on the Medical Devices' registration processes
on the Medical Devices’ registration processes
PT. Medquest Jaya Global
~ Growth Through Innovation and Technology ~
Head Office
Menara Salemba 6 th Fl, Zone 1
Jl.Salemba Raya Kav 5-5A, Jakarta Pusat 10440 - Indonesia
Telp. +62 21 39842961, Fax. +62 21 31937736
Web : www.medquest.co.id
Warehouse
Commercial Estate Bizpark 1 Pulo Gadung, Blok A12
Jl. Raya Bekasi Km.21, Jakarta Timur
PT MEDQUEST JAYA GLOBAL
• Established on 7 April 2004
• Founded by Nanik Gunawan and Susiana
• Currently have 122 employees
• • 4 business groups:
1.
Hospital and Pharma
2.
Blood Bank
3.
Life Sciences
4.
Special Projects
REGISTRATION PROCESS PATHWAY
CLASS
Upload the application form to online reg system, required documents
Evaluator will verify the product category for
/PNBP (7 WDs)
Verification Result
Payment Letter
Applicant pay the registration cost
(e-payment)
Upload the proof of payment
Applicant will be rejected if time limit exceeded
(10 Days)
Applicant Status will change into Admin Counter – File
Adminssion Pocess
REGISTRATION PROCESS PATHWAY
1 st Evaluation:
A.
Production Certificate of
Medical Devices and
Household Products
B.
Distributor License of
Medical Devices
C.
Marketing Authorization
Holder for Medical Devices and Household Products
• Class I : 45 WD
• Class II
• Class III
: 80 WD
: 100
WD
Upload the proof of payment
REJECTED
File
Adminssion
Pocess
1st
Evaluation
1st Additional
Required Documents
(30 Days)
2nd Evaluation
30 Days
APPROVAL
APPROVAL
2nd Additional
Required Documents
(30 Days)
3rd Evaluation
30 Days
APPROVAL
OUR EXPERIENCES
After > 10 years
And more than 600 applications submitted
NO REJECTED APPLICATION
(100% approved)
KEY SUCCESS FACTOR
• Comply the MoH’s procedure
• Bridging Evaluation For the products that have registered in 5 countries with reputable RA Authority (USA,
Canada, Australia, Japan, Europe)
• Submit a complete registration dossier
• • Make a clear and descriptive application
• For the innovative and high technology products:
– Give a clear and comprehensive explanation on Product
Description (in Bahasa)
– Consult it to the RA Authority, if needed
• Submit the required additional documents as soon as possible (before the time limit exceeded)
