Looking to Import Medical Devices? Learn the Key Rules with IOR Service for Medical Devices Indonesia

Corporate Secretary Service Indonesia – If your company is planning to import medical equipment into Indonesia, understanding the local requirements is absolutely essential. Many healthcare businesses and distributors rely on an IOR service for medical devices Indonesia to navigate these rules efficiently. After all, medical devices are critical for improving patient care, introducing new technologies, and filling gaps where local production does not yet meet demand.

But Indonesia does not take medical device imports lightly. The government has set rigorous standards to protect public health, requiring imported products to meet strict safety, quality, and benefit criteria. These regulations ensure that only thoroughly evaluated and approved devices reach hospitals, clinics, and patients.

This commitment to high standards is firmly rooted in Indonesian law. According to Law No. 36 of 2009 on Health, Article 106 paragraph (1), both pharmaceuticals and medical devices can only be circulated in the market after obtaining a valid distribution permit. Without this permit, importing or selling medical devices simply isn’t allowed.

Types of Permits You’ll Need

The distribution licensing process for medical devices falls under the Ministry of Health, specifically through the Directorate General of Pharmaceuticals and Medical Devices. Before you receive any kind of distribution permit, your imported products must undergo a thorough assessment. This evaluation checks whether the medical devices comply with Indonesia’s established benchmarks for safety, effectiveness, and overall quality.

Once a product passes this careful review, it is granted a distribution permit. This official document means the product has been recognized as safe to use and beneficial for preventing, diagnosing, treating, or managing health conditions.

In Indonesia, the types of distribution permits generally include:

• New Applications: for entirely new products entering the market.
• Extension Applications: to renew an existing permit.
• Change Applications: when modifying product details or packaging.
• Extension with Changes: combining both renewal and product modifications.

Working with an experienced IOR service for medical devices Indonesia can help you handle these applications correctly and avoid costly delays or compliance issues.

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Certificates You Might Need

The Directorate of Medical Device Assessment and PKRT also issues several certificates that play a vital role in the importation process. These documents confirm that your products have been inspected and meet Indonesia’s regulatory standards. Some of the common certificates include:

• Certificate of Free Sale
• Certificate of Exportation
• Import Certificate for samples, raw materials, or spare parts
• Research Use Only (RUO) Certificate
• Import Approval Recommendation Letter
• Clinical Trial Approval Letter
• Halal certification for applicable products
• Various promotional and advertising approvals

By securing the right certificates, manufacturers and distributors provide crucial assurance to both the authorities and the public that their products are reliable and safe. It’s also a key step in building long-term trust in your brand.

Making the Import Process Easier

Looking at all these layers of regulation, it’s clear that importing medical devices into Indonesia is a serious process that demands attention to detail. From securing distribution permits to managing multiple certificates, each step is designed to uphold public health standards. This is where partnering with a dedicated IOR service for medical devices Indonesia like PortCorp can make a huge difference. By trusting experts who know the local regulations inside and out, you can streamline the entire process, avoid administrative setbacks, and ensure your products reach the market quickly and compliantly.

So if you’re ready to expand your business into Indonesia’s growing healthcare sector, take the time to do it right. Get the proper guidance, meet the requirements, and you’ll be well on your way to building a successful presence in one of Southeast Asia’s most dynamic medical markets. So, don’t worry about developing your business by setting up a company in Indonesia, because Portcorp is here as a solution for your business, also when you need IOR service for medical devices Indonesia. Portcorp is your comprehensive corporate secretary service in Indonesia. With our presence, you can get a dedicated company secretary to support you to what you need. Our company secretaries will track deadlines and file paperwork so your business keeps running smoothly. Contact us now on +6221-5020-8090 for your business succeed in the future!