Getting your product registered in Indonesia is a huge milestone—but it’s definitely not the finish line. Think of registration as the starting pistol signaling the real race ahead. To keep your product compliant and your business thriving, here are the crucial steps you need to focus on after approval.
1. Label Verification for Every Batch
Every time you print a new batch of labels, double-check the essentials:
- Correct Notifikasi Number (for cosmetics) or NIE (for medical devices)
- Accurate distributor details
- Clear and correct expiration dates
Even a tiny misprint can trigger a costly market recall or shipment hold. Staying vigilant here saves headaches down the line.
2. Regular Post-Market Reporting
Compliance doesn’t end at approval—it’s ongoing.
- Cosmetics: You need to submit summaries of consumer complaints every 6 to 12 months to BPOM.
- Medical Devices: The Ministry of Health requires regular incident reports and logs of any adverse events associated with your devices.
Consistent reporting helps demonstrate your commitment to safety and keeps regulators confident in your brand.
3. Handle Variations & Renewals on Time
Product updates and license renewals are part of the game:
- Even minor formula tweaks, like changing a preservative, usually require a new notification or approval.
- For medical devices, NIE and IDAK licenses must be renewed every 5 years. Start preparing at least six months before expiration to avoid interruptions in import or distribution.
Planning ahead means no surprises that could stall your sales.
4. Market Surveillance & Audits
BPOM and Kemenkes inspectors don’t always announce their visits.
- Conduct regular internal audits of your product storage conditions, distribution records, and label accuracy.
- Be ready to show that you’re maintaining standards consistently.
This proactive approach keeps you inspection-ready and builds trust with regulators.
Final Thought Think of regulatory compliance not as a one-time checkpoint, but as a continuous journey. Ongoing vigilance and adherence to post-approval obligations are your best tools to safeguard your brand’s reputation and secure your market share in Indonesia
Do you need assistance registering your product in Indonesia?
Contact us today to start your registration process.