Medical Device Post-Market Surveillance in Southeast Asia
Manufacturers and their locally appointed dealers (aka economic operators) are required to carry out Post-Market Surveillance (PMS) of their medical devices in the ASEAN market to ensure the quality and evaluate the safety, performance, and effectiveness of medical devices. This means manufacturers and appointed dealers shall actively monitor those medical devices placed on the market in order to protect users and the final consumer (patient) of the medical device.
Medical Device Post-Market Surveillance in Southeast Asia
Indonesia, Malaysia, Vietnam, Thailand, Philippines, Singapore , Cambodia, and are all signatories to the ASEAN Medical Device Directive (AMDD), which was created to harmonise medical device legislation throughout Southeast Asia. Article 12 of the AMDD calls for member states (10 countries in total) to take all necessary steps to appropriately record and evaluate information regarding incidents involving a medical device placed on the market in their respective country, such as malfunction, deterioration, or inadequacy which may lead to or may have led to the death or serious deterioration of the health of a patient or user. This includes post-market surveillance activities to monitor the ongoing safety and effectiveness of the devices.
To do this member countries are required to set up a PMAS (Post Marketing Alert System) which should cover at least:
To do this member countries are required to set up a PMAS (Post Marketing Alert System) which should cover at least:
- Importation and/or distribution records
- Complaint records
- Adverse Events (AE) reporting criteria and reporting format
- Field Safety Corrective Action (FCSA) reporting format.
Indonesia
Indonesia
- IVDs regulated by Ministry of Health as medical devices
- 4 risk classes (A-D) aligned with ASEAN MDD
- All IVDs require registration; some additional requirements for HIV and COVID tests
- MoH total review timeline: 45-80 working days based on risk class
Malaysia
Malaysia
- IVDs regulated by Ministry of Health as medical devices
- 4 risk classes (A-D) aligned with ASEAN MDD
- All IVDs require registration; some additional requirements for HIV and COVID tests
- MoH total review timeline: 45-80 working days based on risk class
Vietnam
Vietnam
- IVDs regulated by Ministry of Health as medical devices
- 4 risk classes (A-D) aligned with ASEAN MDD
- All IVDs require registration; some additional requirements for HIV and COVID tests
- MoH total review timeline: 45-80 working days based on risk class
Thailand
Thailand
- IVDs regulated by Ministry of Health as medical devices
- 4 risk classes (A-D) aligned with ASEAN MDD
- All IVDs require registration; some additional requirements for HIV and COVID tests
- MoH total review timeline: 45-80 working days based on risk class
Philippines
Philippines
- IVDs regulated by Ministry of Health as medical devices
- 4 risk classes (A-D) aligned with ASEAN MDD
- All IVDs require registration; some additional requirements for HIV and COVID tests
- MoH total review timeline: 45-80 working days based on risk class
Singapore
Singapore
- IVDs regulated by Ministry of Health as medical devices
- 4 risk classes (A-D) aligned with ASEAN MDD
- All IVDs require registration; some additional requirements for HIV and COVID tests
- MoH total review timeline: 45-80 working days based on risk class
Cambodia
Cambodia
- IVDs regulated by Ministry of Health as medical devices
- 4 risk classes (A-D) aligned with ASEAN MDD
- All IVDs require registration; some additional requirements for HIV and COVID tests
- MoH total review timeline: 45-80 working days based on risk class
How Andaman Medical can help with your medical device post-market surveillance
With eight local offices throughout Southeast Asia, Andaman Medical provides support for post-market surveillance activities including adverse events and FSCA mandatory reporting. Our local, in-house staff liaise with the local medical device authorities to help you maintain compliance once your medical device is placed on the market.
Medical device post-market surveillance in Southeast Asian countries in the AMDD are predominantly reactive reporting as opposed to proactive customer surveys and Post Market Clinical Follow-up (PMCF) studies.
As part of good business practice as well as regulatory compliance elsewhere in the world, all manufacturers and their dealers shall develop, implement and maintain systematic procedures to proactively collect and review data gained from medical devices placed on the market in order to identify needs for Corrective and Preventive Actions (CAPA).
Medical device post-market surveillance in Southeast Asian countries in the AMDD are predominantly reactive reporting as opposed to proactive customer surveys and Post Market Clinical Follow-up (PMCF) studies.
As part of good business practice as well as regulatory compliance elsewhere in the world, all manufacturers and their dealers shall develop, implement and maintain systematic procedures to proactively collect and review data gained from medical devices placed on the market in order to identify needs for Corrective and Preventive Actions (CAPA).
Our services include
Reporting
Reporting
Support for your mandatory reporting of Adverse Events and Field Safety Corrective Actions
Compliance Assurance
Compliance Assurance
Identify Southeast Asian requirements in medical device directives, standards, and guidance documents to ensure effective implementation of a post-market surveillance system
Data Evaluation
Data Evaluation
Evaluate your PMS data to ensure that existing processes and outputs are fully compliant
Regulatory Monitoring
Regulatory Monitoring
Monitor and report on any regulatory changes to ensure ongoing compliance
Support for your mandatory reporting of Adverse Events and Field Safety Corrective Actions
Identify Southeast Asian requirements in medical device directives, standards, and guidance documents to ensure effective implementation of a post-market surveillance system
Evaluate your PMS data to ensure that existing processes and outputs are fully compliant
Monitor and report on any regulatory changes to ensure ongoing compliance
Why Choose Andaman Medical?
