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Singapore

Wireless SG

Types of Telecommunication Dealer’s License

  • Dealer’s Class License ($50 one-time license fee payment for life): Allows the licensee to import or sell for local use registered telecommunication equipment or equipment not requiring approval (e.g. single line telephones).

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  • Dealer’s Individual License ($250 license fee for 5 years): Allows the licensee to import or sell

    1. Registered telecommunication equipment or equipment not requiring approval for use in Singapore or,

    2. Non-registered telecommunication equipment for re-export purposes.

Wireless

Types of Telecommunication Dealer’s License

  • Dealer’s Class License ($50 one-time license fee payment for life): Allows the licensee to import or sell for local use registered telecommunication equipment or equipment not requiring approval (e.g. single line telephones).

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  • Dealer’s Individual License ($250 license fee for 5 years): Allows the licensee to import or sell

    1. Registered telecommunication equipment or equipment not requiring approval for use in Singapore or,

    2. Non-registered telecommunication equipment for re-export purposes.

Compliance Label

  • Licensees are required to affix compliance label on registered telecommunication equipment OR its instruction manual or packaging OR electronic labelling (equipment’s built-in display screen or softcopy instruction manual).

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  • Purpose: Facilitates easy identification of approved/registered equipment for use in Singapore AND identifies the registering equipment supplier.

Equipment Registration Framework

Telecommunication Dealer’s Licensees who intend to sell telecommunication equipment for local use in Singapore are required to register the equipment with IMDA. Equipment shall comply with IMDA Standards before registering it with IMDA, to ensure network compatibility and prevent radio frequency interference to other authorised radio-communication stations/networks.

Equipment Registration Schemes

  • Simplified Equipment Registration (“SER”)

    1. Self-declaration - suppliers carry out own conformity assessment to IMDA standards.

    2. Applies to equipment whose standards have been largely harmonised worldwide, and which requires checking of a few key parameters by IMDA before granting approval.

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  • Enhanced Simplified Equipment Registration (“ESER”)

    1. Based on a declaration of conformity that does not need prior verification by IMDA.

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  • General Equipment Registration (“GER”)

    1. Declaration evaluated by IMDA: Applies to equipment with high potential for causing radio interference and equipment of new technologies yet to be stabilised.

    2. Declaration certified by IMDA recognised Certification Body (CB): Applies to registration of telecommunication equipment by CBs under the Mutual Recognition Arrangement (MRA) Phase II.

IMDA’S Requirements for importation of Wireless Telecommunication Devices for Clinical Trials

  • Importers of telecommunication devices (limited to wireless devices such as tablets and mobile phones) into Singapore for the purpose of conducting clinical trials will no longer be required to apply for a Technical Trial Permit from IMDA.

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  • However, importers shall need to indicate the purpose of importing such devices when declaring the imports via TradeNet and indicate whether local or overseas SIM cards are used, and if so, indicate the name(s) of the local or overseas telecommunication service provider(s).

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  • For those who are hand-carrying the telecommunication devices into Singapore to conduct clinical trials, please provide the relevant information (i.e. contact details, details of import, purpose of import, duration and location of trial, etc) and whether local or overseas SIM cards are used, and if so, indicate the name(s) of the local or overseas telecommunication service provider(s) to email: tlsinfo@imda.gov.sg for IMDA’s information.

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  • If the equipment used for the trial is to be imported/sold for use in Singapore after the trial, the person/company importing/selling the equipment would need to:​

    1.  Apply for the Telecommunication Dealer’s Licence from IMDA, to import and sell the equipment, and

    2. Register the equipment with IMDA, to ensure that the equipment is compatible with the public networks.

    3. Otherwise, the equipment should be exported and returned to overseas supplier.

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  • As far as possible, please use the telecommunication services provided by authorized public network service providers (e.g. Singtel Mobile, M1, StarHub Mobile, etc.) for the clinical trial and for any subsequent service.

