In the process of medical device registration in Indonesia, product labeling may appear to be a minor detail. In practice, however, it is one of the core focus areas reviewed by the Badan Pengawas Obat dan Makanan (BPOM) and one of the most common reasons for application rejection or delays in market entry.
According to applicable regulations—including the Law of the Republic of Indonesia Number 36 of 2009 Concerning Health, Regulation of the Minister of Health Number 62 of 2017, Law of the Republic of Indonesia Number 33 of 2014 on Halal Product Guarantee, and the ASEAN Medical Device Directive—medical device labeling must strictly follow four core principles:
- Bahasa Indonesia as the primary language
- Complete and accurate information
- Clear risk communication
- Full traceability
Additional requirements apply depending on the device risk classification, leaving little room for error.
This article outlines mandatory labeling requirements, classification-specific differences, and common pitfalls, helping manufacturers streamline compliance and avoid unnecessary delays.
I. Mandatory Requirements: Seven Essential Label Elements
Under Indonesia’s medical device regulations and BPOM guidance on labeling and Instructions for Use (IFU), all Class B, C, and D devices must include the following seven mandatory elements on the smallest sale unit label. Missing any one item may result in rejection.
1. Product Identification Information
Labels must be primarily in Bahasa Indonesia (English may be included additionally).
The product name must exactly match the registration documents, with clear indication of model and specifications to ensure consistency throughout the regulatory process.
2. Traceability Information
- Lot number (Lot No.) and Serial number (Serial No.) are mandatory
- For Class C and D devices, it is strongly recommended to include UDI (Unique Device Identification) to enhance traceability and recall efficiency
3. Responsible Entity Information
The label must include:
- Full legal name and address of the manufacturer
- Name and Indonesian address of the local representative/importer
- Clear designation such as “Importer” or “Distributor”
This ensures effective regulatory traceability.
4. Date Information
- Manufacturing date and expiry date must follow the format: DD/MM/YYYY
- For reusable devices, additional statements such as “Valid for X years after first use” should be included to avoid ambiguity
5. Product Status Information
- Sterile devices must include “STERIL” and specify the sterilization method (e.g., EO, irradiation, steam)
- Single-use devices must include “Hanya untuk Sekali Pakai” (single use only), along with internationally recognized symbols
6. Safety Warnings
- Contraindications and precautions must be clear and easy to understand
- For high-risk devices, critical warnings (e.g., life-threatening risks) should be highlighted in bold red text to ensure rapid recognition by healthcare professionals
7. Compliance Markings
- After approval, the NIE (distribution permit number) must be displayed
- If the product contains animal-derived materials, labeling must include “Tidak Mengandung Bahan Babi” (does not contain pork), and Halal certification issued by BPJPH may be required to comply with local religious regulations
II. Differences in Labeling Requirements for Class B, C, and D Devices
While general requirements apply to all classes, additional expectations are aligned with a risk-based regulatory approach.
Class B (Low–Moderate Risk)
- General labeling requirements are sufficient
- No additional risk emphasis required
- Complete and accurate traceability information is key
Class C (Moderate–High Risk)
- Additional risk-related information must be included
- Devices in contact with the human body (e.g., orthopedic implants) should include biocompatibility statements, such as compliance with ISO 10993
Class D (Highest Risk)
- Enhanced risk warnings are mandatory
- All potential risks and mitigation measures must be clearly described
- Implantable devices must include a patient identification card template
- UDI must support full lifecycle traceability, linking manufacturing and clinical data
III. Practical Considerations and Common Pitfalls
Based on industry experience, the following five key issues are among the most common causes of rejection by BPOM:
1. Language Compliance
Bahasa Indonesia must be the primary language.
Professional translation is strongly recommended to avoid inaccuracies caused by literal translation.
2. Label Durability
Labels must withstand intended use conditions, including sterilization and cleaning processes.
Information must remain legible, intact, and resistant to fading throughout the product lifecycle.
3. Consistency Across Documents
Label content must be fully consistent with:
- Registration application forms
- Technical documentation
- Instructions for Use (IFU)
Any inconsistency (e.g., product name, model, intended use) may lead to immediate rejection.
4. Pre-Reserved Space for Regulatory Codes
Information such as NIE number and UDI is assigned after approval.
Manufacturers should reserve space in advance to avoid redesign and delays.
5. Change Control Compliance
Any modification to label content (e.g., updates to warnings or product information) must be submitted to BPOM for approval before implementation.
Unauthorized changes may result in regulatory penalties.
Conclusion
In Indonesia, labeling compliance is fundamentally about alignment with regulations, localization, and meticulous attention to detail.
As the most visible representation of product compliance, labeling directly impacts both registration approval and market access.
Manufacturers are strongly advised to plan labeling strategies early in the registration process, ensuring alignment with regulatory requirements and device classification. Proactive preparation can significantly reduce approval timelines and minimize compliance risks.