A certificate is proof of a medical device that the product is eligible for import or export. The certificate is also one of the requirements that must be possessed by a medical device to be marketed in Indonesia. There are various kinds of certificates and each has its own purpose and function, such as a Product Information Certificate, which contains detailed information about the product.
Making a certificate has a fairly complicated process. The documents needed in a certificate application are not small. The approval time for the certificate application is 7 working days. A certificate application may fail if the required documents are lacking or do not meet the requirements. If the required documents are lacking, the distributor can complete the missing documents within 7 working days. If it exceeds this time, the application will be rejected.
As for the cost of Non-Tax State Revenue (PNBP) in the application process, the type of certificate has a different PNBP fee.
DERAY CERTIFICATE SERVICES
With our experience in medical device registration since 2009, we are willing to assist you in obtaining various medical device certificates. We assist clients in obtaining product approval through good submission practices. Many companies have trusted our services in marketing medical devices.
We are a group of professionals from multinational medical device manufacturers who specialize in product registration both at home and abroad. We are PT. Deray Global Utama, and are dedicated to helping clients efficiently navigate the medical device registration system with high regulatory compliance.
The following is a list of types of certificates with time of approval, PNBP, and their validity period:
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