Malaysia

Type A

Type C

Type G

Type M

Regulatory agency

• The Energy Commission, Suruhanjaya Tenaga (ST)

Regulations

• The Electrical Supply Act 1990 and Electrical Regulation 1994 require manufacturers to apply for Certificate of Approval (COA) and affix the product with the SIRIM Label or certification mark.
• Standards accepted by ST:
• Test report with or equivalent to Malaysia Standards (MS) issued by a DSM recognised laboratory. 
• CB test report and certificate. 
• Reports by laboratories that are accredited by DSM, ILAC, APLAC, etc.
• Guideline on test report validity of electrical equipment based on risk of electrical equipment identified by the Energy Commission.
• When applying CoA, for high risk equipment, the origin test report shall be valid for not less than 1 year and not exceeding 5 years from the date of test report.
• When applying CoA, for low risk equipment, validity of test report exceeding 5 years is acceptable.

Guidelines 

• Application must be made by the local importer.
• Manufacturers should obtain COA from ST before applying for SIRIM Label or certification mark.
• The SIRIM Label can be obtained through the SIRIM Product Certification Scheme (PCS) or Batch Testing Scheme (BTS).

Applicable product categories

• Product categories requiring SIRIM Label include: 
• Circuit breakers
• Domestic power tools
• Household appliances
• Lighting
• Plug tops/Plugs
• Socket outlets
• Switches and dimmers
• Wires/Cables/Cords
• Etc.

A full list of product categories may be found here. To determine if a particular product is subject to the above regulations, please contact us.

Our services at a glance

As a listed testing laboratory for Malaysia under the ASEAN EE MOU, TÜV SÜD’s test reports are accepted by ST for safety approval.

Regulatory agency

• The Energy Commission, Suruhanjaya Tenaga (ST)

Regulations

• Fiscal incentives have been introduced by the government for efficient electrical equipment and insulation material. 
• Minimum Energy Performance Standards (MEPS) are required for certain products. 

• The Energy Labelling Program is applicable and voluntary to certain products.

Guidelines

• Applications should be made to ST. 
• Performance testing, where applicable, should be done by SIRIM QAS International or any laboratory recognised by Standard Malaysia. 
• All manufacturers and importers of the following products must affix the energy efficiency label onto the products before they can be sold to customers namely for
• Air conditioners
• Domestic fans
• Lamps
• Refrigerators
• Television sets
• Washing machine (after 1 September 2018)

Applicable product categories

• A full list of product categories may be found here. To determine if a particular product is subject to the above regulations, please contact us.

Our services at a glance

• TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Malaysia requirements and obtaining the necessary approval. We are able to support you in meeting Malaysia's energy efficiency requirements and our test reports are well accepted globally.

Regulatory agencY

• Medical Devices Bureau (MDB), Ministry of Health

Regulations

• All medical devices to be placed in Malaysian market are required to be registered under Act 737. 
• It is a mandatory requirement stated by law for establishments to obtain establishment licences to conduct activities related to medical devices. 
• The definition of medical device is in accordance with the global harmonised (GHTF). 
• Medical devices are grouped into four classes with Class A posing the lowest risk, Class B with low to moderate risk, Class C with moderate to high risk and Class D with the highest risk.

Guidelines

• A Local Authorised Representative (LAR) is required. 

REGISTRATION PROCEDURE

• Classify and group the medical device. 
• Submit application form through the “MeDC@St” system*. 
• Appoint a CAB to conduct conformity assessment. 
• Apply for registration. 
• Labelling of medical device.

* MeDC@St is a web-based Online Application System for Establishment Licensing, Medical Device Registration

Applicable product categories

• The scope of this Guideline covers all medical devices to be registered under Act 737. To determine if a particular product is subject to the above regulations, please contact us.

Our services at a glance

• TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Malaysian requirements and obtaining the necessary approval. 
  
   

Regulatory agency

• Malaysian Communications and Multimedia Commission (MCMC)

Regulations

• Type approval is required for fixed line and wireless telecommunications products. 
• SIRIM QAS International is the designated CB. 
• Products must be marked with Self-labeling.
• EMC compliance is required for the above, where applicable.

Guidelines

• Application must be made by the local importer. 
• Two samples are required for physical inspection. Upon approval, products should be labelled with the SIRIM Label accordingly.

Applicable product categories

• Regulated telecom equipment include:
• Analogue Calling Line Identity Presentation (ACLIP) facility for connection to PSTN 
• Asymmetric Digital Subscriber Line (ADSL) transceivers 
• Connecting to the Integrated Services Digital Network (ISDN) using basic access 
• Connecting to the ISDN using primary rate access 
• Cordless telephone systems
• Low frequency cables and wires with PVC insulation and PVC sheath
• Overvoltage protective devices 
• Private Automatic Branch Exchange (PABX) system for connection to PSTN 
• Terminal equipment for Connecting to Public Switch Telephone Network (PSTN)
• Regulated wireless equipment include: 
• Amateur radio equipment 
• GSM mobile terminals 
• Land mobile radio equipment 
• Broadband Wireless Access (BWA) Equipment 
• IMT-2000 Third-Generation (3G) cellular mobile terminals 
• Short Range Devices (SRD) 

To determine if a particular product is subject to the above regulations, please contact us.

Our services at a glance

• TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Malaysian requirements and obtaining the necessary approval.