E-cigarette compliance requirements in Malaysia

Background:

On March 31, 2022, The Minister of Domestic Trade and Consumer Affairs of Malaysia has issued an executive description (Certification and Marking of its Descriptions) Electronic Cigarette Device) Order 2022, which will take effect on August 3, 2022.

Noun explanation:

Refer to Malaysia Standard MS 2716 - electronic cigarette device - Safety requirements and te for the definition of "Electronic cigarette device"

Competent authority:

SIRIM QAS International Sdn.Bhd. (hereinafter referred to as SIRIM QAS) shall issue manufacturing labels for electronic atomizer equipment and components conforming to MS 2716.

Implementation requirements:

Anyone supplying electronic atomizer equipment and components to the Malaysian market must first apply for a certificate and label from the SIRIM QAS and display the label on the product or package.

Illegal punishment:

Any failure to comply with this order is an offence punishable upon conviction by the following penalties:

If the person is a body corporate, the penalty is not more than RM200,000; For a second or subsequent offence, a fine not exceeding RM500,000 is imposed;

If the person is not a body corporate, the penalty is a fine not exceeding RM100,000 or a jail term not exceeding three years or both; For a second or subsequent offence, it will be subject to a sentence of imprisonment not exceeding five years or both. Full project test (MS 2716) :

Electrical Test: Electrical test:

Risk associated with structural integrity:

1. Drop Test: Recharge after drop test, External short circuit test

2. Risk of burns

3. Malfunction of ECU

4. Incompatibility of accessories

Mechanical Test: Mechanical test:

1. Risk associated with filling

2. Risk of injury

3. Risk associated with sealing

4. Vibration test

5. Shock test

Chemical Test: Chemical test:

The mouthpiece should be food grade compliance

EMC Test: EMC Test:

1. Radiation Emission

2. Electrostatic Discharge test

3. RF Field Strength Susceptibility

4. Magnetic Field Immunity

Wireless Connectivity Test(This test is not required if the product does not have wireless functionality):

Applicable for devices that have Bluetooth, WIFI or any communication module

Functional Test: Functional test:

All function stated on the brochure should be working as declared, All function stated on the brochure should be working as declared,

Batteries must comply with MS IEC 62133:2017;

USB charging ports shall comply with MS IEC 60950-1

The authentication program has two modes: Type 1b and Type 5.

Type 1b is a single certification mode, the applicant is a trader, each batch of goods need to be inspected, do not need factory audit, only approved label, no certificate;

Type 5 is a complete product certification mode. The applicant is the manufacturer, and the factory audit needs to be arranged every year to maintain the validity of the product certificate. The approval label is issued simultaneously

Type 1b certification procedure:

1. Application submitted by the importer: application form + full project test report + BL + invoice and packing list

2. Document evaluation: Evaluate the test report and all the materials submitted

3. Product Arrival: The product arrives in Malaysia

4. Sampling/inspection: SIRIM QAS for consignment sampling and inspection

5. Validation test/evaluation: partial project test, confirmatory test/partial critical test to ensure that the imported product is the same as the product declared in the full type test report

6. Recommend/approve

7. SIRIM QAS will issue a label based on the quantity of imported products. The applicant will purchase the label, which will be affixed to the minimum package or product of the product, as shown below

Type 5 Certification program:

1. Submit application form + full project test report + BL + invoice and packing list

2. Document evaluation: Evaluate the test report and all the materials submitted

3. Factory audit: Factory audit on production site, including adequacy of QC plan, calibration of test equipment, record keeping system and safety routine testing

4. Certification and approval procedures

5. Certification Panel evaluation: Preparation and recommendation of certification report to certification panel

6. Issue certificates

7. SIRIM QAS issue labels according to the number of applications, and issue labels of up to 3 months 'production capacity at a time. The applicant buys SIRIM labels, and the labels need to be pasted or affixed to the products, as shown in the figure below

8. Annual supervision and audit/market supervision

Certificate sample:

Cycle cost:

Numbers 6-7 apply to Type 1b mode. Serial number 1-6 Applies to Type 5 mode.

Other:

1. Contents of factory audit:

1. Quality control of components and incoming materials: All major raw materials that have a direct impact on product performance shall be subject to incoming inspection before acceptance and/or production. Manufacturer should

Identify, perform and record tests and compare results with material specifications for acceptance. Incoming raw materials shall be reported for analysis Certificate (CoA)/batch/lot test

And inspection records received by the manufacturer.

(i) Atomizer (including atomizer base (including heating coil), atomizer and cigarette holder)

(ii) The battery shall be certified by MS IEC 62133:2017

(iii) Charging ports, such as USB, Type C shall comply with MS IEC 60950-1

(iv) Chargers/adapters shall comply with MS IEC 60950-1 / IEC 62381

2. Process/Line quality Control: The Applicant shall ensure that adequate process control is implemented at the plant. The manufacturer shall determine the control of the intermediate process to ensure that expectations are met

Production process (depending on design) :

(i) Product assembly process: visual inspection and display function

(ii) Assembly process of atomizer: visual measurement and heating coil resistance

(iii) Battery circuit assembly process: visual inspection, routine test

The following is the 100% minimum routine testing required on the production line to cover the safety aspects of the product. Test on production line and witness during audit.

Functional testing should cover but not be limited to:

(i) On and off system

(ii) Automatic cut-off system

(iii) Automatic shutdown

(iv) Prevent overcharging

3. Routine testing

4. Disposal of nonconforming products

5. Final inspection before shipment: The applicant shall ensure that final inspection is carried out. Minimum final inspection tests shall include functional tests but shall not be limited to the same as regular tests:

(i) Appearance inspection

(ii) Functional test (on-off system, automatic shutdown system, automatic shutdown, anti-overcharge)

The minimum frequency of testing depends on the manufacturer's quality management system.

6. Equipment calibration: At least a caliper and multimeter should be available and calibrated

7. Record maintenance

2. Identification, packaging and labeling

1. Contents of product identification:

a. Name, trademark or other information identifying the manufacturer or supplier

b. Voltage (V), capacity (mAh), power (W)

c. Standard number and year

d. The SIRIM label is attached to the product or minimum package

2. Contents to be marked on packaging:

a. Name, trademark or other information identifying the manufacturer or supplier

b. Standard number and year

c. SIRIM authentication identifier (as shown in the following figure). The certificate number must be the same as the product certificate (only type 5 mode is supported).

3. Authentication marking method

a. Laser printing or embossing on the product

b. Printed on each package

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