On 16 June 2023, the Ministry of Health of the Republic of Indonesia (KEMKES) announced the application of the CPAKB certificate as the new requirement for local manufacturers in Indonesia. While earlier this year, CDAKB has been mandated for local distributors in Indonesia.
In accordance with the Ministerial Regulation (Permenkes) 20/2017:
- Section 2, Paragraph 1:
The application of the Good Manufacturing Practises of the Medical Devices certificate (CPAKB) or Good Manufacturing Practises of the Home Medical Supplies certificate (CPPKRTB) for medical device manufacturers and home medical supplies manufacturers to continue manufacturing.
- Section 2, Paragraph 2:
The application of the CPAKB certificate or CPPKRTB certificate, referring to the point above, must be proven with the certified certificates that have undergone the CPAKB audit or CPPKRTB audit.
- Section 2, Paragraph 3:
CPAKB and CPPKRTB as referred to in Paragraph (1) includes aspects of:
a) Quality management system;
b) Management responsibility;
c) Resource management;
d) Product realization; and
e) Measurement, analysis and improvement
- Section 4
Within four years after its promulgation, the ministerial regulation must be complied with by the medical device and home medical supply industries.
Therefore, starting on January 1, 2024, the CPAKB certificate will be compulsory in order to apply for the distribution of medical devices in Indonesia.
During the transitional period, domestic medical device distributor applications that are still in the process of submitting CAPKB certification in accordance with the scope of the device registered until 31 December 2023 will be granted a distribution permit validity period of 1 year and required to attach the CPAKB certificate in accordance with the scope of the registered product at the time the distribution permit is extended.