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Andaman Medical at CMEF Shenzhen Watch the full video
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Regulatory affairs and market access for medical devices & IVDs across Southeast Asia since 2013 From registration to ongoing authorized representation for post-market surveillance and compliance; from importation including customs clearance to distribution of your products, we promise to get your medical device to your customer. We focus exclusively on medical devices and IVDs across
Additional support services
- The Department of Medical Equipment and Construction (DMEC) conducts post-market inspections to ensure the quality of imported and circulated devices.
- PMS activities include inspections, sampling, testing, and adverse event reporting.
- Manufacturers and distributors must report any adverse events or product defects to the authorities.
Our authorized representative services include
- The Department of Medical Equipment and Construction (DMEC) conducts post-market inspections to ensure the quality of imported and circulated devices.
- PMS activities include inspections, sampling, testing, and adverse event reporting.
- Manufacturers and distributors must report any adverse events or product defects to the authorities.
Our registration services include
- The Department of Medical Equipment and Construction (DMEC) conducts post-market inspections to ensure the quality of imported and circulated devices.
- PMS activities include inspections, sampling, testing, and adverse event reporting.
- Manufacturers and distributors must report any adverse events or product defects to the authorities.
Regulatory Monitoring
- The Department of Medical Equipment and Construction (DMEC) conducts post-market inspections to ensure the quality of imported and circulated devices.
- PMS activities include inspections, sampling, testing, and adverse event reporting.
- Manufacturers and distributors must report any adverse events or product defects to the authorities.
Data Evaluation
- The Department of Medical Equipment and Construction (DMEC) conducts post-market inspections to ensure the quality of imported and circulated devices.
- PMS activities include inspections, sampling, testing, and adverse event reporting.
- Manufacturers and distributors must report any adverse events or product defects to the authorities.
Compliance Assurance
- The Department of Medical Equipment and Construction (DMEC) conducts post-market inspections to ensure the quality of imported and circulated devices.
- PMS activities include inspections, sampling, testing, and adverse event reporting.
- Manufacturers and distributors must report any adverse events or product defects to the authorities.
Reporting
- The Department of Medical Equipment and Construction (DMEC) conducts post-market inspections to ensure the quality of imported and circulated devices.
- PMS activities include inspections, sampling, testing, and adverse event reporting.
- Manufacturers and distributors must report any adverse events or product defects to the authorities.
Vietnam: Survey and Gathering Feedback for the Draft of Medical Device Law
Regulatory updates, Vietnam On October 4, 2024, the Ministry of Health (MoH) of Vietnam issued three notices—Notice No. 6065/BYT-HTTB to the Department of Health (DoH), Notice No. 6066/BYT-HTTB to medical device manufacturers, and Notice No. 6067/BYT-HTTB to traders, exporters, and importers—calling for a survey of the current situation and gathering feedback on the draft of
Vietnam: Survey and Gathering Feedback for the Draft of Medical Device Law Read More »
Thailand: Guidelines for Attaching Medical Device Labels
Regulatory updates, Thailand On October 11, 2024, the Thai Food and Drug Administration (FDA) published new guidelines on labeling requirements for medical devices. These guidelines provide clarity on how labels should be attached to medical devices intended for both home use and professional use. The key points of the guidelines are as follows: 1. Labeling
Thailand: Guidelines for Attaching Medical Device Labels Read More »
Regulatory Monitoring
- The Department of Medical Equipment and Construction (DMEC) conducts post-market inspections to ensure the quality of imported and circulated devices.
- PMS activities include inspections, sampling, testing, and adverse event reporting.
- Manufacturers and distributors must report any adverse events or product defects to the authorities.
Complaint Handling
- The Department of Medical Equipment and Construction (DMEC) conducts post-market inspections to ensure the quality of imported and circulated devices.
- PMS activities include inspections, sampling, testing, and adverse event reporting.
- Manufacturers and distributors must report any adverse events or product defects to the authorities.
Business Presence
- The Department of Medical Equipment and Construction (DMEC) conducts post-market inspections to ensure the quality of imported and circulated devices.
- PMS activities include inspections, sampling, testing, and adverse event reporting.
- Manufacturers and distributors must report any adverse events or product defects to the authorities.
Authority Liaison
- The Department of Medical Equipment and Construction (DMEC) conducts post-market inspections to ensure the quality of imported and circulated devices.
- PMS activities include inspections, sampling, testing, and adverse event reporting.
- Manufacturers and distributors must report any adverse events or product defects to the authorities.
Labelling and Information
- The Department of Medical Equipment and Construction (DMEC) conducts post-market inspections to ensure the quality of imported and circulated devices.
- PMS activities include inspections, sampling, testing, and adverse event reporting.
- Manufacturers and distributors must report any adverse events or product defects to the authorities.
Compliance Assurance
- The Department of Medical Equipment and Construction (DMEC) conducts post-market inspections to ensure the quality of imported and circulated devices.
- PMS activities include inspections, sampling, testing, and adverse event reporting.
- Manufacturers and distributors must report any adverse events or product defects to the authorities.
Regulatory Representation
- The Department of Medical Equipment and Construction (DMEC) conducts post-market inspections to ensure the quality of imported and circulated devices.
- PMS activities include inspections, sampling, testing, and adverse event reporting.
- Manufacturers and distributors must report any adverse events or product defects to the authorities.
Ongoing Monitoring
- The Department of Medical Equipment and Construction (DMEC) conducts post-market inspections to ensure the quality of imported and circulated devices.
- PMS activities include inspections, sampling, testing, and adverse event reporting.
- Manufacturers and distributors must report any adverse events or product defects to the authorities.
Market Access and Competitiveness
- A robust PMS system ensures compliance with evolving regulatory requirements.
- Proactive monitoring and resolving of issues give manufacturers a competitive advantage.
- Positive safety and performance data build trust with healthcare providers and patients.
Quality Improvement
- PMS data provides valuable insights into device performance, helping manufacturers identify areas for improvement.
- Analysing PMS data supports informed decisions on product enhancements and updates.
- Addressing issues found through PMS can lead to better product quality and reliability.
Regulatory Compliance
- Medical device PMS in Vietnam is a regulatory requirement, as outlined in Decree No. 98/2021/ND-CP on Medical Device Management.
- Licence holders must maintain detailed device history records and follow mandatory reporting procedures.
- Non-compliance can result in import delays or loss of market access.
Ensuring Patient Safety
- PMS enables manufacturers and regulatory authorities to detect safety issues early by monitoring real-world device performance.
- It helps identify and address potential adverse events that could impact users’ health.
- Timely corrective actions, such as suspending distribution or recalling defective devices, can be taken to protect patients.
Sustained Market Access
Regular surveillance helps maintain compliance, ensuring your devices continue to be sold legally in Thailand.
Quick Response to Issues
PMS enables rapid response to product defects or failures, minimising the impact on patients and your market position.
Improved Product Performance
Feedback from PMS can be used to improve device design and functionality, enhancing overall product quality.
Market Credibility
Ongoing surveillance demonstrates your commitment to product safety and quality, enhancing your reputation among healthcare providers and patients.
Risk Management
PMS allows you to detect and mitigate risks associated with device use, reducing the likelihood of adverse events.
Patient Safety
Monitoring product performance helps identify and address safety issues early, protecting patients from potential harm.
Regulatory Compliance
PMS ensures that your products meet ongoing regulatory requirements set by the Thai FDA, avoiding penalties or market withdrawal.
