Post-market surveillance (PMS) is a mandatory requirement by the Ministry of Health to ensure continued safety, effectiveness, and quality of medical devices in the market. Regular monitoring helps maintain compliance with local regulations and avoids penalties.
PMS helps manufacturers identify and address risks associated with their devices, enabling timely corrective actions and reducing the likelihood of costly recalls, legal issues, and damage to brand reputation.
PMS data helps build confidence among healthcare professionals by providing evidence of ongoing device performance and safety. This trust can lead to increased adoption and recommendation of your products.
Effective post-market surveillance is critical for maintaining your device’s market authorization. Ongoing compliance with surveillance requirements demonstrates your commitment to product safety and helps avoid the risk of losing regulatory approval.
Continuous monitoring provides valuable feedback on device performance in real-world settings. This information can be used to enhance product design, manufacturing processes, and overall quality, leading to better patient outcomes.
PMS allows for the early identification of potential safety concerns, performance issues, or adverse events related to your device. This proactive approach helps prevent widespread problems and protects patients from harm.
Post-market surveillance (PMS) is a mandatory requirement by the Ministry of Health to ensure continued safety, effectiveness, and quality of medical devices in the market. Regular monitoring helps maintain compliance with local regulations and avoids penalties.
To ensure that the control measure of medical devices is appropriate to the current situation and in line with the development of medical technology, it is expedient to cancel the announcements from the Ministry of Public Health related to medical devices for the detection of SARS-CoV-2 (COVID-19). Therefore, the Minister of Public Health, upon recommendation
The Thai Food and Drug Administration Office (TFDA) has adjusted control measures for the diagnostic test kits and related reagents for SARS-CoV-2 (COVID-19) detection to align with the risk levels of medical devices. The previous requirements for technology assessment and related standards for manufacturers or importers of COVID-19 test kits have been canceled. Nowadays COVID-19
The Thai Food and Drug Administration (FDA) issued an infographic regarding the guideline for registration of notified medical device for diagnostic test kits and reagents for SARS-CoV-2 (COVID-19). The infographic (in Thai) can be accessed here. The main idea of this infographic is referred from the Ministry of Public Health Notification RE: Cancellation of Ministry
PMS helps manufacturers identify and address risks associated with their devices, enabling timely corrective actions and reducing the likelihood of costly recalls, legal issues, and damage to brand reputation.
PMS data helps build confidence among healthcare professionals by providing evidence of ongoing device performance and safety. This trust can lead to increased adoption and recommendation of your products.
Effective post-market surveillance is critical for maintaining your device’s market authorization. Ongoing compliance with surveillance requirements demonstrates your commitment to product safety and helps avoid the risk of losing regulatory approval.
Continuous monitoring provides valuable feedback on device performance in real-world settings. This information can be used to enhance product design, manufacturing processes, and overall quality, leading to better patient outcomes.
PMS allows for the early identification of potential safety concerns, performance issues, or adverse events related to your device. This proactive approach helps prevent widespread problems and protects patients from harm.
Post-market surveillance (PMS) is a mandatory requirement by the Ministry of Health to ensure continued safety, effectiveness, and quality of medical devices in the market. Regular monitoring helps maintain compliance with local regulations and avoids penalties.
Appointing a LAR gives foreign companies a local presence and in-depth knowledge of the Vietnamese regulatory landscape without the need to set up their own subsidiary. This provides practical business advantages and simplifies operations.
The LAR ensures ongoing compliance with Vietnamese regulations by:
To handle the registration of medical devices, the LAR must:
The LAR is responsible for filing applications and managing business registrations with Vietnamese authorities. This includes:
The LAR acts as the primary point of contact between the foreign company and Vietnamese regulatory bodies, including the Ministry of Health (MOH). They handle all official communications, submissions, and negotiations on behalf of the foreign entity.
Foreign companies without a registered office in Vietnam are legally required to appoint a Local Authorised Representative (LAR). This is mandated by Vietnamese law to ensure compliance and the ability to conduct business activities within the country.
A LAR is responsible for handling post-market surveillance, adverse event reporting, and product recalls, providing a local point of contact for regulatory authorities, which is crucial for ongoing market access.
With the local knowledge and established relationships with regulators, a LAR can expedite the approval process, allowing faster entry into the Thai market and enabling companies to start selling their medical devices sooner.
LARs keep companies informed about the latest regulatory updates and policy changes in Thailand, ensuring ongoing compliance and helping to adapt strategies quickly when needed.
LARs act as a direct communication link between the company and Thai regulatory bodies, effectively addressing any questions, requests for additional information, or changes in requirements.
A LAR ensures that all requirements set by Thailand’s Food and Drug Administration (Thai FDA) are met, helping companies stay compliant with current regulations and avoid penalties or product recalls.
A LAR has the local expertise and understanding of regulatory procedures, helping to navigate complex documentation and submission requirements. This streamlines the registration process, reducing the risk of delays and rejections.
A LAR is responsible for handling post-market surveillance, adverse event reporting, and product recalls, providing a local point of contact for regulatory authorities, which is crucial for ongoing market access.
With the local knowledge and established relationships with regulators, a LAR can expedite the approval process, allowing faster entry into Singapore market and enabling companies to start selling their medical devices sooner.
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