The LAR is responsible for post-market activities, including monitoring device performance, handling adverse event reporting, and ensuring ongoing compliance with local regulations, which is crucial for maintaining market authorization.
An LAR provides valuable insights into the Indonesian market, including regulatory changes, local standards, and best practices. This knowledge helps manufacturers adapt their products and strategies to better fit market demands.
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 foreign manufacturer can set up a legal subsidiary entity in Indonesia with full investment. Alternatively, appointing a Local Authorised Representative (LAR) is also an option for registering and marketing medical devices. The LAR acts as a liaison with the Ministry of Health, ensuring that all regulatory requirements are met efficiently.
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.
The Thai Food and Drug Administration issued an infographic regarding an occurrence that may result in the cancellation of the listing approval certificate. According to the Ministry of Public Health Notification, manufacturers and importers must submit a listing application for a device, an apparatus, a machine, an object inserted into the body, a solution used
The Minister of Communications and Informatics in Indonesia issued regulation No. 3 of 2024 concerning Telecommunication Device and/or Telecommunication Equipment Certification. This regulation consists of 62 articles that describe and regulate the requirements applied in the certification process of telecommunication devices and/or equipment. As stated, any telecommunication device and/or equipment manufactured, assembled, or imported for
The Department of Infrastructure and Medical Equipment announced the change of the domain name for the Online Public Service Portal on Medical Equipment Management in Vietnam as below: Old Domain: https://dmec.moh.gov.vn New Domain: https://imda.moh.gov.vn Implementation Timeline: From September 1, 2024, until December 31, 2024, both the old and new domains will be maintained simultaneously for
The Vietnam Ministry of Health issued a draft Circular on Regulations for Declaring the Prices of Medical Devices, which will cover the following aspects: The economic and technical characteristics of medical devices for price declaration; and The receiving Authority and entities responsible for declaring the prices of medical devices. The list of medical devices for
Vietnam: Issuance of Draft Circular for Declaring the Prices of Medical Devices Read More »
Decree No. 109 of the Year 2024 concerning the Determination of an Overseas Testing Centre for Certification Purposes of Telecommunication Devices and/or Equipment was issued by the Director General of Resources Management and Equipment of Posts and Informatics under the Ministry of Communications and Informatics. According to the regulation, the test Report from Overseas could
The Health Sciences Authority (HSA) Singapore has initiated a new optional regulatory pathway – Change Management Program (CMP), specifically for SaMD that is incorporated into HSA’s Premarket Product Registration and Change Notification (CN) processes. CMP’s eligibility requires mandatory and valid conformance to latest standards of ISO 13485 and IEC 62304 throughout SaMD total product lifecycle
Singapore: Consultation on draft of Guidance on Change Management Program (CMP) for SaMD Read More »
Medical Device Control Division would like to inform entrepreneurs to follow the guidelines for displaying warnings, prohibitions, and precautions in advertising medical devices in accordance with the Thai FDA announcement. The criteria, methods and conditions for issuing licenses and medical device advertising license 2021 (B.E. 2564), with details according to the manual for requesting permission
On August 27, 2024, Thailand FDA published an infographic about Medical Device Advertisement on their official Facebook page. Here are some examples of “text, images, or advertising” that are “not allowed” in advertising medical devices: Using words or statements about the benefits, quality, quantity, standards, ingredients, or origin of medical devices in an exaggerated manner,
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