Domestic medical device distribution license
As the global demand for healthcare products continues to rise, countries are reinforcing regulatory measures to ensure that medical devices distributed within their borders meet specific standards. In Indonesia, and many other nations, a Domestic Medical Device Distribution License is a mandatory requirement for companies that wish to market and distribute medical devices produced locally. This license signifies regulatory compliance and ensures that the devices are safe, effective, and traceable.
Obtaining a domestic distribution license is not merely a formality it is a comprehensive process involving legal documentation, facility inspections, quality control systems, and technical responsibilities. Understanding the licensing process is critical for manufacturers, distributors, and stakeholders who aim to operate legally and competitively in the local healthcare market.
What Is a Domestic Medical Device Distribution License
A Domestic Medical Device Distribution License is an official permit granted by a country’s health regulatory authority, allowing a company to legally distribute locally manufactured medical devices within that jurisdiction. This license confirms that the company adheres to national laws regarding storage, transportation, sales, and post-market surveillance of medical devices.
In Indonesia, for example, the license is issued by the Ministry of Health (Kementerian Kesehatan RI) under the framework of Peraturan Menteri Kesehatan (Permenkes). It validates that a company has implemented CDAKB (Cara Distribusi Alat Kesehatan yang Baik or Good Distribution Practice for Medical Devices), which is a key compliance requirement for distribution.
Who Needs a Domestic Distribution License
Any company involved in the distribution of medical devices produced within the country must obtain a domestic distribution license. This includes manufacturers that also act as distributors, third-party logistics providers, and companies that function solely as intermediaries in the supply chain.
Even if a business does not directly manufacture medical devices, handling the logistics of locally produced equipment—such as warehousing, inventory management, or retail distribution requires this license. Exemptions are rare and typically limited to internal hospital use without any external sales or public distribution.
Legal Framework and Regulatory Authority
The issuance of domestic medical device distribution licenses is governed by specific laws and guidelines laid out by the regulatory authority in each country. In Indonesia, the relevant legal documents include Permenkes No. 14 Tahun 2021 and Regulation of the Minister of Health No. 4 Year 2014 on CDAKB implementation.
The Directorate General of Pharmaceuticals and Medical Devices (Ditjen Farmalkes) oversees the process and ensures compliance with both national and international standards. The licensing process is aligned with WHO recommendations and the ASEAN Medical Device Directive (AMDD), which seeks to harmonize device regulation in Southeast Asia.
Importance of the Distribution License
The domestic distribution license plays a vital role in ensuring the integrity, safety, and traceability of medical devices. It confirms that the company operates under a system that minimizes risk to public health while ensuring reliable product delivery.
Additionally, having a valid distribution license helps establish credibility with hospitals, clinics, and pharmacies. It also enables participation in public procurement systems, government tenders, and e-catalog listings such as Indonesia’s e-Katalog LKPP. Without the license, a company cannot legally market or distribute products, making it an indispensable part of regulatory compliance.
Key Requirements for Obtaining the License
To qualify for a domestic medical device distribution license, a company must meet a series of technical and administrative requirements. These include:
- A registered business entity with the proper business classification (KBLI code).
- A physical office and warehouse that complies with CDAKB standards.
- A designated Technical Person in Charge (PJT) with a relevant educational background (usually pharmacy, engineering, or health sciences).
- Standard Operating Procedures (SOPs) for storage, handling, delivery, and complaints.
- A documented Quality Management System (QMS) covering product traceability, recall procedures, and corrective actions.
- Inventory and distribution tracking systems, either manual or digital.
Each requirement is designed to ensure that products maintain their safety and performance from the point of manufacture to end-user delivery.
The Role of the Technical Person in Charge (PJT)
The Penanggung Jawab Teknis (PJT) or Technical Person in Charge plays a central role in securing and maintaining a distribution license. This individual must hold a degree in a related scientific field and have relevant experience in medical devices or quality assurance.
The PJT is responsible for overseeing compliance with CDAKB guidelines, maintaining documentation, conducting internal audits, and reporting to regulatory bodies. Their signature is often required on official documents, making them legally accountable for the company’s distribution operations.
Steps in the Application Process
Applying for a domestic medical device distribution license involves several key stages. The company must first prepare and gather all necessary documentation, including business permits, tax registration, facility blueprints, employee qualifications, and SOPs.