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  • Do ensure that the collection, use, retention and disclosure of any personal data comply with the requirements under the Personal Data Protection Act (PDPA), prior to and after the trial.

Reference:

[1] IMDA

Radiation SG
Battery SG

Battery SG

Packaging SG

Mandatory Packaging Reporting (MPR) under Resource Sustainability Act (RSA)

Background & Objective

Packaging waste, including plastics, makes up about one-third of domestic waste disposed of in Singapore. It is therefore one of the key waste streams to focus on for more sustainable waste management, to help Singapore achieve its goal of towards becoming a Zero Waste Nation.

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Mandatory packaging reporting (MPR) aims to raise companies’ awareness of the benefits of packaging reduction and to spur companies to reduce the amount of packaging used. It will lay the foundation for an Extended Producer Responsibility (EPR) framework for packaging waste management, which will be implemented no later than 2025.

What the Mandatory Packaging Report entails

Under the Mandatory Packaging Reporting (MPR) framework, producers of packaged products, such as brand owners, manufacturers, and importers, as well as retailers such as supermarkets, will be required to submit packaging data and 3R plans to the NEA annually. Companies will have to provide information on the packaging placed on the Singapore market, broken down according to type of packaging material (e.g. plastic, paper, metal, glass), packaging form (e.g. carrier bags, bottles) and the corresponding weights.

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The 3R plans that companies are required to submit will have to include details of key initiatives, key performance indicators (KPIs) and targets. Companies will be required to report on the progress of these plans in subsequent years of reporting. The types of 3R plans for packaging that companies could consider include:

  1. packaging reduction

  2. packaging collection for reuse or recycling

  3. consumer or industry outreach related to packaging 3Rs

  4. use of recycled content in packaging material

  5. improvements in recyclability of packaging.

Timeline for 2022 reporting

For the first report to be submitted in 2022, producers (with an annual turnover of more than S$10 million in 2020) will need to report data on the amount of packaging imported/used in 2021 and develop 3R plans to be submitted by 31 March 2022.

Packaging reporting timeline 2022.jpg

Types of packaging that requires reporting

Packaging refers to all 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. Common types of packaging materials include glass, metal, paper and plastic. Packaging covered under the mandatory packaging reporting include:

Types of Packaging.png

Companies that requires reporting

  • Carries on a business of supplying regulated goods* in Singapore

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  • Meet the prescribed threshold criteria which is an annual turnover of more than S$10 million

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  • Imports or uses specified packaging**

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*Regulated goods means any goods other than goods prescribed as excluded from this definition (please refer to Subsidiary Legislation)

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**Specified packaging means any packaging other than any type of packaging prescribed as excluded from this definition (please refer to Subsidiary Legislation)

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The table below summarizes which types of companies are required to report the different types of packaging covered under the reporting framework.

Which packaging is covered.png

Offenses and Penalties

Packaging offenses.jpg

Reference:

[1] National Environmental Agency (NEA) Mandatory Packaging Reporting

Radiation SG

Medical Devices/IVD SG

Medical devices in Singapore are regulated under the Health Products Act and its Health Products (Medical Device) Regulation, overseen by the Health Sciences Authority (HSA). Medical device dealers must be registered with Accounting and Corporate Regulatory Authority (ACRA). 

  • There are 2 possible applications which can be done simultaneously: 

    1. Product registration: to obtain marketing clearance for the product’s import and supply in Singapore.

    2. Dealer’s license: obtain clearance to engage in the manufacture, import and/or wholesale of medical devices in Singapore.

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  • Successful applicants will receive a certification and be listed on the Singapore medical device register.

Medical Device Definition

  • Medical devices are health products which have a physical or mechanical effect when used on human bodies. These devices are used to:

    1. Diagnose, alleviate or treat a medical condition, e.g. X-ray machines, contact lenses, prosthetic knee implants​

    2. Measure or monitor functions of the body, e.g. blood pressure or blood sugar monitoring machines

Product Registration

  • Determine the risk classification of the medical device, either class A, B, C or D. Medical devices in class A do not require product registration. The risk classification of each medical device depends on the design and claims made by the product owner and on its intended purpose.

