Building Trust with Healthcare Providers
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.
Maintaining Market Authorization
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.
Improvement of Product Quality
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.
Early Detection of Issues
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.
Regulatory Compliance
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.
Risk Management and Mitigation
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.
Building Trust with Healthcare Providers
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.
Maintaining Market Authorisation
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.
Improvement of Product Quality
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.
Early Detection of Issues
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.
Regulatory Compliance
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.
Thailand: Cancellation of the Announcement Related to the Diagnostic Test Kits and Reagents for SARS-CoV-2 B.E. 2567 (2024)
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
Thailand: Control Measures Adjustments for Diagnostic Test Kits and Reagents for COVID-19
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
Thailand: Guideline for the Registration of Diagnostic Test Kits and Reagents for SARS-CoV-2 (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
Risk Management and Mitigation
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.
Building Trust with Healthcare Providers
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.
Maintaining Market Authorization
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.
Improvement of Product Quality
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.
Early Detection of Issues
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.
Regulatory Compliance
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.
Local Presence
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.
Regulatory Compliance
The LAR ensures ongoing compliance with Vietnamese regulations by:
- Obtaining all necessary permits and licences.
- Meeting reporting and documentation requirements.
- Adhering to local laws and medical device regulations, including post-market surveillance and trade eligibility for devices.
Medical Device Registration
To handle the registration of medical devices, the LAR must:
- Create accounts on IMDA website for medical device and in-vitro diagnostic registration with the Ministry of Health.
- Apply for eligibility to trade Classes B, C, and D medical devices and obtain the Certificate of Medical Device Trading for those classes.
Business Registration and Licensing
The LAR is responsible for filing applications and managing business registrations with Vietnamese authorities. This includes:
- Obtaining necessary licences such as the Establishment License and Investment License.
- Setting up representative offices or branches as needed.
Liaison with Authorities
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.
Regulatory Requirement
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.
Local Representation for Product Issues
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.
Faster 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.
Up-to-Date Knowledge of Regulatory Changes
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.
Efficient Communication with Authorities
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.
