Faster Market Entry
Registration helps you enter the market quickly, avoiding delays and capturing opportunities faster.
Regulatory Recognition and Trust
Thai FDA approval boosts your product’s credibility and builds trust among healthcare providers and patients.
Access to a Growing Market
Registering your devices opens doors to Thailand’s expanding healthcare market with rising demand for advanced medical technologies.
Improved Patient Access and Outcomes
By registering your devices, you help make advanced medical technologies accessible to healthcare providers and patients, contributing to improved diagnosis, treatment, and overall healthcare outcomes in Indonesia.
Faster Market Entry and Expansion
Proper registration streamlines the process of bringing your products to market and facilitates quicker approval for new or updated versions of your devices, supporting faster scaling and adaptation to market needs.
Reduced Risk of Legal Penalties
Registering medical devices helps avoid legal issues, fines, and product recalls that could arise from selling unregistered or non-compliant products. It ensures that your business operations align with Indonesian laws and regulations.
Enhanced Market Credibility
Registered devices gain credibility and trust among healthcare providers and consumers. Regulatory approval signals that your products have met stringent local requirements, enhancing your brand’s reputation and competitive positioning in the market.
Regulatory Compliance
Compliance with Indonesia’s Ministry of Health regulations ensures that your products meet local safety, quality, and performance standards, which is essential for legal distribution and maintaining a positive market reputation.
Access to a Growing Market
Indonesia is Southeast Asia’s largest economy with a rapidly expanding healthcare sector, driven by a growing middle class and increased government healthcare spending. Registering your medical devices allows access to this lucrative market, offering significant growth opportunities for manufacturers.
Indonesia: Update on the List of Overseas Testing Centres for Certification Purposes of Telecommunication Devices and Equipment
Last April 25, 2024, the Indonesia Ministry of Communication updated the list of the laboratories/testing centers indicated in Decree No. 109 of 2024. This decree refers to the Determination of an Overseas Testing Centre for Certification Purposes of Telecommunication Devices and/or Equipment issued by the Director General of Resources Management and Equipment of Posts and
Indonesia: GDPMD Certificate as Mandatory Requirement for e-Catalogue Listing
The General Director of Pharmacy and Medical Devices signed a circular letter No. HK.02.02/E/1753/2024 on 09 September 2024, regarding the implementation of the Good Distribution Practice of Medical Device (GDPMD) Certificate as a mandatory requirement for listing in the e-Catalogue system. The circular letter highlights the following information: 1. Every medical device distributor is required
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Indonesia: New Decree concerning the Technical Standards of Short-Range Devices
The Minister of Communications and Informatics signed a New Decree Number 260 of 2024 concerning the Technical Standards of Short-Range Devices (SRD) on 13 May 2024. The regulated SRDs are as follows: 1. Bluetooth IEEE 802.15.12. Near Fields Communications (NFC)3. Radio frequency Identification (RFID)4. Ultra-wide bands (UWB)5. Low-Rate Wireless Personal Area Network IEEE 802.15.46. Cordless
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Andaman Medical: A Partner in Global Diagnostics Company’s Expansion into Malaysia
Fibronostics Fibronostics is a global diagnostics company shaping the future of non-invasive diagnostics. The company provides advanced solutions for the screening, identification, and monitoring of major metabolic diseases, which impact large patient populations globally. Fibronostics is a global company founded in Singapore, with labs and operations in the US, focusing on delivering innovative diagnostic tools
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Enhanced Market Credibility
Having a reputable LAR enhances the credibility of your brand in the Indonesian market, reassuring healthcare providers and patients that your devices are backed by local expertise and support, which can lead to increased trust and market acceptance.
Legal Accountability and Representation
The LAR assumes legal responsibility for the device within Indonesia, handling product recalls, safety alerts, and regulatory audits. This reduces the manufacturer’s legal risks and ensures local accountability.
Efficient Communication with Authorities
As a local point of contact, the LAR facilitates effective communication with Indonesian regulatory authorities, helping to resolve issues quickly and ensure timely responses to any regulatory inquiries or requirements.
Post-Market Surveillance and Compliance
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.
Local Market Insight
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.
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.
Regulatory Requirement Compliance
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.
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.
Thailand: Cancellation of Listing Approval Certificate due to Incorrect Risk Classification Category
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
Indonesia: Issuance of Regulation governing the Certification of Telecommunication Devices and/or Telecommunication Equipment
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
Vietnam: Notice of Domain Change for the Online Public Service System for Medical Device Management
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
Vietnam: Issuance of Draft Circular for Declaring the Prices of Medical Devices
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
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