[PDF] singapore medical device classification

medical-devices-product-classification-guide.pdf

some countries it will also be a medical device in Singapore. This is not the case and the definition of MD should always be referred to

Guidance on the Risk Classification of General Medical Devices

1 Sept 2018 Deletions may not be shown. Page 4. MEDICAL DEVICE GUIDANCE. SEPTEMBER 2018. HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP.

MEDICAL DEVICE GUIDANCE

2 Jun 2018 This document provides guidance to assist product owners in risk classification of in vitro diagnostic (IVD) medical devices using the ...

MEDICAL DEVICES PRODUCT CLASSIFICATION GUIDE

some countries it will also be a medical device in Singapore. This is not the case and the definition of MD should always be referred to

Guidance for Dealers on Class A Medical Devices Exempted from

1 Jan 2019 Class A medical devices are exempted from registration with HSA prior to placement on the Singapore market. Product registration requirement ...

GN-22: Guidance for Dealers on Class A Medical Devices Exempted

22 Mar 2021 Class A medical devices are exempted from registration with HSA prior to placement on the Singapore market. Product registration requirement ...

MEDICAL DEVICE GUIDANCE

3 Oct 2020 Class A medical devices are exempted from registration with HSA prior to placement on the Singapore market. Product registration requirement ...

MEDICAL DEVICE GUIDANCE - GN-15

5 Aug 2021 REGISTRATION OF CLASS C AND D MEDICAL DEVICES . ... in Singapore should also comply with the requirements under other applicable.

REGULATORY GUIDELINE FOR TELEHEALTH PRODUCTS

Flowchart 2: Risk Classification of Telehealth Medical Devices In order to supply a Telehealth medical device in Singapore the company is required to.

MEDICAL DEVICE GUIDANCE

3 Feb 2020 HSA has made updates for IVD analysers concerning their risk classification grouping

MEDICAL DEVICES PRODUCT CLASSIFICATION GUIDE

MEDICAL DEVICE means: Anyinstrument apparatus implement machine appliance implant reagent forinvitrouse softwarematerial orothersimilarorrelatedarticlethat isintendedbyitsmanufacturer tobeused whetheraloneorincombination forhumansforoneormoreof thespecificpurposesof – Diagnosis prevention monitoring treatment or alleviateof disease;

Regulatory Updates Health Sciences Authority Singapore

presents the current regulatory requirements for such software medical devices The guideline was published for consultation in 2021 and the finalised version incorporating stakeholders’ feedback and comments has been published in April 2022 This document can be accessed online at: https://www hsa gov sg/medical-devices/guidance-documents

ASEAN MEDICAL DEVICE DIRECTIVE - Asia Actual

Nov 22 2020 · ARTICLE 4 CLASSIFICATION OF MEDICAL DEVICES (1) Medical devices shall be classiied into the following four classes in accordance with risk classiication rules set out in Annex 2 (Risk Classiication Rules for Medical Devices other than IVD Devices) and Annex 3 (Risk Classiication Rules for IVD Devices): Class Risk Level

Singapore - Baker McKenzie

Class C and D medical devices (but excluding those medical devices currently licensed under the Radiation Protection Act by the Centre for Radiation Protection and Nuclear Science of the National Environment Agency) that are imported and supplied must meet on of the criteria below: Listed on the Singapore Medical Device Register;

Are medical devices regulated in Singapore?

Medical devices are regulated under the Health Products Act and Health Products (Medical Devices) regulations. Singapore’s Health Sciences Authority (HSA) oversees the system of statutory control aimed to safeguard the quality, safety and efficacy of medical devices available in Singapore. Almost all medical devices are regulated.

What is not considered a medical device?

Similarly, products intended for physical fitness, maintenance of general state of health (ie. weight management, recreational use, sleep management, detoxification, improving and enhancing flow of (qi) are not considered medical devices. PRODUCT(S) CLASSIFICATION REMARKS

Should ASEAN countries adopt uniform classification criteria for medical devices?

This requires ASEAN countries to adopt uniform classification criteria for medical devices. This bodes well for U.S. medical device manufacturers as they will be able to easily access a common medical device market with a market size of more than 600 million people.

Who buys medical equipment in Singapore?

The Health Ministry is the largest consumer, accounting for nearly 75% of local demand. Parkway Hospitals Singapore, the largest private sector healthcare provider in Singapore, is also a significant buyer of medical equipment. More than 80% of local demand is met through imports and there is a premium placed on American-made products.