Directorate of Medical Device and Household Control

MINISTRY OF HEALTH REPUBLIC OF INDONESIA

INDONESIAN REGULATION UPDATES POST MARKET REGULATORY SYSTEM FOR

MEDICAL DEVICES

INDONESIA MEDICAL DEVICE OVERVIEW

• Medical Devices Manufactures = 239

• Medical Devices Suppliers = 2.768

• Registered Medical Devices

Import = ± 36.700 items

Local = ± 4.250 items

• Primary Health Care : ± 8500

• Hospital : ± 1150

THE REGULATORY SYSTEM IN INDONESIA

• Both product risk and compliance risk can be managed by premarket activities and post market activities

Risk Based Approach

• Indonesia which is one of the ASEAN member economies will have the same vision to achieve the ASEAN Economy Society

ASEAN HARMONIZATION

• Indonesia as one of the World Nations, has the same standard quality as used in global harmonization regulation

International Standard

• One of the priorities of Indonesian Health reform policies is to strengthen the public services

Transparency and excellent service

LEGAL BASIS REGULATION

National Act of Health No. 36/2009

Gov. Regulation: No. 72/1998

Security of Health Products

MoH Decree No. 1190/2010 : Registration of MD

MoH Decree No 1191/2010 : Distribution License

INDONESIA Ministry of Health

MoH Decree No. 1189/2010 : Production Certification

MEDICAL DEVICE REGULATORY CONTROLS CURRENTLY LEGISLATED

FULLY IMPLEMENTED UNDER THE MEDICAL DEVICE LEGISLATION

1. Common Submission Dossier

Template (CSDT)

2. ISO 13485 for QMS

3. Good Distribution Practice

4. Post market Surveillance System

5. International Standard and

Indonesia National Standard for

ensuring the safety, quality and

effectiveness of medical device

PREMARKET & POST MARKET CONTROL

ASEAN

HARMONISATION

REGULATION

SYSTEM

INDONESIA has adopted

e-REGISTRATION FOR

MEDICAL DEVICE IN INDONESIA

• Wide area of Indonesia teritory

• Optimize public service

• Quick registration system and can be access anywhere

http://www.regalkes.depkes.go.id

e-Registration Online

BACKGROUND

PRODUCTS

LICENSE

PRODUCTION

CERTIFICATE

DISTRIBUTOR

LICENSE

Post Market Surveillance

To control the PMS, MOH have goverment Civil police Investigator

for medical devices who works together with Hospital/Healthcare

facilities, police, custom and Health province officer

PMS should supported by strict law enforcement

• A periodical activity to taking sample from market and then testing it to laboratory for compliance check SAMPLING

• A periodical activity to audit the production and distribution facilities compliance with Quality System standard MONITORING

• A program activity to audit Adverse event report VIGILLANCE

• A program to monitoring and evaluation of MD Product Advertising ADVERTISING

COMPREHENSIVE SAMPLING STEPS

1. PLANNING

Products selection

Locus of site

Time Scheduled

Official assignment

Stakeholder coordination

Supporting facility

2. SAMPLE TAKING

Labeling Check

Packaging Check

Sample size counting

Notification Letter and documents

3. SAMPLE MANAGEMENT

Codefication

Repacking/Wrapping

Storage retain sample

4. LABORATORY

TESTING

Documents

Confirmation of code and

testing

Result of testing

5. CERTIFICATE OF TEST RESULT

Certificate submission

Compilation and

tabulation

Certificate filing

6. ANALYSIS

Risk category

Follow up action

7. CAPA

Corrective action

Monitoring follow up

Entry e-inspeksi

Reporting

CONTROLS UNDER THE MEDICAL DEVICE

POST-MARKET SURVEILLANCE

1. ADVERSE EVENTS REPORTING

REPORTABLE ADVERSE EVENT ADOPTED FROM ASEAN

AGREEMENT (AMDD)

