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Recommendation for Medical Device Technical Responsible Person and/or Mechanical Engineer (PJT/Technician)
The Technical Responsible Person (PJT) is the individual in charge of technical matters related to product distribution. When a company applies for medical device-related certification, it is required to have a technical responsible person and/or a mechanical engineer (for example, if electronic medical devices are involved).
Basic Informations

Basic Information*

1.      The Technical Responsible Person (PJT) is the individual in charge of technical matters related to product distribution. When a company applies for medical device-related certification, it is required to have a technical responsible person and/or a mechanical engineer (for example, if electronic medical devices are involved).

2.      Qualifications of the Technical Responsible Person and Mechanical Engineer:

Technical Responsible Person

Mechanical Engineer

Indonesian nationality

Indonesian nationality

Pharmacy degree certificate from a local Indonesian university

Degree certificate in Mechanical Engineering / Biomedical Electronics from a local Indonesian university

3.      Responsibilities:

a.      Technical Responsible Person (PJT):

·       Responsible for recording information on daily procurement, receipt, storage, and distribution of products in accordance with current regulations

·       Maintain product quality and safety

·       Handle administrative matters with relevant authorities

·       Manage audits conducted by the Ministry of Health

·       Prepare and submit product management reports

b.      Mechanical Engineer:

·       Responsible for the daily maintenance of medical device equipment

4.      The following medical device certifications require a Technical Responsible Person (PJT) and/or a Mechanical Engineer:

a.      IDAK Certification

b.      CDAKB Certification

c.      CPAKB Certification

5.      The following are the required specialized personnel for various types of medical device equipment:

 

Radiation Electronics

                  Non-Radiation Electronics

Sterile Non-Electronics

Non-Sterile Non-Electronics

In Vitro Diagnostics (IVD)

Technical Responsible Person (PJT)

V

V

V

V

V

Mechanical Engineer (Technician)

V

V

–

–

V (for instruments)

Radiation Protection Engineer (PPR)

V

–

–

–

–

6.      This service is valid for one year and must be renewed upon expiration.

Processing Time & Required Documents

Processing Time : 5 Working Days

Required Documents :

1.      Identity Card (ID)

2.      Graduation Certificate

3.      Personal Tax Identification Card

4.      Proof of Residence (if the PJT’s ID is issued outside the Jabodetabek area)

5.      Phone Number

6.      Email Address

7.      Electronic Signature

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