The certification process includes an inspection of the device’s production site by an agency recognized by the Indonesia Halal Product Assurance Organizing Body (BPJPH).
Indonesia medical device post-market surveillance and vigilance
Medical device companies selling in Indonesia must conduct postmarket surveillance and report adverse events (AEs). Adverse events should be reported through the E-Watch platform according to the specified timelines:
- Within 48 hours if there is a serious threat to public health;
- Within 10 days if the event led to a death or serious deterioration of health;
- Within 30 days if the event could have led to a death or serious deterioration of health.
Indonesia’s vigilance requirements are largely harmonized with the ASEAN Medical Device Directive (AMDD).
Frequently
Asked Questions
Can non-halal devices be imported to Indonesia?
Yes, but they must be labeled accordingly.
How much does it cost to renew a medical device registration in Indonesia?
Renewals are IDR 1,000,000, which is approximately US $65, per device.
How much does it cost to modify a medical device registration in Indonesia?
Modifications are IDR 1,000,000, which is approximately US $65, per device. Combining a renewal and modification for a device can result in a reduced fee of IDR 1,500,000.
