The post-pandemic era has seen an increased demand for medical devices in Indonesia, leading to the creation and revitalization of the medical device industry ecosystem. Referring to Law Number 11/2020 concerning Job Creation, Article 106 states, "Any person who produces and/or distributes pharmaceuticals and medical devices must obtain Business Licensing from the Central or Regional Government, in accordance with their authority based on norms, standards, procedures, and criteria set by the Central Government." Therefore, every manufacturer and distributor of medical devices must comply with the following regulations:

• Government Regulation No. 5 of 2021 on Risk-Based Licensing Implementation

• Minister of Health Regulation No. 14/2021 on Business Activities and Product Standards in Risk-Based Licensing for the Health, Pharmaceutical, Medical Devices, and Household Health Supplies Sectors (OSS-RBA)

• Investment Coordinating Board (BKPM) Regulation No. 3 of 2021 on Integrated Risk-Based Business Licensing Systems electronically

• Investment Coordinating Board (BKPM) Regulation No. 4 of 2021 on Guidelines and Procedures for Risk-Based Business Licensing Services and Investment Facilities

Business licensing includes:

• NIB (Business Identification Number)/Standard Certificate/Industrial License for Medical Devices from OSS-RBA

• Appropriate KBLI (Standard Classification of Indonesian Businesses) according to the produced products

• Application letter for CPAKB certification

• Identity of the authorized representative (ID card, diploma, full-time work statement, cooperation agreement letter) according to Minister of Health Regulation No. 14 of 2021

• Company's location coordinates as per data in OSS-RBA

• Medical Device Production Certificate (for existing manufacturers; not mandatory)

• ISO 13485 with production scope (if available; not mandatory)

Facilities and infrastructure should be accompanied by photo attachments, as well as the latest electronic medical device production report (e-report) for existing manufacturers. Currently, there are 815 Medical Device Manufacturing Companies in Indonesia, of which 191 have obtained the CPAKB (Good Medical Device Manufacturing Practices) Certificate. According to the Ministry of Health's policy as of May 2023, Medical Device Manufacturers registering domestically produced Medical Device products (AKD registration) must provide a CPAKB commitment. Starting January 1, 2023, Medical Device Manufacturers registering domestically produced Medical Device products (AKD registration) must already possess a CPAKB. Based on the risks involved, the majority of Medical Device Manufacturers in Indonesia produce Low-to-Medium-Risk Medical Devices (Class A and Class B).

PT INSPIRY INDONESIA KONSULTAN is here for you, as a reliable partner, to provide assistance in obtaining the CPAKB certification for IN-VITRO DIAGNOSTIC MEDICAL DEVICE MANUFACTURERS. Our support services include:

1. Preparation of legal documents

2. Preparation of 48-50 Standard Operating Procedures and over 100 forms

3. Work assistance socialization

4. Internal Audit socialization

5. Internal Audit assistance

6. Open-Closing CAPA

7. Submission to OSS

8. External Audit

9. Open-Closing CAPA for external Audit

10. Issuance of CPAKB certificate

Through experience, dedication, and commitment, we are ready to assist in jointly managing and collaborating to strengthen the Healthcare Equipment industry and drive economic growth in Indonesia.