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Product regulation and testing in Malaysia

Find out about how the UK’s trade agreements can make it easier to export by removing regulatory barriers to trade in Malaysia.

Trade agreements with Malaysia

The UK has joined the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP), a trade agreement including 12 countries (Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, Vietnam and the UK), which entered into force between the UK and Malaysia on 15 December 2024. This means the UK and Malaysia have a free trade agreement for the first time.


CPTPP entry into force and ratification

As of 24 December 2024, CPTPP is in force between the UK and:

  • Australia
  • Brunei
  • Chile
  • Japan
  • Malaysia
  • New Zealand
  • Peru
  • Singapore
  • Vietnam

This means that the UK can access CPTPP provisions with said countries.

The following countries have not yet ratified the terms of the UK’s accession:

Canada and Mexico.

This means that the UK cannot yet access CPTPP provisions with those countries.

This guidance will be updated following each of the remaining countries’ ratification of the terms of the UK’s accession to CPTPP and will include when CPTPP will enter in force between the UK and the relevant remaining country.


This guidance explains how the UK’s membership of CPTPP can make it easier to export goods by removing barriers to trade. The rules around regulations, technical standards and conformity assessment agreed between the UK and Malaysia can be found in CPTPP Chapter 8: Technical Barriers to Trade (please note that this link directs you to the New Zealand Foreign Affairs and Trade Ministry which is responsible for the CPTPP agreement text).

Products sold in Malaysia must meet Malaysian product regulation requirements, regardless of whether you are seeking to access preferential tariffs when exporting under CPTPP.

Making conformity assessment easier

CPTPP can make it easier for UK manufacturers to have their goods assessed against other CPTPP members’ regulations in the UK, prior to exporting, rather than having to send samples to each market to be tested there. This is because the agreement will allow UK Conformity Assessment Bodies to get accreditation to test against other countries regulations. This could reduce the time and costs compared to having conformity assessments take place overseas, which could especially benefit small and medium-sized enterprises (SMEs) for whom the costs of overseas testing can be prohibitively expensive.

You may even be able to use the same conformity assessment body to test against both UK and other CPTPP members’ regulations, provided that body has the right to test against both countries’ regulations. You will need to check with the individual conformity assessment body if they are able to test against another country's regulations.

If you do encounter any problems in conformity assessing goods for export to CPTPP markets, the UK now has the power to:

  • receive explanation of how any conformity assessment process works from another CPTPP member
  • receive explanation for any conformity assessment tests being declined in another members territory

You can contact the UK government via the support links with details of your situation to see if either of these provisions apply.

Your products will still need to meet the relevant regulations in each market you want to export to, and you will need to check whether the UK-based conformity assessment body is accredited to test against the relevant regulations of the market you want to export to, to ensure your products can be sold there.

Overview of product regulation and testing

To sell goods in another country, export products must meet the relevant regulations of that country. In trade agreements, we try to make this easier for your businesses by working with partner countries to agree principles for how they manage regulations standards and conformity assessment processes. This could mean anything from ensuring a country’s regulations are aligned to international standards, to setting out how a country should inform the WTO of regulatory changes, to agreeing that regulations in a specific sector should be equivalent to each other.

Trade agreements do not impact a country’s right to set its own regulations. They serve to make cooperation on regulations, and therefore trade between countries, easier.

The regulations a product will have to meet can define specific characteristics such as:

  • size
  • weight
  • ingredients
  • shape
  • design
  • labelling, marking and/or packaging
  • functionality
  • performance

For most goods that have technical regulations, businesses will need to test their products to prove that they meet the required regulatory rules before they can sell their goods. This testing is called conformity assessment. In the UK, the type of conformity assessment required for a product is dependent on the level of risk it poses to consumers.

  1. Low-risk products, such as certain types of clothing, do not need to undergo any formal conformity assessment procedures at all.
  2. For medium-risk products, like certain low risk personal protective equipment, manufacturers can ‘self-declare’ conformity with the relevant technical regulations, rather than requiring external bodies to do so.
  3. Higher-risk products, such as medical devices, require conformity assessments to be carried out by independent third-party organisations. This is referred to as “third-party conformity assessment”.

Once a product has passed the relevant conformity assessment requirements the manufacturer can use conformity assessment markings to show customs officials and consumers that the product meets the relevant requirements and is safe. The CE mark is the EU’s main conformity assessment mark, and the UKCA (UK Conformity Assessed) is the UK’s new mark. You can access information on using the UKCA and CE mark.

Most conformity assessment bodies are accredited by UKAS (the UK Accreditation Service) which is appointed by the UK government to assess and accredit conformity assessment bodies. The main exceptions are medical devices and pharmaceutical products, for which the Medicines and Healthcare Regulatory Authority is responsible for accreditation.