MANDATORY REPORTING UNDER THE VOLUNTARY

REGULATORY SYSTEM

REPORTED BY AUTHORIZED REPRESENTATIVE/REGISTRANT

AND OPERATOR ON HEALTHCARE INSTITUTION AND

PROFESSIONALS

BOTH LOCAL AND REGIONAL AE ARE REQUIRED TO BE

REPORTED

1ST PHASE VOLUNTARY & 2ND PHASE MANDATORY

CATEGORIZED ACCORDING SEVERITY OF HARM

CONDUCT TRENDING PROCEDURE AS MEDICAL DEVICE

TYPE/CATEGORY

CONTROLS UNDER THE MEDICAL DEVICE

POST-MARKET SURVEILLANCE

2. PRODUCT RECALLS

DEFENITION AS RESULTS OF BANNED OF

MARKETING APPROVAL FOR PRODUCT THAT

CAUSED SERIOUS INJURY AND LEAD TO PUBLIC

HEALTH THREAT AND PRODUCT THAT DOES NOT

MEET REQUIREMENT(S) AS DECLARED IN

REGISTRATION PROCESS

MANDATORY ORDER FROM THE REGULATORY

AUTHORITY

RESPONSIBLE FOR CONDUCTING RECALL DONE BY

IMPORTER AND WHOLESALER/DISTRIBUTOR

CATEGORIZED ACCORDING SEVERITY OF HARM AND RISK

FACTORS FOR HEALTHCARE PROFESSIONALS OR

CAREGIVERS

1. FIELD SAVETY CORRECTIVE ACTION (FSCA)

CONTROLS UNDER THE MEDICAL DEVICE

POST-MARKET SURVEILLANCE

3. FIELD SAVETY CORRECTIVE ACTION (FSCA)

NO SPESIFIC DEFINITION FOR FSCA, ADOPTED FROM AMDD

MANDATORY REPORTING UNDER THE VOLUNTARY REGULATORY

SYSTEM

RESPONSIBLE FOR REPORTING FSCA DONE BY IMPORTER AND

WHOLESALER/DISTRIBUTOR

RESPONSIBLE FOR CONDUCTING FSCA DONE BY LOCAL

MANUFACTURER, IMPORTER AND WHOLESALER/DISTRIBUTOR AND

RETAILER

CATEGORIZED ACCORDING SEVERITY OF HARM, LIKELIHOOD OF

RISK AND DISTRIBUTION OF NONCONFORMING DEVICES

AROUND 35 CASES ANNUALLY, NONE PRODUCT RECALL AND 16

CASES FSCA ACTION TAKEN

LESS THAN 10 OFFICER IN POST MARKET TEAM (AE=4, FSCA=3, E-

WATCH POST MARKET MONITORING SYSTEM=2)

Follow up Action

Based on test result of substandard, the Director of Post Market Control able to take some administrative action for correction

1. Product Surveillance Notice 2. Warning Letter (SP1 – SP2) 3. Product Recall 4. Recommendation of Product Banned .

Classification of test result determined as Substandard

RATE OF SUBSTANDARD:

Catagory 1 Very serious. Credibility of product owner/importer is in the threat caused by the unsafe product endanger public health and user, product banned able to seized

Catagory 2 Serious. Substandard product is still safe for public health and user, corrective action sooner and first priority for further sampling at the same fiscal year

Catagory 3 Minor, Substandard product is still safe for public health and user, priority for further sampling next year

Catagory Rate Event of Substandard

1 Very Serious

Endanger public health and user

Fake product

Fake Registration Number

Without marketing authorization

Fatal mistake of callibration

Expiry date passed

2 Serious Still safe for public health and user

Calibration of high volume syringe

Labeling without instruction for use

Expiry date just passed

Repetition of Minor

3 Minor No harm for public health and user

Expiry date almost passed

Excessive antibacterial claimed

INTEGRATION OF VIGILANCE REPORTING

ASPAK

E-WATCH

ASPAK is an application for facility and

device management in Hospital and

health facilities

Benefit of ASPAK is related to facility

development planning and utility

networking among health facilities

Data updated regularly and continue

Able to be accessed by MoH, Provincial

Health Office, Maintenance Centre,

Hospital and Health Centre

E-watch is an application for Adverse

Event reporting related to the use of

substandard device

Corrective Action and Preventive Action is

needed to avoid the recurrence of events

Early Detection System involve complain

handling from community and anticipate

with field safety corrective action

CONCLUSION

• Indonesia is highly concern in harmonizing medical devices in a

Global, Asia, and ASEAN level. With all the member economies,

Indonesia works together to achieve the benefit of harmonization

• Medical device regulatory controls currently legislated. Fully

implemented under the medical device legislation

• To control the PMS, MOH have goverment Civil police Investigator

for medical devices who works together with Hospital/Healthcare

facilities, police, custom and Health province officer

• Categorized of product recall according severity of harm and risk

factors for healthcare professionals or caregivers

• Integration of vigilance reporting lead to Early Detection System

involve complain handling from community and anticipate with field

safety corrective action

THANK YOU

TERIMA KASIH