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UPDATED
MEDICAL DEVICE REGULATION
Presented by
ARIANTI ANAYA
Director of Medical Device Production and
Distribution Service Presented at
17th AHWP Meeting
TICC – Taipei,
MINISTRY OF HEALTH REPUBLIC OF INDONESIA 5 November 2012
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UPDATES OUTLINE
Background
Medical Device
Regulation in Indonesia
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INDONESIA:
Gateway to ASEAN
Taipei
(6hrs)
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UNIVERSAL COVERAGE
UNIVERSAL
COVERAGE
1 Jan 2014
Quality
Cost
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INDONESIA MEDICAL
DEVICE OVERVIEW
Population > 240.000.000
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LEGAL BASIS REGULATION
1. Act on health
3. MoH: Production
4. MoH: Distribution
PREMARKET
Ensure the PRODUCT CONTROL
safety, quality and eff
ectiveness of medical
POSTMARKET
devices REGULATION
CONTROL
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GOALS OF THE REGULATORY SYSTEM
IN INDONESIA
Obviously described
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Example for Attachment Accessories
or Type Registration License
Obviously described
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INDONESIA NASIONAL SINGLE WINDOW
MINISTRY OF HEALTH
1. Registration number
2. Name of Product
4. Type/ size
8. HS Code Number
10.Expired date
11.Country of origin
Directorate General of Pharmaceutical and Medical Device Service
Ministry of Health of Republic Indonesia
Obviously described
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Indonesia national single window
National Single Window (NSW) is a national system that will
integrate all entities which related to customs release and clearance
of cargoes with the aim of accelerating the settlement process of
import-export services and increased effectiveness and performance
of traffic handling import-export goods.
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e-REGISTRATION FOR
MEDICAL DEVICE
http://regalkes.depkes.go.id BACKGROUND
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FEATURES In
e-REGISTRATION
Distributors
Registration License
Number
Production
License
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DISTRIBUTION
Who can distribute
Medical Device in Company which have
Indonesia ? Distribution license issued by
MOH
DISTRIBUTOR
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THANK YOU / 谢谢
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