At the end of last March, the Ministry of Health issued guidance on procedures for the withdrawal and destruction of medical devices in Indonesia. The following is a detailed description of the types, criteria, roles and responsibilities, classifications, and procedures for withdrawing medical devices from circulation.
A. Medical Device Withdrawal Type
1. Mandatory Withdrawal
Based on the orders of the Ministry of Health, on the recommendation of the review of the results of the supervision found that there were Medical Devices that do not meet the standards or requirements.
2. Voluntary Withdrawal
Based on the initiation of the Medical Device Manufacturer, Medical Device Distributor as License Owner because they found out Medical Devices is produced and/or distributed does not meet the standards or requirements.
B. Medical Device Withdrawal Criteria
1. does not meet the requirements for safety, quality and benefits used;
2. have risks causing illness and injury when it’s produced, imported, and distributed;
3. in conformity with the provisions of the legislation when it’s produced, imported, and distributed;
4. has expired, for medical devices that have an expiration period;
5. illegal products (fake or do not have a distribution license);
6. cancellation of distribution permit/distribution permit is no longer valid; and/or
7. the labeling that is not in accordance with the approval, according to the analysis of the risk impact on health.
C. Roles and Responsibilities of Manufacturers and Distributors
The following are the roles and actions that need to be taken by Manufacturers, Importers, and Distributors who have the marketing license in the event of a withdrawal of their medical devices.
1. Make a notification regarding the withdrawal action of the Medical Device to the distribution chain;
2. Prepare a plan for withdrawing Medical Devices and follow the plan of withdrawal action from the distribution chain;
3. Report withdrawal plans and withdrawal results to Ministry of Health;
4. Consolidate to all Distributors and its customers all important information regarding Medical Devices to be withdrawn;
5. Monitoring and evaluating the effectiveness of withdrawal of Medical Devices ;
6. Report precautions to the Ministry of Health to avoid repeated events happened;
7. keeps records, data, accurate information and must be able shown at the time of inspection from the Ministry Health and Provincial / City / Regency Health Offices;
8. Destroying Medical Devices which is not safe.
D. Withdrawal Risk Classification and the duration of the withdrawal
Determination of the Security Period and Mandatory Withdrawal
High-risk medical device withdrawal is a withdrawal action that is carried out when the defective product is identified as potentially life-threatening and causes a serious health risk.
- Local security period / not allowed to be traded as soon as possible a maximum of 2 x 24 hours after withdrawal order received by the Ministry of Health.
- The period of time for withdrawing all medical devices from circulation, no later than 30 working days after the withdrawal order received by the Ministry of Health.
Medium risk medical device withdrawal is a withdrawal action that is carried out when the defective product causes disease or treatment errors but poses a medium risk (under high risk).
- Local security period / not allowed to be traded for a maximum of 5 x 24 hours after the withdrawal order received by the Ministry of Health.
- The period of time for withdrawing all medical devices from circulation, no later than 60 working days after the withdrawal order received by the Ministry of Health.
Low-risk medical device withdrawal is a withdrawal action that is carried out if a defective product is identified as not harmful to health, but it is necessary to withdraw it and the resulting risk is a low risk.
- Local security period / not allowed to be traded for a maximum of 10 x 24 hours after the warrant withdrawal is accepted.
- The period of time for withdrawing all medical devices from circulation, no later than 90 working days after the withdrawal warrant accepted by the Ministry of Health
E. Withdrawal Flowchart
The following is a flowchart of the withdrawal of medical devices in Indonesia:
Picture 1. Withdrawal process in Indonesia
*At stage 5: business actors are expected to report to the government. Reports in the form of:
a. report withdrawal results in the form of initial, periodic reports and final reports to the Ministry of Health and the Health Office;
b. report the results of the CAPA to the Ministry of Health;
c. report the results of destruction to the Ministry of Health and the Health Office.
With the issuance of this guidance, it is hoped that manufacturers, distributors, and supply chains involved in the circulation of medical devices can better know what actions need to be taken if they have medical devices that do not meet the criteria mentioned and conduct the withdrawal accordingly.