Legal Protection
Proper registration provides legal protection for your product. It helps in defending against counterfeit products and ensures that your intellectual property rights are safeguarded.
September 2024
Brand Reputation
A registered medical device enhances your brand’s reputation. It shows that you prioritize regulatory compliance and patient safety, which can lead to increased trust and loyalty from healthcare professionals and patients.
Regulatory Compliance
Compliance with Cambodian regulations ensures that your medical device meets the safety, efficacy, and quality standards required by the Ministry of Health. This compliance not only avoids legal issues but also builds trust with healthcare providers and patients.
Market Access
Registering your medical device grants you legal access to the Cambodian market. Without proper registration, you cannot legally sell or distribute your products within the country.
Indonesia: New Draft of Minister of Health Regulation concerning Health Supplies
This new draft is a derivative of the Presidential Regulation No. 28 Year 2024 and contains 282 articles which regulates the health supplies. It defines that Health Supplies are all materials and equipment necessary for Health Efforts such as Pharmaceutical Preparations, Medical Devices, and other Health Supplies according to the needs. The scope of this
Indonesia: New Draft of Minister of Health Regulation concerning Health Supplies Read More »
Medical Tourism Hub
As a leading medical tourism destination, Malaysia sees a high demand for quality medical devices, attracting international patients seeking advanced diagnostic solutions.
Favourable Business Environment
Malaysia offers a business-friendly environment with incentives for foreign manufacturers. The country’s robust infrastructure, skilled workforce, and supportive government policies make it an attractive destination for medical device companies.
Regulatory Compliance
Malaysia’s regulatory framework, overseen by the Medical Device Authority (MDA) under the Ministry of Health, ensures that only safe and effective devices enter the market. Compliance with these stringent regulations enhances the credibility and acceptance of your IVD device both locally and internationally.
Growing Market
Malaysia’s medical device market is expanding rapidly, driven by an increasing demand for advanced healthcare solutions. As a key player in Southeast Asia, Malaysia provides access to a large and diverse patient population.
Regulatory Compliance
Registering your IVD and non-IVD medical device guarantees compliance with Vietnam’s regulatory requirements, enabling legal marketing and distribution. It demonstrates your commitment to quality and safety, strengthening your brand’s reputation.
Partnering Opportunities
Vietnam’s expanding healthcare sector attracts local and international investors. By registering your IVD and non-IVD medical device, you unlock opportunities for strategic partnerships with local distributors, hospitals, and clinics, enhancing your market presence and business growth.
Market Access and Distribution
Proper medical device registration in Vietnam ensures smoother market access and distribution across Vietnam, helping you avoid legal issues, delays, and supply chain disruptions. This allows your products to reach healthcare providers efficiently.
Market Credibility
Registration enhances your company’s credibility in the market,
making your products more attractive to distributors and partners.
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
Indonesia: GDPMD Certificate as Mandatory Requirement for e-Catalogue Listing Read More »
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
Indonesia: New Decree concerning the Technical Standards of Short-Range Devices Read More »
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
Andaman Medical: A Partner in Global Diagnostics Company’s Expansion into Malaysia Read More »
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.