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  • Classification of general medical devices are governed by 16 classification rules, and In Vitro Diagnostic Devices are governed by 7 classification rules. 

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  • Each device registration is done via a specific evaluation route which depends on:

    1. Risk classification of the device

    2. Number of prior approvals given by our overseas reference regulatory agencies

    3. Duration of the device’s safe marketing history

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  • Evaluation routes:

    1. Full, Abridged, Expedited, Immediate

    2. Priority review route: applies for Class B, C and D devices that are submitted under the full evaluation route, and excludes Class D devices with a registrable drug in a secondary role.​

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Scheme 1: Designed and validated for an unmet clinical need for one of the 5 healthcare areas – cancer, diabetes, ophthalmic diseases, cardiovascular diseases, and infectious diseases.

Scheme 2: The medical device does not meet the above two criteria.

SG medical devices table - evaluation routes, condition, fees and turnaround time.png

*Reference regulatory agencies: Australia Therapeutic Goods Administration (TGA), European Union Notified Bodies (EU NB), Health Canada (HC), Japan Ministry of Health, Labor and Welfare (MHLW), US Food and Drug Administration (US FDA)

Dealer’s license application

  • Although class A medical devices are exempted from product registration, a dealer’s license application is still needed, along with the completion of the Class A Exemption List in MEDICS.

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  • Dealer Licensing

    1. Manufacturer’s license: Manufacture of medical devices in Singapore

    2. Importer’s License: Import of medical devices into Singapore

    3. Wholesaler’s License: Wholesale of medical devices in Singapore (including export)

SG medical device dealer license requirements.png

Fees and turnaround time for dealer's license

  • New application: $1,030 & 10 days

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  • Annual renewal: $1,030 & 10 days

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  • Dealer's license amendment: $155 & 10 days

* Licenses are valid for 12 month from the date of license approval. Renewal of licenses must be submitted and processed before the expiry.

Reference: HSA website, https://www.hsa.gov.sg/medical-devices/registration

Chemicals SG

Battery Energy Storage Systems (BESS)

Regulated in SIngapore, overseen by the Energy Market Authority (EMA).

 

BESS includes,

  • Flow Battery Redox/Hybrid

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  • Lead Acid Battery

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  • Lithium-ion Battery

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  • Nickel-based Battery

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  • Sodium Battery

Common BESS regulatory requirements:

  • Fire safety certification

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  • Electrical installation License

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  • Electricity generation or Wholesaler License

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  • Connection to the power grid

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  • Market Participation

Electricity Generation / Wholesaler License

Under EMA’s current regulatory framework, the type of license required by the BESS, where one unit of BESS is defined as one or more batteries connected to a single PCS, is dependent on the nameplate rating of the BESS.

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  • Any person who owns a BESS that is either directly or indirectly connected to the grid will be required to be licensed under an Electricity Generation License, or Wholesaler License, based on the following:

BESS table.PNG

Fire Safety Certification 

  • Under the Fire Safety Act, the owner of the BESS has to engage a Qualified Person (“QP”) who is a registered architect or professional engineer. The appointed QP is required to seek SCDF’s approval on the plan for fire safety works before the installation of BESS.

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  • Once the works are completed in accordance with SCDF’s requirements, the owner will need to engage a Registered Inspector (“RI”) to inspect and certify the fire safety works. With the Inspection Certificate issued by the RI, the QP can then apply for the Fire Safety Certificate through SCDF, on behalf of the owner.

Electrical Installation License

  • Under the Electricity Act, an Electrical Installation (“EI”) License is required for all non-domestic electrical installation with approved load exceeding 45 kilovolt-amperes (“kVA”). It is a requirement for owners of electrical installations to appoint a Licensed Electrical Worker5 (“LEW”) to take charge of their electrical installations.

