There are several key steps involved in registering a BPOM for diagnostics in Indonesia, and the following are the possible key steps in the general registration process:
Preparation of registration documents: Collect and prepare complete registration documents, including product specifications, technical documents, quality control and production process descriptions, laboratory test reports, etc.
Statutory Person Designation: Appoint a qualified legal person in Indonesia to represent your company in Indonesia for registration and regulatory matters.
Submit the registration application: Submit the complete registration documents to the Indonesia BPOM to initiate the approval process of the registration application.
Documentation review and technical assessment: The health department will conduct a review and technical assessment of the registration documents to ensure that the product meets hygiene and safety standards. There may be a range of questions and feedback that need to be responded to in a timely manner.
Lab Testing: If the product requires lab testing, make sure these tests are done during the registration process. Laboratory tests may include physical, chemical, microbiological, and other tests.
Pay the registration fee: Pay the corresponding registration fee, including the registration application fee, document examination fee, etc. Ensure that the payment process is completed in accordance with the regulations of the Indonesian BPOM.
Technical meetings: Attendance at technical meetings may be required to answer questions from the health department about the product or to provide additional information. This is an opportunity to exchange ideas and clarify questions.
Certificate of Registration Issuance: Once the registration application is approved, wait for the issuance of the Certificate of Registration. The Certificate of Registration is your license to sell your products in the Indonesian market.
Regulation and Update: After obtaining the Certificate of Registration, ensure that the product is regulated in accordance with regulatory requirements. At the same time, the renewal process should be initiated before the registration certificate expires to ensure that the product continues to be compliant.