Our Services
Medical Device Notification
About this service
Medical Device Notification is one category of medical devices that must be registered and is also an important process to ensure that medical device products circulating in Indonesia meet the standards and regulations of the Ministry of Health. Manufacturers or importers are required to submit product-related information, including technical specifications and usability. Naramedic is ready to provide guidance and support in every stage of the notification, from document collection to submission. With experience and a tailored approach, we help ensure the notification process runs smoothly, allowing you to focus on product development and marketing.
What you get
Full assistance in the low-risk medical device notification process according to Ministry of Health regulations.
Preparation and review of documents to meet notification requirement standards.
Faster processing time estimate compared to AKD/AKL registration.
Direct access to an experienced team of regulatory affairs consultants.
Regular updates on the notification submission status until the official notification number is issued.
Further consultation for product development and preparation if proceeding to higher-risk registration.
