1. MEDICAL DEVICES CONTROL SYSTEM IN INDONESIA
MINISTRY OF HEALTH OF RI
DECEMBER 2006

2. Basic Regulation
1. Law of the Republik Indonesia in 1992 regarding health
2. Government regulation no. 72 in 1998, regarding the safety of pharmacetical preparation and medical devices
3. Ministerial regulation of Health of RI no 1184/Menkes/Per/X/2004, regarding medical devices and household safety.

3. Medical Devices
Any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent and calibrator, software, material on other similar or related article :
a. intended by the manufacturer to be uses
alone or in combination, for human being
for one or more of the spesific purpose of.
- Diagnosis, prevention, monitoring,
treatment on alleviation of disease
- Diagnosis, monitoring, treatment, alleviation or
compensation for injury
- Investigation, replacement or modification of the
anatomy on of a physiological process

4. Medical devices…. continue
- Supporting or sustaining life
- Control of conception
- disinfection of medical devices
- providing information for medical
or diagnostic purpose by means
of in vitro examination of
specimens derived from the human body

5. Medical devices…. continue
And
b. which does not achieve its principal intended action in or on the human body. By pharmacological, imonological or metabolic means, but which may be assisted in its function by such means.

6. MEDICAL DEVICE CLASIFICATION
REGULATORY REQUIREMENT
III
II B
II A I
Device classes (risk based)

7. Scope of Medical Devices Control System
Production
Conformity assesment (registration)
Distribution
Market
User 1 5 3 4 2

8. Production Production certificate issues by MOH Base on : Medical Devices GMP (Ref ISO 13485)
Assessor :
- Regulator : center and province Health officer
We recognize what CAB done for production certificate

9. Distribution Distribution licence issued by MOH. Point to access :
Who distribute (letter of Appointment)
Infra structure
Documentation
Note :
Distributor should be a sole agent principal for certain product

10. Confirmity Assesment ( Regulation )
Applicant should have :
- Import : Distribution licence
- Local : Production licence
Submitted registration form

11. REGISTRATION PROCEDURE
Expert Team
Applicant
Administration
Check
Scientific
Evaluation
Final
Decision
yes
yes No
Registration
Number No

12. Matriks of registration requirement for medical devices base on medical devices clasification
Class I
Class II (A&B)
Class III
Form A : Administration data
Letter of authorization as a sole agent by principal
Certificate of production
Distribution licence
any administration doc. Such as :
Tax no
Location
Letter of authorization as a sole agent by principall
location

13. Registration Requirment ( continue )
Form
Class I
Class II (A&B)
Class III
Form B :
Post Market requirement
Procedure, record sys, complaint handling
Procedure, record sys, complaint handling adverse affect report and recall system
Procedure, record sys, complaint handling, adverse affect report and recall system

14. Form Class I Class II (A&B) Class III Form C : Product Information
Objective and instruction for use
Product information. Brochure/ leaflet
component /formula qualitative
labeling
Indication
control indication
warning
attention
product description
component /formula qualitative/ quantitative
- Potential adverse effect
- Raw material and packaging

15. Form Class I Class II (A&B) Class III Form D : Conformity Statement
- Statement about conformity to standard safety – requirement and quality system
Certificate or document about :
Quality and Safety requirement ( COA finish product, etc. )
Quality system
Product standard
Quality plan
production process
From E :
Distribution status
C F S
Summary of the problem has been recorded

16. Form Class I Class II (A&B) Class III Form F : Product Safety data
none
Summary of safety and effectiveness study (II B)
Sterilization method
summary of safety and efficacy study
References
Risk assessment
Risk analysis
evaluation
measurement
Summary of safety and efficacy study
Pre clinic test
clinical test
validation
summary of study
From G :
Clinical Data
Scientific references
result of clinical study

17. Post market surveylance
Monitoring
Sampling
PMS is carried out by
MOH (Province Health Officer)
Manufacturer in order to warranty of their product

18. Thank you ...