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.
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.
Regulatory Compliance
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.
Streamlined Registration Process
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.
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 Singapore 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 Singapore, 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 Singapore’s regulatory bodies, effectively addressing any questions, requests for additional information, or changes in requirements.
Regulatory Compliance
A LAR ensures that all requirements set by Singapore’s Ministry of Health are met, helping companies stay compliant with current regulations and avoid penalties or product recalls.
Streamlined Registration Process
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.
