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Indonesia: Announcement on International Tender Procurement by Ministry of Health

Leave a Comment / Indonesia, Regulatory updates / By andamanmedical

On October 10, 2024, Indonesia’s Ministry of Health (MoH) announced the opening of an International Tender Procurement for a project named Strengthening Indonesia’s Healthcare Referral Network (SIHREN). The official announcement is available on the e-Catalogue website in both Indonesian and English. You can access it here. Further details about the procurement process are available in […]

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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

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Additional support services

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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.

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Our authorized representative services include

Leave a Comment / Uncategorized / By andamanmedical

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 Read More »

Our registration services include

Leave a Comment / Uncategorized / By andamanmedical

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 Read More »

Regulatory Monitoring

Leave a Comment / Uncategorized / By andamanmedical

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 Read More »

Data Evaluation

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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 Read More »

Compliance Assurance

Leave a Comment / Uncategorized / By andamanmedical

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 Read More »

Reporting

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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.

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Vietnam: Survey and Gathering Feedback for the Draft of Medical Device Law

Leave a Comment / Regulatory updates, Vietnam / By andamanmedical

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

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Thailand: Guidelines for Attaching Medical Device Labels

Leave a Comment / Regulatory updates, Thailand / By andamanmedical

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

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Regulatory Monitoring

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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 Read More »

Complaint Handling

Leave a Comment / Uncategorized / By andamanmedical

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 Read More »

Business Presence

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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 Read More »

Authority Liaison

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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 Read More »

Labelling and Information

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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 Read More »

Compliance Assurance

Leave a Comment / Uncategorized / By andamanmedical

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 Read More »

Regulatory Representation

Leave a Comment / Uncategorized / By andamanmedical

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 Read More »

Ongoing Monitoring

Leave a Comment / Uncategorized / By andamanmedical

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 Read More »

Market Access and Competitiveness

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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.

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Quality Improvement

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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.

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Regulatory Compliance

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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.

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Ensuring Patient Safety

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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.

Ensuring Patient Safety Read More »