Certificate of Production for Medical Devices and PKRT
A Production Certificate is a primary requirement for manufacturing Medical Devices, In Vitro Diagnostic Medical Devices, and Household Health Supplies (PKRT). According to the Indonesian Ministry of Health Regulation No. 1189/Menkes/Per/VIII/2010 on the production of medical devices and household health supplies, only companies that have a production certificate/standard certificate are allowed to manufacture these products, meaning that production must comply with the Good Manufacturing Practice (GMP) for Medical Devices.
The classification of the Production Certificate is based on the results of factory inspections for compliance with the GMP for Medical Devices or PKRT as stipulated by law. Depending on the manufacturing eligibility and the risks posed by the medical devices, production certificates for medical devices are classified into three categories: Class A, B, and C, as follows:
- Class A Medical Device Production Certificate: Granted to factories that have fully implemented GMP for Medical Devices, allowing them to produce Class I, Class IIa, Class IIb, and Class III medical devices.
- Class B Medical Device Production Certificate: Granted to factories eligible to produce Class I, Class IIa, and Class IIb medical devices according to GMP for Medical Devices.
- Class C Medical Device Production Certificate: Granted to factories eligible to produce certain Class I and Class IIa medical devices according to GMP for Medical Devices.
Similarly, PKRT production certificates are classified into three categories:
- Class A PKRT Production Certificate: Granted to factories that have fully implemented GMP for PKRT, allowing them to produce Class I, Class II, and Class III PKRT.
- Class B PKRT Production Certificate: Granted to factories eligible to produce Class I and Class II PKRT according to GMP for PKRT.
- Class C PKRT Production Certificate: Granted to factories eligible to produce certain Class I and Class II PKRT according to GMP for PKRT.
Reference:
Regulation of the Minister of Health Number 1189/MENKES/PER/VIII/2010 of 2010 concerning the Production of Medical Devices and Household Health Supplies
https://regulasi.bkpk.kemkes.go.id/detail/860cba8b-cb6e-4e5c-bedc-b008737a91a6/unduh/