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Malaysia: MDA’s Approach to Expired EC Certificates and Self-Declared for New Registration and Re-Registration of Class B IVD Medical Devices

Leave a Comment / Malaysia, Regulatory updates / By Kia UP

The Medical Device Authority of Malaysia (MDA) has announced that expired EC Certificates under certain EU Directives (90/385/EEC, 93/42/EEC, 98/79/EC) or declarations of conformity for Class B IVD devices under Directive 98/79/EC can be used for conformity assessment by registered conformity assessment bodies (CABs). This approach addresses delays in transitioning to the EU MDR and […]

Malaysia: MDA’s Approach to Expired EC Certificates and Self-Declared for New Registration and Re-Registration of Class B IVD Medical Devices Read More »

Andaman Medical Indonesia Celebrates Independence Day with Enthusiasm and Team Spirit

Leave a Comment / Events & Other News, Indonesia / By andamanmedical

Last week, Andaman Medical’s Indonesian team came together to celebrate a significant milestone in the nation’s history—Indonesia’s Independence Day. The 17th of August is more than just a date on the calendar; it’s a day that commemorates the hard-won freedom of the Indonesian people, and this year, our team honoured it with a celebration full

Andaman Medical Indonesia Celebrates Independence Day with Enthusiasm and Team Spirit Read More »

Vietnam: Announcement Regarding the Update of Documents on the DMEC System

Leave a Comment / Regulatory updates, Vietnam / By Kia UP

On August 16, 2024, the Department of Medical Infrastructure and Equipment issued an announcement to registration facilities regarding the update of documents on the DMEC website. The Department requires registration facilities to follow up the processing progress and update the documents on the system as per the following guidelines: Instructions for updating documents related to

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Thailand: FDA Shares Information for the Registration of Monkeypox Diagnostic Test

Leave a Comment / Regulatory updates, Thailand / By Kia UP

On August 20, 2024, Thailand FDA published an infographic about the registration of diagnostic tests for Monkeypox (Mpox) in Thailand. The information shared is as follows: ● Monkeypox Diagnostic Test is categorized as Medical devices for in vitro diagnostics (IVD) group and classified as Notify medical devices (Class B or C portal). ● Documents for

Thailand: FDA Shares Information for the Registration of Monkeypox Diagnostic Test Read More »

Cambodia

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IVDs regulated by Ministry of Health as medical devices
4 risk classes (A-D) aligned with ASEAN MDD
All IVDs require registration; some additional requirements for HIV and COVID tests
MoH total review timeline: 45-80 working days based on risk class

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Singapore

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IVDs regulated by Ministry of Health as medical devices
4 risk classes (A-D) aligned with ASEAN MDD
All IVDs require registration; some additional requirements for HIV and COVID tests
MoH total review timeline: 45-80 working days based on risk class

Singapore Read More »

Indonesia: Minister of Health Issued a New Regulation Pertaining to Guidelines on Halal Manufacturing Methods for Drugs, Biological Products, and Medical Devices, as well as the Inclusion of Information on the Origin of Ingredients for Medical Devices

Leave a Comment / Indonesia, Regulatory updates / By Kia UP

The Minister of Health of Indonesia has established regulation Number 3 of 2024 about Guidelines on Halal Manufacturing Methods for Drugs, Biological Products, and Medical Devices, as well as The Inclusion of Information on The Origin of Materials for Medical Devices on 5th March 2024 and stipulated on 2nd April 2024. To ensure the achievement

Indonesia: Minister of Health Issued a New Regulation Pertaining to Guidelines on Halal Manufacturing Methods for Drugs, Biological Products, and Medical Devices, as well as the Inclusion of Information on the Origin of Ingredients for Medical Devices Read More »

Philippines: PFDA Shares the Guidelines for the Pilot Implementation of the FDA eServices Portal System for the Initial Application of CMDN within the National Capital Region (NCR)

Leave a Comment / Philippines, Regulatory updates / By Kia UP

On August 2, 2024, the Food and Drug Administration (FDA) released an advisory regarding the implementation guidelines for a platform for submitting CMDN applications. FDA is currently developing the FDA eService’s Portal System – an online platform for a streamlined initial application of a Certificate of Medical Device Notification (CMDN). As part of this plan,

Philippines: PFDA Shares the Guidelines for the Pilot Implementation of the FDA eServices Portal System for the Initial Application of CMDN within the National Capital Region (NCR) Read More »

Potential Market Entry and Expansion

Leave a Comment / Uncategorized / By andamanmedical

Successfully registering your IVD device is the first step towards establishing a strong market presence in Indonesia. It enables collaborations with local distributors, healthcare institutions, and government programs. Additionally, it lays the foundation for future product launches and market expansion strategies.

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Regulatory Compliance

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Registering your IVD device ensures compliance with the regulatory requirements set by the Indonesian Ministry of Health. This compliance not only helps in avoiding legal issues but also builds trust and credibility with healthcare providers.

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Access to a Growing Market

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The demand for advanced diagnostic solutions is on the rise in Indonesia, driven by increased healthcare spending and a growing awareness of the importance of early disease detection. By registering your IVD device in Indonesia, you tap into a large and emerging market with significant growth potential.