Connection to Power Grid

  • The connection of the BESS to the power grid for all new or existing installations will require the appointed Licensed Electrical Worker ("LEW") to complete an online application form and submit the relevant documents to SP Services (“SPS”) via SP’s eBusiness Portal.

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  • Thereafter, the LEW will need to consult SP PowerGrid (“SPPG”) on the connection schemes and technical requirements.

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  • This is important for the purpose of ensuring power system stability, both at the localised and system level.

Market Participation

  • Under the existing Market Rules, the BESS is required to be registered with Energy Market Company ("EMC") as a Market Participant (“MP”)7 if the owner wishes to participate in the wholesale market and provide ancillary services.

Reference: 

[1] Handbook for Energy Storage Systems

Packaging SG
Chemicals SG

RADIATION PROTECTION (AMENDEMENT) ACT 2014

An Act to control and regulate the import, export, manufacture, sale, disposal, transport, storage, possession and use of radioactive materials and irradiating apparatus, to make provision in relation to the non-proliferation of nuclear weapons, to establish a system for the imposition and maintenance of nuclear safeguards, and to implement the Convention on the Physical Protection of Nuclear Material, and to provide for matters connected therewith.

The Radiation Protection Act is administrated by the Radiation Protection and Nuclear Science Division (RPNSD) of the National Environment Agency (NEA).

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Under this Act, there are 4 sets of Regulations:

  • Radiation Protection (Ionising Radiation) Radiation Regulations 2000

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  • Radiation Protection (Non-Ionising Radiation) (Amendment) Regulations 2019

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  • Radiation Protection (Transport of Radioactive Materials) Regulations 2000

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  • Radiation Protection (Exemption for Transit, Transshipment and Carriage of Conveyance Equipment) Regulations 2014

Ionising Radiation Regulations

  • Anyone engaged in radiation work must have a license or be registered as a radiation worker and he should wear a personal monitoring device to monitor the amount of radiation received in the course of his work.

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  • The licensee should ensure that each irradiating apparatus and each container of radioactive material is properly labelled with the radiation hazard logo.

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  • Radioactive materials should be stored in a safe and secured place. Outside the defined area where the radioactive materials are stored, the radiation levels must not exceed 0.5 µSv/hr.       

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Non-Ionising Radiation Regulations

  • Concerns over the safety of microwave ovens, lasers and ultrasonic devices were increasingly being used in domestic, industrial, and medical applications.

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  • Lasers that are used for the purpose of in vivo diagnostic, surgical, therapeutic laser irradiation of any part of the human body are classified as medical lasers under the Act.

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  • With that, control over these potentially hazardous non-ionising radiation (NIR) devices is therefore necessary to ensure the safety of the people using such devices.

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  • Licences are required for importing, exporting, manufacture, possession, use and sale of specified NIR apparatus.

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  • All NIR apparatus should be manufactured, designed, and labelled so that the requirements on shielding, interlocks and warning devices are met.

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  • Licences for medical diagnostic and surgical ultrasonic devices may be granted to qualified medical practitioners only.

Non-ionising radiation table and Classification of NIR.png

Transport of Radioactive Materials Regulations

  • Aims to provide a uniform and adequate level of safety which is suitable for the inherent hazard presented by the transportation of radioactive material by land, sea and air.

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  • Primary consideration is placed on:

  1. The safety features which are required to be built into the design of the package and requirements for testing the package design, thus minimising the need for any special actions during carriage

  2. Operational requirements for the implementation of, and compliance with the requirements of the Regulations for testing the package design, thus minimising the need for any special actions during carriage.

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  • Any conveyance used for the transport of consumer products to the point of retail sale to a member of the public as an end user must meet the applicable requirements of the Regulations.

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  • To minimise the possibility of radioactive material packages losing their containment integrity owing to the interaction of the package with other dangerous goods, they should be kept segregated from other dangerous cargo during transport or storage.

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  • The Regulations are not intended to be applied to movements of radioactive material that forms an integral part of a means of transport, such as depleted uranium counterweights or tritium exit signs used in aircraft.

