The specific requirements for the Indonesian Ministry of Health (MOH) registration certificate may vary depending on the medical product and situation. Typically, if a medical product is manufactured through a foundry, then the MOH registration certificate needs to include information about the foundry. Here are some considerations on the subject:
Compliance requirements: In Indonesia, the manufacturing and distribution of medical products is strictly regulated. The MOH registration certificate usually needs to include all relevant information about the manufacturing of the medical product, including the name and address of the foundry, the quality management system, and the production process. This helps to ensure the quality and compliance of the product.
Quality control and traceability: In the medical field, traceability is very important so that in the event of a problem or recall, it can be traced back to the manufacture of the product**. If the foundry's information is not included in the MOH registration certificate, it may be difficult to accurately trace back to the responsible party in the event of a product quality or safety issue.
Regulations and Policies: The requirements for the MOH registration certificate are formulated in accordance with Indonesian regulations and policies. If regulations and policies require the inclusion of foundry information on the registration certificate, then medical product manufacturers are often required to comply with these regulations.
Notifications of Updates and Changes: If the foundry information changes, the manufacturer is usually required to notify MOH in a timely manner and renew its registration certificate. This helps to maintain the accuracy and compliance of the registration certificate.
In general, usually, the Indonesian MOH registration certificate needs to contain foundry information related to the manufacturing of medical products to ensure the compliance, quality and safety of the products. If you are a medical product manufacturer and your products are manufactured through a co-pack, it is recommended that you follow local regulations and policies to ensure that the information on your registration certificate is accurate and compliant. If you have questions or need further guidance, you can consult the Indonesian Ministry of Health or the relevant regulatory authorities for detailed information and accurate guidance.