"Unsafe and unqualified products will not have a distribution permit. The parties involved will be subject to legal sanctions for the existence of such products," the ministry's Director of Medical Device Supervision, Eka Purnamasari, stated on Tuesday.
Currently, several medical devices are being offered at lower prices. Hence, she suggested the public to pay closer attention and to only buy registered products that have passed evaluation by the Ministry of Health and have a distribution permit to ensure the product quality.
She remarked that health-related products are strictly regulated in Indonesia owing to being related to risks to health.
In addition, the government is responsible for ensuring that pharmaceutical products and medical devices used by the public and health service facilities are safe, of high quality, and useful, as stipulated in Health Law Number 17 of 2023 concerning Health.
"Later, medical devices that have been evaluated can be declared legal for circulation in Indonesia with a distribution permit or registration number from the Ministry of Health," she added.
She explained that with regard to distribution permits, imported products usually start with three letters, namely AKL, followed by a number, which means they have been registered by the Ministry of Health.
Meanwhile, domestic products also start with the three letters AKD and then followed by a number, Purnamasari remarked.
"The public can also check the registration through the medical equipment mobile application," she stated.
On the other hand, she noted that paying attention to distribution permits can also help people to avoid illegal medical devices.
Other preventive steps are by paying attention to the trade name or brand, product type, batch number, production code, and the name and address of the manufacturer, she remarked.
In addition, the public should pay attention to the medical device distributor, intended use, instructions for use, expiry date of the product, and the condition of the medical device to avoid non-suitable products.
"Regarding the potential for improper products, we also monitor products that are no longer suitable for use by supervising their destruction," Purnamasari remarked.
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Translator: Lia Wanadriani S, Resinta Sulistiyandari
Editor: Rahmad Nasution
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