Once documents are complete, they are submitted online via the Sistem Perizinan Alat Kesehatan (SIPTIK) portal managed by the Ministry of Health. The next steps include:
- Document verification by the regulatory authority
- On-site inspection of the warehouse and operational offices
- Evaluation of staff roles and procedures
- Final decision and issuance of the license if all conditions are met
Processing times can range from a few weeks to several months, depending on the completeness of the submission and the authority’s backlog.
Facility Requirements and Inspection
The company must maintain a clean, organized, and secure warehouse for storing medical devices. The space should include separate zones for receiving, quarantining, storing, and dispatching goods. Environmental controls such as temperature and humidity monitoring are necessary for sensitive devices.
During the inspection, authorities assess whether the company has proper shelving, inventory systems, fire safety measures, and security protocols. They also ensure that all practices align with the CDAKB standard, and that the warehouse meets the specific needs of the types of devices being handled.
Documentation and Traceability Obligations
One of the pillars of regulatory compliance in medical device distribution is traceability. Companies must keep accurate and detailed records of all products moving in and out of their facility. This includes:
- Batch numbers
- Serial numbers
- Dates of receipt and delivery
- Destination addresses
- Customer information (hospitals, clinics, retailers)
This documentation is vital in the event of a product recall, complaint investigation, or regulatory audit. Failing to maintain traceability can lead to license suspension or revocation.
Validity and Renewal of the License
In most jurisdictions, including Indonesia, the domestic distribution license is valid for a period of five years, provided that the company continues to comply with regulatory requirements. However, annual reporting and periodic surveillance audits may be required.
Renewal involves resubmitting updated documents and undergoing a review of changes that may have occurred in the company’s operations, such as expansion, relocation, or personnel changes. Timely renewal is critical, as failure to maintain an active license can result in legal penalties and loss of market access.
Post-Licensing Compliance and Monitoring
Once licensed, the distributor must implement continuous monitoring and improvement programs. This includes:
- Regular internal audits
- Employee refresher training
- Handling product complaints and adverse events
- Conducting periodic reviews of SOPs
- Responding to regulatory updates and changes
The Ministry of Health may conduct unannounced inspections to verify that the company maintains its standards. Therefore, documentation must always be current, and staff should be aware of their roles in maintaining compliance.
Common Mistakes in the Licensing Process
Many companies, especially new entrants, face challenges when applying for a domestic medical device distribution license. Common errors include incomplete documentation, hiring under qualified PJTs, non-compliant warehouse layouts, and lack of understanding of CDAKB requirements.
To avoid these pitfalls, businesses are encouraged to consult regulatory experts, attend Ministry of Health workshops, and review official guidelines in detail. Pre-inspection checklists and mock audits are also useful tools to improve readiness and prevent costly delays.
Integration with E-Catalogue and Government Procurement
A domestic distribution license is often a prerequisite for listing products in the national e-catalogue, such as Indonesia’s e-Katalog LKPP. This listing is essential for participating in government procurement, hospital supply contracts, and public sector tenders.
Only companies with valid licenses and CDAKB certified facilities are eligible to enter these procurement platforms. Therefore, licensing is not just about legal compliance it is a strategic requirement for business growth in the public healthcare sector.
The Impact of Licensing on Business Reputation
Beyond regulatory necessity, holding a domestic distribution license enhances a company’s reputation in the market. It signals to healthcare providers, partners, and consumers that the company is committed to quality, safety, and professionalism.
Licensed companies are seen as trustworthy and reliable, which can open doors to new partnerships, exclusive distribution agreements, and access to high-value accounts such as national hospitals and private healthcare networks.
Future Trends and Digital Transformation
Regulatory authorities worldwide are moving toward digital licensing and monitoring systems. Platforms such as SIPTIK and e-Regalkes are examples of digital transformation in Indonesia’s health product regulation. These systems allow companies to track application status, submit updates, and report incidents online.
In the future, expect to see real-time license validation, QR-coded distribution certificates, and blockchain-based traceability solutions. Staying ahead of these trends will help businesses maintain compliance while improving operational efficiency.
A Domestic Medical Device Distribution License is an essential certification for any company handling the distribution of locally manufactured medical devices. It confirms regulatory approval, ensures patient safety, and enables access to the national healthcare supply chain. From facility requirements and documentation to audits and renewals, the licensing process demands careful planning, execution, and ongoing commitment to quality.
Companies that invest in understanding and complying with domestic licensing requirements not only fulfill legal obligations—they gain a competitive advantage in a growing and increasingly regulated industry. By prioritizing compliance, transparency, and operational excellence, businesses can secure their position in the domestic healthcare market and contribute to improved patient outcomes across the nation.
Contact Naramedic for further consultation.