Medical Product Registration Requirements in Indonesia

1. Regulatory Authority and Legal Framework

Medical product registration in Indonesia is primarily managed by the National Agency of Drug and Food Control (BPOM) under the Ministry of Health. The process is governed by various regulations, including those aligned with ASEAN harmonization efforts for medical devices and pharmaceuticals. All products intended for distribution must obtain marketing authorization before being placed on the market. https://www.cekindo.com/blog/medical-product-registration-indonesia

2. Categories of Medical Products Covered

The registration requirements apply to:

• Medical devices (Class A to D based on risk)
• Pharmaceuticals (prescription and over-the-counter drugs)
• Cosmetics
• Food supplements and traditional medicines (jamu)

Each category has specific guidelines, but all require local representation and BPOM approval. https://www.cekindo.com/blog/medical-product-registration-indonesia

3. Mandatory Local Representation

Foreign manufacturers cannot register products directly. A local company (PT PMA or local distributor) must act as the license holder and submit the application. This entity handles all interactions with BPOM, post-market surveillance, and adverse event reporting. Establishing or partnering with a local entity is a prerequisite. https://www.cekindo.com/blog/medical-product-registration-indonesia

4. Classification and Risk-Based Approach

Medical devices are classified into four risk classes (A–D), similar to ASEAN MDD:

• Class A: Low risk
• Class B: Low-moderate risk
• Class C: Moderate-high risk
• Class D: High risk

Higher classes require more extensive documentation, including clinical data and quality system certification (e.g., ISO 13485). https://www.cekindo.com/blog/medical-product-registration-indonesia

5. Key Documentation Requirements

Common documents across categories include:

• Application form and power of attorney
• Product composition/formulation
• Manufacturing process description
• Stability data
• Labeling in Bahasa Indonesia
• Free Sale Certificate from country of origin
• Certificate of Analysis
• Good Manufacturing Practice (GMP) or equivalent certification

For medical devices, the ASEAN Common Submission Dossier Template (CSDT) is often used. https://www.cekindo.com/blog/medical-product-registration-indonesia

6. Registration Process and Timelines

The typical steps are:

1. Appoint local agent/license holder
2. Prepare and submit dossier to BPOM
3. BPOM administrative and technical evaluation
4. Payment of fees
5. Issuance of marketing authorization (NIE for drugs/cosmetics, SDAK for devices)

Timelines vary: 6–24 months depending on class and completeness of submission. Expedited pathways may apply for priority products. https://www.cekindo.com/blog/medical-product-registration-indonesia

7. Post-Registration Obligations

After approval:

• Annual renewal for certain products
• Pharmacovigilance and adverse event reporting
• Compliance with labeling, advertising, and distribution rules
• Maintenance of updated technical files
• Readiness for BPOM inspections https://www.cekindo.com/blog/medical-product-registration-indonesia

Proper registration ensures legal market access in Indonesia’s growing healthcare sector while protecting public health through stringent oversight. https://www.cekindo.com/blog/medical-product-registration-indonesia