Exemption for Transit, Transshipment and Carriage of Conveyance Equipment Regulations

  • Exempts consignors from licensing requirements stipulated in the Radiation Protection Act for radioactive material and irradiating apparatus (excluding nuclear material) that are transited or transshipped through Singapore.

Radiation Licencing Fees.png

  • *N2 licence no longer required for industrial ultrasound apparatus with power output less than 1,200W

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  • *Removal of requirement for N3 licence for medical and dentistry professionals if they have obtained the consent of the following persons to use a medical laser at a healthcare institution as per mentioned below:

  1. The individual in charge of that healthcare institution

  2. The licensee of the N2 licence granted in respect of that medical laser.

Medical Usage

  • Sufficient space available

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  • Thickness of walls and doors to provide protection

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  • Control panel must be outside with red lights on when radiation source is on

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  • Automatically terminate after preset time or dose

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  • Must be equipped with suitable radiation monitors or survey meters

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  • Radiation accident:

    1. non-medical application - unplanned, uncontrolled high level of radiation occurs

    2. medical application - therapeutic treatment is delivered to the wrong patient or to the wrong tissue of any patient; or if the patient is treated with a dose or dose fractionation which differs by more than 10 per cent from the value prescribed by the radiologist in charge of the treatment; or if the wrong radiopharmaceutical is used

Reference:

[1] National Environmental Agency (NEA)

Medical Devices/IVD SG
MANAGEMENT OF HAZARDOUS SUBSTANCES
Licensing controls prevent unauthorised persons from handling such substances and ensure proper safeguards are always taken in the handling of substances to prevent accidental releases and to mitigate ant adverse effects if they occur. 
Hazardous Substances Licence

Any person who wishes to import, sell, or export any hazardous substance controlled under the Environmental Protection and Management Act (EPMA) must obtain a licence.

Will be issued to a person if:

  • He can show proof that the hazardous substances will be stored safely in an approved location and in compliance with all storage requirements

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  • The use of the hazardous substances at his factory has been approved

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  • He has sat and passed the Management of Hazardous Substances Course

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  • His academic qualification must be at least a technical diploma.

Hazardous Substances Permit

Any person who wishes to import, sell, or export any hazardous substance controlled under the Environmental Protection and Management Act (EPMA) must obtain a Licence.

Will be issued to a person if:

  • He can show proof that the hazardous substances will be stored safely in an approved location and in compliance with all storage requirements

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  • The use of the hazardous substances at his factory has been approved

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  • He has sat and passed the Management of Hazardous Substances Course

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  • His academic qualification must be at least a technical diploma.

Transport Approval Control

Any person who wishes to transport any hazardous substance in quantities exceeding the limits specified in the Environmental Protection and Management (Hazardous Substances) Regulations must obtain a Transport Approval. The limits varies from 0 kg for highly toxic chemicals such as organochlorines pesticides to 1000 kg for corrosives such as sulphuric acid. Application for a transport approval shall be accompanied by a transportation emergency response plan (TERP) that has been prepared in accordance to SCDF’s format.  

Will be issued to a person if:

  • He holds a licence to handle hazardous substances

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  • He can show proof that the hazardous substances will be transported safely in compliance with all transportation requirements.

Environmental Protection and Management Act (EPMA)

The EPMA and its Regulations provide provisions for technical requirements to be imposed and complied with to ensure the safe management and handling of hazardous substances and to prevent an accident from occurring.

Storage requirement

  • Storage area should be sheltered; fenced-up; under lock and key; provided with kerb/hump all around the storage area; provided with fire protection and safety facilities; equipped with leak detection and warning devices and emergency scrubbing systems for storage of toxic gases.

  • Containers and storage tanks for the chemicals must be designed, manufactured and tested in accordance to an internationally-acceptable standards.

  • Keep records of stock movements of the hazardous substances.

