Indonesia’s medical device industry has demonstrated significant growth, bolstered by government initiatives to strengthen the national pharmaceutical and healthcare sectors.
With export values reaching USD 591.72 million in 2024, Indonesian manufacturers are increasingly looking beyond domestic borders to markets in Singapore, the United States, and the European Union. However, understanding the intersection of healthcare regulations and international trade laws is essential for a smooth global expansion.
Legal Framework Governing Medical Device Exports
Exporting medical devices from Indonesia requires adherence to a dual-regulatory regime overseen by the Ministry of Health and the Ministry of Trade. The primary legal basis for healthcare standards is Minister of Health Regulation No. 11/2025 on Business Activity Standards and Product/Service Standards in the Implementation of Risk-Based Business Licensing for the Health Subsector (“Permenkes 11/2025“).
Under this regulation, any medical device produced or circulated, including those intended for export, must meet rigorous safety, quality, and benefit standards. A critical requirement is the Certificate of Free Sale (CFS). As stipulated in the guidelines, a CFS is an official statement from the competent authority affirming that the medical devices, in vitro diagnostic devices, and household health supplies (PKRT) have obtained a distribution permit and may be freely traded in the country of origin.
The Ministry of Trade also governs the international flow of goods under Law No. 7/2014 concerning Trade (“Trade Law“). Article 38, paragraphs 1 and 2 of the Trade Law stipulate:
Paragraph 1: The government shall regulate foreign trade activities through policies and controls in the fields of Export and Import.
Paragraph 2: Foreign trade policies and controls as referred to in paragraph (1) are directed toward: a. increasing the competitiveness of Indonesian export products; b. increasing and expanding access to markets abroad; and c. increasing the capability of Exporters and Importers so that they become reliable business actors.
Production and Quality Requirements Prior to Export
Quality assurance is a critical factor in medical device exports. Importing countries typically require compliance with international standards, particularly ISO 13485, which governs quality management systems for medical devices.
Implementation of ISO 13485 provides several strategic benefits:
- Ensuring compliance with international regulatory requirements
- Enhancing product safety through systematic risk control
- Strengthening corporate credibility among regulators and business partners
- Facilitating entry into global markets where certification is mandatory
- Improving operational efficiency and production consistency
In Indonesia, production quality compliance is implemented through Cara Pembuatan Alat Kesehatan yang Baik (CPAKB), or Good Manufacturing Practices for Medical Devices. CPAKB governs raw material control, manufacturing processes, packaging, and product storage based on Article 1 paragraph (2) of Minister of Health Regulation No. 20/2017 on Good Manufacturing Practices for Medical Devices and Household Health Supplies (“Permenkes 20/2017”).
Compliance with CPAKB serves not only as an administrative requirement but also as proof of product safety and reliability for international markets.
Export Documentation and Destination Country Compliance
Exporters must prepare both administrative and technical documentation. Administrative documents typically include:
- Commercial invoice
- Packing list
- Goods Export Notification (PEB)
- Customs documentation
- Certificate of Origin (COO) to obtain preferential tariffs under free trade agreements
Technical documentation generally includes product quality certificates, laboratory test reports, and technical dossiers used by importing-country regulators to assess product safety and suitability.
Exporters must also ensure consistency between product data, Harmonized System (HS) classification codes, and export destination details. Inaccurate product classification or documentation inconsistencies may trigger customs inspections and export delays.
For digital processing of export-import services, businesses should utilize the official Ministry of Health portals at regalkes.kemkes.go.id or esuka.binfar.kemkes.go.id.
Compliance with Importing-Country Regulations
Medical device exporters must conduct thorough regulatory due diligence in destination markets.
For example:
- Exports to the United States must comply with Food and Drug Administration (FDA) regulations, including product classification and registration.
- Exports to the European Union must comply with Medical Device Regulation (MDR) and CE Marking certification requirements.
Exporters may need to adjust product specifications, labeling, language requirements, and technical documentation to comply with foreign regulatory frameworks. Failure to meet destination-country requirements may result in product rejection or market withdrawal.
Also read: Precision Medicine: The Future of Personalised and Effective Healthcare in Indonesia
Building a Sustainable Export Compliance Strategy
Medical device exports represent a strategic opportunity for Indonesia’s healthcare manufacturing sector to strengthen global competitiveness. However, successful export activities require integrated compliance with domestic licensing regulations, international quality standards, and destination-country legal requirements.
Companies are encouraged to adopt comprehensive compliance strategies, conduct regulatory due diligence, and maintain robust documentation systems. These measures help minimize legal risk, facilitate customs clearance, and strengthen corporate credibility in international markets.***
Also read: The Legal Framework for Digital Twin Technology in Indonesian Healthcare Services
Regulations:
- Undang-Undang Nomor 7 Tahun 2014 tentang Perdagangan (“UU Perdagangan”).
- Peraturan Menteri Kesehatan Nomor 20 Tahun 2017 tentang Cara Pembuatan Alat Kesehatan dan Perbekalan Kesehatan Rumah Tangga yang Baik (“Permenkes 20/2017”).
- Peraturan Menteri Kesehatan Nomor 11 Tahun 2025 tentang Standar Kegiatan Usaha dan Standar Produk/Jasa Pada Penyelenggaraan Perizinan Berusaha Berbasis Risiko Subsektor Kesehatan (“Permenkes 11/2025”).
References:
- Wamendag Dorong Ekspor Alat Kesehatan ke Pasar Global. Hipelki. (Diakses pada 30 Januari 2026 pukul 09.45 WIB).
- Pedoman Ketentuan Ekspor dan Impor Alat Kesehatan, Alat Kesehatan Diagnostik In Vitro dan Perbekalan Kesehatan Rumah Tangga. Regalkes Kemenkes. (Diakses pada 30 Januari 2026 pukul 10.03 WIB).
- ISO 13485: Sistem Manajemen Mutu Peralatan Medis – Pengertian, Manfaat, dan Proses Sertifikasi. ACS Indonesia. (Diakses pada 30 Januari 2026 pukul 10.24 WIB).
- Persyaratan Mutu Peralatan Medis Amerika Serikat. Lamansitu Kemendag. (Diakses pada 30 Januari 2026 pukul 11.02 WIB).