The Technical Responsible Person (PJT) plays a critical role in the management and distribution of medical devices in Indonesia. PJTs are responsible for ensuring that all distributed medical devices meet the required standards of quality, safety, and efficacy, as per applicable regulations.
Roles and Responsibilities of Technical Responsible Person
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- Regulatory Compliance Assurance:
The Technical Responsible Person ensures that all distributed medical devices have undergone testing and registration as mandated by the Ministry of Health and BPOM (Indonesian National Agency of Drug and Food Control). This includes compliance with the Good Distribution Practices for Medical Devices (CDAKB). - Risk Management:
PJTs identify, evaluate, and manage potential risks arising from the use of medical devices. This involves developing mitigation plans to address potential issues. - Post-Market Surveillance:
After products are distributed, the Technical Responsible Person monitors their performance in the market and addresses any safety or quality concerns reported by users. - Documentation and Reporting:
PJTs maintain records of all processes related to the production and distribution of medical devices and report distribution activities to the relevant authorities.
Technical Responsible Person Requirements for Distributors or Branches of Medical Device Distributors
1. Competency and Qualifications:
The Technical Responsible Person must be competent, authorized, and responsible for ensuring that the distribution system operates effectively to guarantee the safety, quality, and efficacy of distributed medical devices. Minimum educational qualifications are as follows:
| Medical Device Group | Educational Requirements |
|---|---|
| Electromedical Devices with Radiation | D3/S1 Pharmacy/Pharmacist D3/D4 Electromedical Engineering S1 Electrical Engineering D3/D4 Radiodiagnostic & Radiotherapy Engineering S1 Biomedical Engineering S1 Medical Physics |
| Electromedical Devices without Radiation | D3/S1 Pharmacy/Pharmacist D3/D4 Electromedical Engineering S1 Electrical Engineering D3/D4 Radiodiagnostic & Radiotherapy Engineering S1 Biomedical Engineering D3/S1 Informatics Engineering (for medical device software) D3 Optician Refraction (for ophthalmic devices) D3 Dental Engineering (for dental devices) |
| Non-Electromedical Sterile Devices | D3/S1 Pharmacy/Pharmacist D3/D4 Pharmaceutical Analyst D3 Optician Refraction (for ophthalmic devices) D3/S1 Medical Laboratory Technology D3 Orthotic Prosthetic (for orthopedic devices) S1 Chemistry S1 Chemical Engineering S1 Biomedical Engineering D3 Dental Engineering (for dental devices) |
| Non-Electromedical Non-Sterile Devices | D3/S1 Pharmacy/Pharmacist D3/D4 Pharmaceutical Analyst D3 Optician Refraction (for ophthalmic devices) D3 Orthotic Prosthetic (for orthopedic devices) D3 Dental Engineering (for dental devices) S1 Chemistry S1 Chemical Engineering S1 Biomedical Engineering |
| In Vitro Diagnostic Devices | D3/S1 Pharmacy/Pharmacist D3/D4 Electromedical Engineering (for instruments) D3/S1 Medical Laboratory Technology S1 Chemistry S1 Chemical Engineering S1 Biomedical Engineering D3 Chemical Analyst S1 Biology |
2. For Distributors Handling 4 or 5 Medical Device Groups, the Technical Responsible Person must, therefore, hold at least an S1 degree.
3. Conflict of Interest:
The Technical Responsible Person is, in fact, prohibited from simultaneously holding positions as a director or commissioner. Moreover, if the company operates additional production or distribution facilities, each facility must have a separate PJT.
4. CDAKB Training Certification:
The Technical Responsible Person must complete Good Distribution Practices for Medical Devices (CDAKB) training, as evidenced by a CDAKB training certificate.
5. Full-Time Availability:
The Technical Responsible Person must work full-time. If temporarily unavailable (e.g., due to sick leave or maternity leave), the distributor must appoint a temporary Technical Responsible Person with the required educational background for a maximum period of six months.
Technical Responsible Person for Multiple Warehouses
If a distributor or branch distributor operates multiple warehouse locations, each location must have a warehouse supervisor with educational qualifications that meet the Technical Responsible Person requirements.
This ensures compliance and the smooth operation of the medical device distribution system in Indonesia.
Sources:
Regulation of the Minister of Health of the Republic of Indonesia Number 14 of 2021
