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.
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 »
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.
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.
We handle the entire registration process, ensuring your medical devices comply with local regulations.
We handle the entire registration process, ensuring your medical devices comply with local regulations.
We handle the entire registration process, ensuring your medical devices comply with local regulations.
We handle the entire registration process, ensuring your medical devices comply with local regulations.
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 »
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’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
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
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 »
