What an AKL Number Really Means
In the medical device industry, regulatory compliance is not just a box to check it’s a critical part of ensuring patient safety and product quality. In Indonesia, one of the most important elements in the regulatory framework for medical devices is the AKL number. For manufacturers, importers, healthcare providers, and even consumers, understanding what an AKL number really means is key to navigating the healthcare product landscape.
The AKL number, often found on product labels, is more than just a random string of digits. It is a legal requirement and a symbol of a device’s approval by Indonesia’s Ministry of Health. This article explores the true meaning of the AKL number, how it’s issued, what it represents, and why it matters for everyone involved in the handling or usage of medical devices in Indonesia.
Understanding the Basics of the AKL Number
The term “AKL” stands for “Alat Kesehatan Layak Edar”, which translates to “Medically Approved Device” in English. The AKL number is a unique registration number issued by the Ministry of Health of the Republic of Indonesia (Kementerian Kesehatan RI). It certifies that a medical device has passed the evaluation process and is authorized for distribution and sale in the Indonesian market.
This number indicates that the product meets the safety, quality, and performance standards set by the government. It is issued only after a thorough review of technical documents, risk assessments, manufacturing quality, labeling, and sometimes even local clinical data. Without an AKL number, a product is not legally allowed to be sold in Indonesia.
What the AKL Number Represents
The presence of an AKL number on a medical device signifies regulatory clearance and governmental approval. This approval process evaluates not just the product’s intended use, but also its technical specifications, manufacturing processes, and packaging. It ensures that the product is suitable for Indonesian healthcare conditions and aligns with public health priorities.
An AKL number serves as a mark of legitimacy and a layer of assurance for end users. It reflects that the product has been reviewed for compliance with all applicable standards. In short, it is Indonesia’s official stamp of approval that guarantees the product can be trusted in clinical settings.
How an AKL Number Is Structured
Although the structure of the AKL number may appear random at first glance, it actually follows a systematic format that includes numerical sequences and codes that help identify the device and its approval details. Generally, the number includes digits that reflect the year of approval, the product classification, and the order of registration.
Understanding this structure allows regulatory professionals and businesses to trace the registration timeline of a product. While this information isn’t always necessary for consumers, it provides value to industry stakeholders when reviewing regulatory status, market trends, or certification renewals.
The AKL Number Versus Other Registration Numbers
In global terms, the AKL number is similar to the FDA registration number in the United States or the ARTG number in Australia. While each country has its own regulatory system, the AKL number plays the same role within Indonesia’s healthcare ecosystem.
It’s also important to distinguish the AKL number from the AKD number—which is issued to locally manufactured devices—or AKL-Non-Active, which applies to devices that no longer meet active marketing conditions. The AKL is specifically issued for imported devices that meet all current regulatory requirements.
The Role of the AKL Number in Market Access
For foreign manufacturers aiming to enter the Indonesian market, obtaining an AKL number is non-negotiable. It is the gateway to commercializing products legally. Without it, even if a product is approved in the U.S., EU, or Japan, it cannot be sold in Indonesia.
The process requires a local distributor or regulatory agent who is recognized by the Ministry of Health. This entity acts as the product license holder (sometimes referred to as a “Marketing Authorization Holder”) and is responsible for the registration, post-market surveillance, and communication with authorities.
The Application Process for an AKL Number
The journey to obtaining an AKL number involves multiple steps, starting with product classification. Depending on the device’s level of risk, it may be classified as Class A (low risk), B (moderate risk), C (high risk), or D (very high risk). This classification determines the complexity and documentation needed for the application.
Applicants must submit a range of documents including product specifications, testing reports, labeling, instructions for use, certificates of analysis, and proof of Good Manufacturing Practice (GMP). In some cases, clinical evaluation reports or third-party certifications such as CE or FDA clearance may also be required.
Timeframe and Validity of the AKL Number
Once submitted, the registration process may take anywhere from a few weeks to several months, depending on the product’s class and the completeness of the documentation. High-risk devices typically require more scrutiny and therefore take longer to process.
Once granted, an AKL number is valid for five years, after which it must be renewed. It’s essential for companies to monitor expiration dates and submit renewal applications on time to avoid interruption in product distribution or legal issues.
