Facilitates Import and Export
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.
Brand Reputation
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.
Regulatory Compliance
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.
Market Access
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.
Well-Established Healthcare Infrastructure
Singapore’s healthcare infrastructure continually evolves to incorporate the latest advancements in medical technology. This environment not only supports the adoption of innovative IVD devices but also provides a seamless platform for clinical validation and real-world testing.
Potential for Faster Market Entry in Southeast Asia
Singapore’s strategic location and its status as a leading business hub in Southeast Asia make it an excellent starting point for regional market expansion. Successful registration in Singapore can expedite the approval process in other Southeast Asian countries.
Potential for Faster Market Entry in Southeast Asia Read More »
Stringent Regulatory Standards
Singapore’s regulatory standards are among the highest in the world. The HSA adheres to stringent regulations that align closely with international best practices. This ensures that your product meets global quality and safety standards, which can be a significant selling point when marketing your device locally and internationally.
Access to a Growing Market
Singapore is renowned for its advanced healthcare system and cutting-edge medical technologies. Registering your IVD device in Singapore means gaining access to a market that values innovation and has the purchasing power to invest in high-quality diagnostic tools.
Philippines
- 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
Thailand
- 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
Vietnam
- 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
Malaysia
- 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
Indonesia
- 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
Post Market Surveillance
We handle the entire registration process, ensuring your medical devices comply with local regulations.
Regulatory Intelligence
We handle the entire registration process, ensuring your medical devices comply with local regulations.
Authorized Representation
We handle the entire registration process, ensuring your medical devices comply with local regulations.
Device Registration
We handle the entire registration process, ensuring your medical devices comply with local regulations.
Vietnam: MoH Shares New Draft Law on Medical Devices in Vietnam
From a conference attended by Andaman Vietnam team on July 11, 2024, the Ministry of Health announced that they are preparing to submit to the Government a draft Law on Medical Devices by December 2024. Currently, medical devices in Vietnam are under the management of some valid regulations such as: Decree 98/2021/ND-CP; Decree 07/2023/ND-CP and
Vietnam: MoH Shares New Draft Law on Medical Devices in Vietnam Read More »
Thailand: Five Things to Be Aware of Regarding Notification of Advertisement of Medical Devices Direct to Healthcare Professionals That Is Exempt from Authorization
Last July 24, 2024, Thailand FDA released an infographic about Advertisement of Medical Devices Direct to Health Professionals. The summary of the information is as follows: Advertising medical devices that are exempt from authorization to healthcare professionals is a form of direct advertising with specific characteristics and methods aimed only at healthcare and public health
Indonesia: Government Regulation No. 28 of 2024 concerning Implementing Regulations for Law No. 17 of 2023 Concerning Health in Indonesia
Indonesia’s government has officially issued Government Regulation No. 28 of 2024 concerning Implementing Regulation for Law No. 17 of 2023 concerning Health has been officially signed by Indonesia President, Joko Widodo on 26 July 2024. In order to increase health capacity and resilience within the framework of Health transformation to achieve its improvement the highest
Indonesia: Appeal for Filling in Pharmacy and Medical Device Dictionary Data (KFA: Kamus Farmasi dan Alat Kesehatan)
On July 26, 2024, the Indonesia Ministry of Health (MoH) issued a letter numbered FR.01.01/E.V/1652/2024 regarding the Appeal for Filling in Pharmacy and Medical Device Dictionary Data (KFA). The Satu Sehat Logistik Platform (National Digital Inventory) is a platform for stock monitoring national drugs and Medical Consumable (BMHP: Barang Medis Habis Pakai) as well as
Indonesia: Appeal for Filling in Medical Device Dictionary Data
On July 16, 2024, the Indonesia Ministry of Health (MoH) issued an announcement letter No. FR.01.01/E.V/1537/2024 regarding the Appeal for Filling in Medical Device Dictionary Data. The MoH has again requisitioned all companies holding active product licenses for medical devices to fill in the Pharmacy and Medical Devices Dictionary (KFA) to increase health resilience and
Indonesia: Appeal for Filling in Medical Device Dictionary Data Read More »
Malaysia: Pilot Survey for Unique Device Identification (UDI)
On June 7th, MDA launched the first phase of the pilot survey for the implementation of Unique Device Identification (UDI) in Malaysia. The survey will be conducted in two phases, involving the following establishments and timelines (dates updated July 30 2024): Phase 1: Class D Medical Device Establishments – June 7, 2024, to August 15,
Malaysia: Pilot Survey for Unique Device Identification (UDI) Read More »
Thailand: FDA Released Draft Guidelines for Referencing Existing documents, Document Transfer, or other cases in Submitting Applications for Manufacture or Import Licenses, and Notifications for Manufacture or Import of Medical devices
On July 9, Thai FDA shared the following draft guidelines regarding license transfer and brand name amendment: The guidelines are set up for the applications that are eligible for referencing existing documents or document transfer from approval license which do not require an expert review of the documents. It covers three main scenarios: (1) When
Thailand: Arrangement of Signage for Facilities Involved in Importing/Manufacturing/Selling/Storage of Medical Devices
On July 10, Thai FDA shared an infographic regarding signage requirement for affected stakeholders: The registrants of an establishment for manufacturing or importing/licensed sellers of medical devices must arrange for signage display. The Signage must be displayed for the following: Medical device manufacturing facility Medical device selling facility Medical device importing facility Medical device storage
The Philippines: PFDA Temporary Suspends LBP Oncoll Payment Facility and Addresses Payment Issues for Some Applications
Starting 01 July 2024, Payment via over-the-counter using LBP Oncoll Deposit Slip will be temporarily suspended until further notice. During this period, FDA encourages all concerned parties to utilize the following payment channels: LBP LinkBiz Portal DBP BancNet Bills Payment Over the Counter (for applications included in the Annexes of FDA Advisory No. 2024-0320) Furthermore, the
Vietnam: New Circular Regulating Fees and Charges Affecting the Medical Sector
On 28 June 2024, the Vietnam Ministry of Finance issued Circular No. 43/2024/TT-BTC prescribing fees and charges to remove further difficulties for enterprises and support production and business activities. This circular reduces the fees and charges for some procedures from those regulated in previous guidelines. Accordingly, all fees and charges in the medical sector are
Vietnam: New Circular Regulating Fees and Charges Affecting the Medical Sector Read More »
Thailand: TFDA released list of experts, organizations, government agencies, and private organizations to evaluate academic documents on medical devices
In an announcement last June 26, 2024, TFDA released an additional list of experts, expert organizations, government agencies, or private organizations, both domestic and international, to perform the evaluation of academic documents on medical devices. This is according to Section 35/2, paragraph 1 of the Medical Devices Act B.E. 2551, as amended by the Medical
Thailand: Classifying Massage Equipment and Vibrating Devices as Medical Devices
Massage equipment and vibrating devices are commonly used for various purposes, but not all of them are classified as medical devices. The classification depends on their intended use and the claims made by the manufacturer. Here’s a breakdown of how these devices are classified according to the Medical Device Act B.E. 2551 (2008), as amended
Thailand: Classifying Massage Equipment and Vibrating Devices as Medical Devices Read More »
Thailand: Draft Announcement of Guidelines for Submitting Applications for Medical Device Advertisement that Requires Academic Document Evaluation
On May 20, 2024, the Ministry of Public Health of Thailand issued a notification regarding medical devices prohibited from direct sales or direct marketing under the law governing Direct Sales and Direct Marketing. By Section 5, Paragraph One, and Section 6 (12) of the Medical Device Act B.E. 2551 (2008), the Minister of Public Health,