Medical Device Registration in Indonesia
Regulatory authority: In Indonesia, medical devices are regulated by the Directorate General of Pharmaceutical and Medical Devices under the Ministry of Health (MOH). Medical products, whether they are manufactured or imported into Indonesia, must be registered with the MOH.
Classification: Medical devices in Indonesia are divided into three classes (I, II and III) based on risk level, with Class I being the lowest risk and Class III the highest risk.
To register a medical device, a company must have an office or a local distributor in Indonesia registered with the MOH.
Timeframe of registration: Medical devices are registered according to class within 30, 60, or 90 working days after the pre-registration process is complete.
Length of license: Licenses issued in Indonesia expire within 2-5 years, depending on the period of the Letter of Authorization.
As of 2012, Arazy Group now offers our new service, LICENSALE.COM™. This unique, cloud-based application provides you, the medical or IVD device manufacturer, with a comprehensive service that results in the successful registration of your product in Indonesia and ownership of the registration license through your company.
Once you register in Indonesia through LICENSALE.COM™, a global compliance profile is generated that easily facilitates the registration of your product in more than 80 countries around the world. LICENSALE.COM™ creates a foundation that makes registration simpler, faster, and more cost-effective than any alternative available today.
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