Verifying an AKL Number
The Indonesian Ministry of Health provides a public database where users can verify AKL numbers. By visiting https://infoalkes.kemkes.go.id, anyone can input the product name or AKL number to check its validity. The search results show details such as the license holder, product classification, and registration status.
This tool is particularly useful for procurement teams in hospitals, importers reviewing potential suppliers, or consumers looking to confirm that the product they are using is genuine. Verifying an AKL number helps combat counterfeit medical devices and ensures public safety.
Responsibilities of AKL License Holders
Holding an AKL number comes with significant responsibilities. The license holder must ensure the product continues to meet regulatory standards throughout its lifecycle. This includes maintaining records, reporting adverse events, managing complaints, and coordinating product recalls if necessary.
Any changes to the device, such as modifications in design, packaging, or labeling, must be reported to the Ministry of Health. In some cases, changes may require a new AKL application or amendment of the existing one.
Post-Market Obligations Linked to AKL
Having an AKL number doesn’t end at approval it continues with post-market obligations. License holders must monitor the performance of their products, collect feedback, and act swiftly if any risk is identified. This may involve sending reports to the Ministry or updating the product’s technical file.
Post-market surveillance ensures that products remain safe and effective throughout their use. It is an integral part of Indonesia’s effort to maintain high-quality standards and protect healthcare workers and patients alike.
What Happens If a Device Lacks an AKL Number
If a medical device is found in the market without an AKL number, it is considered illegal under Indonesian law. This can result in confiscation of the product, fines, license revocation, and even blacklisting of the company involved.
For hospitals, clinics, or pharmacies, using or selling unregistered products can jeopardize patient safety and legal standing. That’s why due diligence in sourcing only AKL-registered products is critical.
Common Challenges in Obtaining AKL Numbers
Many companies face challenges when applying for an AKL number. These include incomplete documentation, translation errors, missing product test data, or an unclear product classification. For foreign companies unfamiliar with Indonesian regulations, the process can be even more daunting.
To mitigate these challenges, businesses often work with local regulatory consultants or distributors who specialize in medical device registration. Their expertise helps reduce delays and ensures smoother communication with the Ministry of Health.
How AKL Fits into the Larger Regulatory Landscape
The AKL number is part of a broader framework of regulations that govern the healthcare industry in Indonesia. It works alongside guidelines for Good Distribution Practices (CDAKB), licensing of importers, labeling standards, and quality assurance protocols.
By integrating the AKL into a wider compliance strategy, companies can align more effectively with both local and ASEAN-wide health policies. As Indonesia continues to improve its regulatory systems, the AKL number remains a central component of device governance.
The Future of AKL and Regulatory Innovation
Indonesia’s regulatory environment is evolving with digital transformation. Efforts are underway to digitize the entire registration process and integrate AKL numbers into e-catalog platforms, procurement systems, and hospital management software.
In the future, we can expect to see QR code integration on packaging linked to the AKL number, real-time updates in national databases, and harmonization with ASEAN Medical Device Directives. These developments will make the AKL number even more crucial in ensuring transparent and efficient access to medical technologies.
Why Consumers Should Care About the AKL Number
Even though the AKL number is primarily a regulatory tool, consumers also benefit from its existence. By checking for an AKL number, patients and caregivers can confirm they are using safe, government-approved medical devices. It’s a way to empower public health decision-making at the individual level.
Whether you’re buying a blood pressure monitor, glucose meter, or face mask, looking for the AKL number helps reduce the risk of using counterfeit or uncertified products. In times of health crises or pandemics, this awareness can literally be life-saving.
The AKL number is far more than a bureaucratic formality it is a critical part of Indonesia’s healthcare safety net. It confirms that a medical device has been thoroughly reviewed, approved, and deemed safe for use. For manufacturers, it’s a legal gateway to market access. For distributors and hospitals, it’s a trust signal. For consumers, it’s a line of defense against harmful products.
Understanding what an AKL number really means empowers all stakeholders to make better, safer, and more informed decisions. As the medical device industry continues to grow and innovate, the importance of robust, transparent, and accessible regulatory systems like the AKL numbering system will only increase.
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