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Regulation Compliance Services

Ensuring that medical devices meet the necessary regulatory requirements set by the FDA for regulatory submissions.

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Wireless

Wireless

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Wireless products: an electrical or electronic product, which intentionally emits and/or receives radio waves for the purpose of radio communication and/or radio determination.

The main directive relevant to wireless products is the Radio Equipment Directive (RED).

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Other directives wireless products may need to comply with are:

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Wireless products to be imported or sold for local use in Singapore are required to be registered with the Infocomm Media Development Authority (IMDA).

EU

SG

Battery

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Battery: Container consisting of one or more cells in which chemical energy is converted into electrical energy and used as a power source.

The main directive relevant to battery products is the *Battery Directive.

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Other directives battery products may need to comply with are: 

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Batteries to be imported or sold for local use in Singapore are required to be registered with the Energy Market Authority (EMA).

EU

SG

Battery
Packaging

Packaging

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Packaging: products made of any materials of any nature to be used for the containment, protection, handling, delivery and/or presentation of goods, from raw materials to processed goods.

EU

SG

The main directive relevant to packaging in the EU is the Packaging and Packaging Waste Directive.

​Producers, brand owners, importers and retailers of packaged products are required to comply to the Mandatory Packaging Reporting (MPR) under the Resource Sustainability Act (RSA).

Radiation

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Radiation: products that emit energy as electromagnetic waves or as moving subatomic particles.

EU

SG

The main directives relevant to radiation related products are:

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Other directives and regulation that radiation related products may need to comply with are:

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Radiation related products are required to comply to the Radiation Protection Act, administrated by the Radiation Protection and Nuclear Science Division (RPNSD) of the National Environment Agency (NEA).

Radiation

Chemicals

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Chemicals: a distinct compound or substance, especially one that has been artificially prepared or purified.

EU

SG

All chemicals imported and produced in Europe must comply to the REACH directive. Another directive that may apply is the RoHS Directive.

Chemical are regulated by the Environmental Protection and Management ACT (EPMA) and the Control of Vectors and Pesticides Act (CVPA), administrated by the National Environment Agency (NEA) and its Chemical Control and Management Department (CCMD).

Chemicals

Medical Devices

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Medical Device: any instrument, apparatus, appliance, software, material or other product, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings.

EU

SG

The main regulation relevant to medical devices is the Medical Device Regulation.

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Other directives medical devices may need to comply with are:

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Medical devices in Singapore are regulated under the Health Products Act and its Health Products (Medical Device) Regulation, overseen the by Health Sciences Authority (HSA).

Medical Devices

In Vitro Diagnostics

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In Vitro Diagnostics: reagents, instruments, and systems used for the purpose of diagnosing disease or other conditions of the human.

The main regulation relevant to In Vitro Diagnostics is the In Vitro Diagnostics Medical Devices Regulation.

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Other directives medical devices may need to comply with are:

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EU

SG

In Vitro Diagnostics in Singapore are regulated under the Health Products Act and its Health Products (Medical Device) Regulation, overseen the by Health Sciences Authority (HSA).

In Vitro Diagnostics

Halal Registration

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Halal Registration and Certification is crucial to gain the confidence and trust of the Muslim market. Gaining Halal Certification provides absolute assurance that an product has been thoroughly checked and abide by the Islamic Shariah Laws. 

SG

MY

Halal Registration and Certification in Singapore are regulated by the Majlis Ugama Islam Singapura (Muis).

Halal Registration and Certification in Malaysia are regulated by the Department of Islamic Development Malaysia (JAKIM).

Halal registraion

Countries

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Learn more about the directives and regulations for medical devices in different counties .

SG

EU

Others

Halal Registration and Certification in Singapore are regulated by the Majlis Ugama Islam Singapura (Muis).

America Certification

African Certifications

Asian Certifications

Australian Certifications

Middle East Certifications 

Halal Registration and Certification in Malaysia are regulated by the Department of Islamic Development Malaysia (JAKIM).

Countries

Any Questions?

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