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Partnering Opportunities

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Vietnam’s growing healthcare sector is attracting numerous local and international investors and partners. Having your IVD device registered can open doors to strategic partnerships with local distributors, hospitals, and clinics, further enhancing your market penetration and business growth.

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Market Access and Distribution

Leave a Comment / Uncategorized / By andamanmedical

Registration facilitates smoother market access and distribution of your IVD devices across Vietnam. With proper registration, you can avoid potential legal issues, delays, and disruptions in supply chains, ensuring that your products reach healthcare providers efficiently.

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Regulatory Compliance

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Registering your IVD device in Vietnam ensures compliance with local regulatory requirements, which is crucial for legal marketing and distribution. Adhering to the regulations set by the government demonstrates your commitment to quality and safety, enhancing your brand’s reputation.

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Vietnam: Promulgation of Guidelines for the Evaluation of Legal Documents for Registration Dossiers of Medical Device Class C & D

Leave a Comment / Regulatory updates, Vietnam / By Kia UP

On August 5th 2024, the Vietnam Ministry of Health (MoH) issued Decision No. 2302/QD-BYT regarding the promulgation of Guidelines for the Evaluation of Legal Documents for Registration Dossiers of Medical Device Class C and D. This decision replaces Decision No. 3007/QĐ-BYT dated November 3, 2022. There are no changes to the legal documentation component for

Vietnam: Promulgation of Guidelines for the Evaluation of Legal Documents for Registration Dossiers of Medical Device Class C & D Read More »

Strategic Location in Southeast Asia

Leave a Comment / Uncategorized / By andamanmedical

Thailand’s strategic location serves as a gateway to other Southeast Asian markets. Successful registration and commercialization of IVD devices in Thailand can facilitate expansion into neighboring countries, leveraging the established regulatory and distribution frameworks.

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Regulatory Compliance and Market Credibility

Leave a Comment / Uncategorized / By andamanmedical

Registering your IVD device with the Thai Food and Drug Administration (Thai FDA) ensures compliance with local regulations, enhancing your product’s credibility and acceptance in the market. Compliance with stringent regulatory standards demonstrates your commitment to safety, efficacy, and quality, which can significantly boost your reputation among healthcare providers.

Regulatory Compliance and Market Credibility Read More »

Expanding Market Opportunities

Leave a Comment / Uncategorized / By andamanmedical

Thailand’s IVD market is one of the largest in Southeast Asia, showing strong growth due to the increasing demand for advanced diagnostic solutions. By registering your IVD device in Thailand, you gain access to a market that is continuously expanding, driven by the need for improved healthcare services and innovative diagnostic technologies.

Expanding Market Opportunities Read More »

Long-Term Growth

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With the increasing demand for quality healthcare services and diagnostic solutions, the Philippines offers significant opportunities for long-term growth. Registering your IVD devices ensures you are well-positioned to capitalize on future market developments and expand your presence in this dynamic region.

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Credibility and Trust

Leave a Comment / Uncategorized / By andamanmedical

Obtaining FDA approval for your IVD devices enhances your credibility and trustworthiness in the eyes of healthcare professionals, patients, and business partners. It demonstrates your commitment to providing safe and effective diagnostic tools, thereby boosting your reputation and brand value.

Credibility and Trust Read More »

Market Access

Leave a Comment / Uncategorized / By andamanmedical

The Philippines is one of the fastest-growing markets in Southeast Asia with a rapidly expanding healthcare sector. Registering your IVD device allows you to tap into this burgeoning market, providing access to a large and diverse patient population in need of advanced diagnostic solutions.

Market Access Read More »

Medical Tourism Hub

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Malaysia is recognized globally as a leading medical tourism destination. This status not only boosts the demand for high-quality medical devices but also ensures a steady influx of international patients seeking advanced diagnostic solutions.

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Favorable Business Environment

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Malaysia offers a business-friendly environment with various incentives for foreign manufacturers. The country’s robust infrastructure, skilled workforce, and supportive government policies make it an attractive destination for medical device companies.

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Regulatory Compliance

Leave a Comment / Uncategorized / By andamanmedical

Malaysia’s regulatory framework for medical devices, overseen by the Medical Device Authority (MDA), a federal statutory agency under the Ministry of Health (MoH), 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 in other markets.

Regulatory Compliance Read More »

Growing Market

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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.

Growing Market Read More »

Legal Protection

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Proper registration provides legal protection for your product. It helps in defending against counterfeit products and ensures that your intellectual property rights are safeguarded.

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Facilitates Import and Export

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Registered devices can be imported and exported more smoothly, as they meet the regulatory requirements of Cambodia. This can streamline your supply chain and reduce delays in getting your products to market.

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Brand Reputation

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A registered IVD 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.

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Regulatory Compliance

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Compliance with Cambodian regulations ensures that your IVD 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.

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Market Access

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Registering your IVD device grants you legal access to the Cambodian market. Without proper registration, you cannot legally sell or distribute your products within the country.

Market Access Read More »

August 2024

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