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Health Sciences Authority (HSA) 🇸🇬

Description

The Health Sciences Authority is a statutory board under the Ministry of Health of the Government of Singapore. It is a multi-disciplinary agency responsible for applying medical, pharmaceutical, and scientific expertise to protect and advance public health and safety.

Official website

http://www.hsa.gov.sg/

TR-02 R3 Contents of a Product Registration Submission for IVD MD using the ASEAN CSDT (2024 Mar) PUB

From Health Sciences Authority (HSA) 🇸🇬

Medical device technical reference document, focusing on product registration submission for IVD medical devices.

Metadata quality:

55.55555555555556/100

Updated on March 1, 2024

Other (Public Domain)

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TR-01 R3 Contents of a Product Registration Submission for GMD using the ASEAN CSDT (2024 Mar) PUB

From Health Sciences Authority (HSA) 🇸🇬

Medical device technical reference document, focusing on product registration submission for general medical devices.

Metadata quality:

55.55555555555556/100

Updated on March 1, 2024

Other (Public Domain)

0 reuses
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GN-18 R3 Guidance on Preparation of a Product Registration Submission for IVD MD using the ASEAN CSDT (2024 Mar) PUB

From Health Sciences Authority (HSA) 🇸🇬

Guidance document on preparing a product registration submission for IVD MD using ASEAN CSDT.

Metadata quality:

44.44444444444444/100

Updated on March 1, 2024

Other (Public Domain)

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GN-17 R3 Guidance on Preparation of a Product Registration Submission for GMD using the ASEAN CSDT (2024 Mar) PUB

From Health Sciences Authority (HSA) 🇸🇬

Provides guidance on preparing a product registration submission for GMD using the ASEAN CSDT.

Metadata quality:

44.44444444444444/100

Updated on March 1, 2024

Other (Public Domain)

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GN-15-R11 Guidance on Medical Device Product Registration (2024 Mar) PUB

From Health Sciences Authority (HSA) 🇸🇬

Provides guidelines on product registration for medical devices.

Metadata quality:

44.44444444444444/100

Updated on March 1, 2024

Other (Public Domain)

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GL-04-R3 Regulatory Guidelines for Software Medical Devices - A Life Cycle Approach (2024 Mar) PUB

From Health Sciences Authority (HSA) 🇸🇬

Document focusing on SaMD specific regulatory guidelines.

Metadata quality:

44.44444444444444/100

Updated on March 1, 2024

Other (Public Domain)

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Health Products (Medical Devices) Regulations 2010

From Health Sciences Authority (HSA) 🇸🇬

Document No. S 436 – Health Products (Medical Devices) Regulations 2010

Metadata quality:

55.55555555555556/100

Updated on December 18, 2023

Other (Public Domain)

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GL-06-R2 Medical Devices Product Classification Guide (2023 Oct) PUB

From Health Sciences Authority (HSA) 🇸🇬

Document focusing on the classification of medical devices.

Metadata quality:

44.44444444444444/100

Updated on October 1, 2023

Other (Public Domain)

0 reuses
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GN-33 R2 Guidance on the Application of Singapore Standard GDPMDS (2023 Sep) PUB

From Health Sciences Authority (HSA) 🇸🇬

Provides guidance on Good Distribution Practice for Medical Devices (GDPMDS).

Metadata quality:

44.44444444444444/100

Updated on September 1, 2023

Other (Public Domain)

0 reuses
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GN-16-R4 Guidance on Essential Principles for Safety and Performance of Medical Devices(2023 Sep) PUB

From Health Sciences Authority (HSA) 🇸🇬

Provides guidance on essential principles for safety and performance of medical devices.

Metadata quality:

44.44444444444444/100

Updated on September 1, 2023

Other (Public Domain)

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GN-07-R3 Guidance on Complaint Handling (2023 Sep) PUB

From Health Sciences Authority (HSA) 🇸🇬

Provides detailed instructions on handling complaints for medical devices.

Metadata quality:

44.44444444444444/100

Updated on September 1, 2023

Other (Public Domain)

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GN-05-R3 Guidance on the Reporting of Adverse Events (2023 Sep) PUB

From Health Sciences Authority (HSA) 🇸🇬

Provides instructions on reporting adverse events for medical devices.

Metadata quality:

44.44444444444444/100

Updated on September 1, 2023

Other (Public Domain)

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Guidance for PHMCA / HCSA Licensees and Telemedicine Service Providers: Advertisement Controls of Health Products and Provision of Non-Promotional Information to the Public

From Health Sciences Authority (HSA) 🇸🇬

Guidance document for PHMCA/HCSA licensees and telemedicine service providers on advertisement controls and providing non-promotional health product information to the public.

Metadata quality:

55.55555555555556/100

Updated on August 21, 2023

Other (Public Domain)

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GN-02-R5 Guidance on Licensing of Manufacturers Importers and Wholesalers of MD (2023 Jul) PUB

From Health Sciences Authority (HSA) 🇸🇬

Covers licensing requirements for manufacturers, importers and wholesalers of medical devices.

Metadata quality:

44.44444444444444/100

Updated on July 1, 2023

Other (Public Domain)

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GN-21-R5 Guidance on Change Notification for Registered MD (2023 Mar) PUB

From Health Sciences Authority (HSA) 🇸🇬

Provides guidelines on change notifications for registered medical devices.

Metadata quality:

44.44444444444444/100

Updated on March 1, 2023

Other (Public Domain)

0 reuses
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GN-35-R4 Guidance on Special Access Routes (2023 Jan) PUB

From Health Sciences Authority (HSA) 🇸🇬

Document providing guidance on special access routes for medical devices.

Metadata quality:

44.44444444444444/100

Updated on March 17, 2024

Other (Public Domain)

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GN-20-R2 Guidance on Clinical Evaluation(2022 Nov)_PUB

From Health Sciences Authority (HSA) 🇸🇬

Provides guidance on Clinical Evaluation, focusing on regulatory requirements and best practices.

Metadata quality:

44.44444444444444/100

Updated on November 1, 2022

Other (Public Domain)

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GN-11-R1.3_Guidance on the Declaration of Conformity(2022 Nov)_PUB

From Health Sciences Authority (HSA) 🇸🇬

Provides guidance on the topic of Declaration of Conformity for medical devices.

Metadata quality:

44.44444444444444/100

Updated on November 1, 2022

Other (Public Domain)

0 reuses
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GN-06-R3 Guidance on Distribution Records(2022 Nov)_PUB

From Health Sciences Authority (HSA) 🇸🇬

Provides insights on Good Distribution Practice for Medical Devices (GDPMDS).

Metadata quality:

44.44444444444444/100

Updated on November 1, 2022

Other (Public Domain)

0 reuses
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Health Products (Supply of Medical Devices — Exemption) Order 2022

From Health Sciences Authority (HSA) 🇸🇬

Document No. S 688 – Health Products (Supply of Medical Devices — Exemption) Order 2022

Metadata quality:

55.55555555555556/100

Updated on September 1, 2022

Other (Public Domain)

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