Laws
Health Products (Medical Devices) Regulations 2010
reg 5

In forceAs enactedCurrent version · As enactedSee versions on Singapore Statutes Online(opens the publisher’s site)

Contents

Health Products (Medical Devices) Regulations 2010

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IPreliminary

VAdvertisement of Medical Devices

XMiscellaneous

4 regulations earlier

3BManufacture of laboratory-developed tests
3CManufacture of Class A medical devices for charitable purposes
3DManufacture of specified dental medical devices
4Manufacture of medical devices by way of secondary assembly
4AImport of medical devices for personal use
4BImport of medical device licensed under Radiation Protection Act
4CImport of medical device for use in clinical research
4DRequirements for issue of wholesaler’s licence
5Wholesaling of self-manufactured medical devices
5AWholesaling of medical device licensed under Radiation Protection Act
5BWholesaling of medical device for use in clinical research
6Exception for custom-made medical devices, etc.
7Exception for medical devices which underwent maintenance or repair
8Exception for medical devices for patients’ use
9Exception for export or re-export
10Exception for non-clinical use
10AException for clinical research
10BException for Class A medical devices
11Exceptions for phased implementation of prohibition
11AException for import of medical device by licensed manufacturer without importer’s licence
11BException for wholesale of medical devices to ships or aircraft by licensed importer without wholesaler’s licence
11CPreviously registered medical devices
12Supply of Class A medical devices
13Supply of “professional use only” medical devices
13ASupply of medical devices for use in clinical research

38 regulations later

Schedules

Health Products (Medical Devices) Regulations 2010 · As enacted

5. Wholesaling of self-manufactured medical devices

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Official textFrom Singapore Statutes Online, unchanged

A licensed manufacturer who manufactures a medical device may supply that medical device by wholesale without holding a wholesaler’s licence under section 14(1) of the Act.

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Read on from reg 5A

Schedules

Read on from Schedules

Details

Health Products (Medical Devices) Regulations 2010 · reg 5

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Where this comes from

Singapore Statutes Online · Health Products (Medical Devices) Regulations 2010, As enacted. Reader record updated on 2 Aug 2026.

Singapore legislation is Government copyright, used with the permission of the Attorney-General’s Chambers. Check Singapore Statutes Online for the latest version.

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