  • Adequate emergency action plan (see Annex 1) for dealing with any accidental release of chemicals must be drawn; with adequate stock of emergency equipment such as neutralising agent, adsorbents, oversized drums, protective gears, etc kept on standby.

Transport requirement

  • The containers and tankers used for bulk chemical transportation must be designed, manufactured and tested in accordance to an internationally-acceptable standards. The tankers must be certified by an approved third party inspection body to have met the stipulated standards before it can be used for transportation on Singapore roads.

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  • Containers, tankers, and vehicles must be properly labelled and carry appropriate hazard warning panels.

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  • All transportation of controlled Hazardous Substances must strictly adhere to NEA's approved routes and must be between 9.00 am and 5.00 pm (Monday to Saturday excluding Sundays and Public Holidays)

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  • All drivers must be trained in the handling of accidental spills and have attended the HazMat Driver Course conducted by SCDF's Civil Defence Academy or Singapore Port Institute (PSA Institute).

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  • An adequate transportation emergency response plan (TERP) (see Annex 5) must also be put up to deal with any accidental release of the hazardous substances; with adequate stock of emergency equipment carried on the vehicles; such as chemical fire extinguisher, neutralising agent, adsorbents, oversized drums, protective gears, etc.

Emergency Response Plan

As a condition for granting licences and transport approvals, companies are required to put up emergency response plans.

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The plan must be comprehensive and should contain the following key elements:

  • Notification procedures; (persons and authorities to contact and how to contact)

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  • Emergency procedures to contain and decontaminate spills; (immediate actions to be taken by driver/ground staff and actions to be taken by the company upon being informed)

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  • Emergency equipment to be carried on the vehicle and at base such as personal protection equipment, absorbents, neutralising solutions and salvage drums

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  • Material Safety Data Sheets of the hazardous substances transported.

CONTROL OF VECTORS AND PESTICIDES ACT (CVPA)

  • All pesticide and repellent products intended for use against the five vectors (i.e. mosquitoes, flies, rodents, cockroaches and rat fleas) in Singapore are required to be registered with the National Environment Agency (NEA).

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  • The main objectives of this registration are to ensure that the pesticide and repellent products sold in Singapore are:

    1. Effective for their intended use

    2. Unlikely to pose undue hazards to the public and the environment​

    3. Properly labelled

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  • It is the responsibility of the dealer to ensure the safety, efficacy, and quality of the product.

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  • A Hazardous Substances Licence/Permit issued by the Development Control & Licensing Division (National Environment Agency) is required, prior to registration, for pesticides or repellents containing any hazardous substance controlled under the Environmental Protection and Management Act (EPMA).

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  • Pesticide and repellent products are registered under the following categories:

    1. For General Use: can be used by households directly. The formulated product should be “Unlikely to present acute hazard in normal use” (based on the “WHO Recommended Classification of Pesticides by Hazard and Guidelines to Classification 2009”).

    2. For Restricted Use: shall only be handled by licensed pest control operators. The formulated product may have high toxicity or concentration, and/or require further mixing/dilution and/or specialised equipment for the application of the product. All rodenticide products are required to be registered as “For Restricted Use”.​

  • Pesticide and repellent products can be further classified based on type of active ingredients into chemical, microbial, or botanical products, based on the type of active ingredients.

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  • Pesticide and repellent products, unless specifically required by NEA, are not subjected to registration with NEA prior to advertising, sale or supply of the products:

    1. Fumigants, which are controlled under the Hydrogen Cyanide (Fumigation) Act;

    2. Pesticides/repellents imported solely for re-export purpose;

    3. Pesticides/repellents solely for agricultural and/ or for gardening use (please seek advice from the SFA (Singapore Food Agency) on the registration of agricultural pesticides);

    4. Pesticides/repellents that do not target the five mentioned vectors (i.e. mosquitoes, flies, rodents, cockroaches and rat fleas);

    5. Pesticides/repellents whose mode of action is physical in nature (e.g. light and ultrasound);

    6. Repellents formulated with botanical active ingredients.​

Reference:

[1] NEA

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