Certificates of free sale are not required by CPTPP countries. If a CPTPP country requests one, please contact the Department for Business and Trade via the Export Support Service for assistance.

Promoting harmonised regulation

Multiple countries having similar product regulation requirements makes it easier for manufacturers to make one version of a product and sell it in different markets, reducing manufacturing and testing costs. As a member of CPTPP, the UK can work with the other members to make regulations less restrictive and encourage countries to make their regulations more similar.

We encourage all businesses to engage with HMG if there are regulatory challenges they are experiencing with any CPTPP member state. Officials in the UK government can use the CPTPP engagement to raise these concerns, and to work towards greater regulatory cooperation.

The CPTPP agreement also includes sector-specific commitments for 7 sectors – including wine and distilled spirits, pharmaceuticals, and cosmetics. The annexes are designed to promote cooperation and facilitate trade in their given sector, and so businesses exporting in one or more of these sectors may want familiarise themselves with the CPTPP Chapter 8: technical barriers to trade annexes.

Malaysian product regulation 

Malaysia accepts a variety of conformity assessment marks as means of demonstrating products comply with Malaysian Standards, including the CE mark for medical devices.

Products in Malaysia must meet the relevant Malaysia Standards (MS). For more information on Malaysian Standards, see the Department of Standards Malaysia website.

Standards Malaysia is the National Accreditation Body of Malaysia, responsible for accrediting Conformity Assessment Bodies (CABs) to test against Malaysian product standards. UK CABs who apply for and receive accreditation from Standards Malaysia will be able to test against Malaysian regulations in the UK.

Definitions

Technical regulations

Mandatory requirements a product must meet to be sold in a market, for example what information must be included on labels for alcoholic beverages.

Standards

Voluntary requirements which can be an efficient way of demonstrating compliance with technical regulations.

Conformity assessment

Procedures by which products are assessed to show compliance with regulations or standards, including activities such as testing, inspection and certification.

Self-declaration of conformity

An approach which allows manufacturers, or an authorised representative of a manufacturer (where allowed by relevant legislation) to assess compliance with the relevant regulatory requirements without requiring third party conformity assessment. More information can be found on the conformity assessment and documentation guidance.

Conformity assessment body

Independent organisation responsible for conducting conformity assessment of products where the regulations require this to be done by an independent body.

Third-party conformity assessment

Product testing done by independent third-party conformity assessment bodies. Used for higher risk products such as electronics and construction materials.

To find conformity assessment bodies who are able to test your products against UK and other CPTPP countries’ regulations, search the ‘find a conformity assessment body’ service database or go to the UK Accreditation Service (UKAS) website for more information.

CPTPP Annex Summaries

This section summarises the key provisions from sector annexes under the CPTPP Technical Barriers to Trade Chapter. It is designed to help UK businesses understand the regulatory environment when exporting to or operating within CPTPP member markets. For full details and requirements from each sector annex, please do refer to the full legal text.

Devolved Governments and Crown Dependencies are covered by these annexes. These annexes do not apply to Northern Ireland.

Annex 8-A: Wine and Distilled Spirits

Laws and regulations on wine and distilled spirits must be publicly available.

Supplementary labels can be placed before sale. Multiple labels are allowed if they do not cover mandatory information, and required information does not have to appear in a single field of vision.

The following are not required on labels, containers or packaging:

  • translations of trademarks or trade names
  • production date
  • expiration date
  • date of minimum durability (minimum durability can only be requested for products with shorter shelf life)
  • sell by date
  • oenological practices (unless for health and safety reasons)

Alcoholic volume can be expressed up to 0.1 decimal point, e.g. 12.1%

Lot codes are permitted, though placement details are up to the supplier’s discretion, and CPTPP states can impose penalties for removing or deliberately defacing lot codes.

Only wine made exclusively from grapes frozen on the vine can be called ‘icewine’.

Quality and identity requirements should be based solely on minimum ethyl alcohol content, raw materials, added ingredients and production procedures.

Imported wine does not need certification in their origin country unless there are concerns about its origin, vintage or identity. Necessary certifications should consider Codex guidelines. Certification, test results or samples are required only with the initial shipment of a brand, producer and lot. Samples must not be larger than needed for conformity assessment.

New technical regulations, standards and conformity assessment procedures (CAPs) will not apply to products already on the market before entry into force as long as those products are sold within a period of time after entry into force and unless problems of human health and safety arise.

CPTPP members are encouraged to accept one another’s mechanisms for regulating oenological practices by assessing each other’s laws, regulations and requirements.

Annex 8-B: Information and Communications Technology Products

Outside government use, a CPTPP member cannot require a manufacturer or supplier to transfer or give access to a technology, process or other information. They also cannot require partnering with a person in its territory or using a particular cryptographic algorithm or cipher.

The supplier’s declaration of conformity will be accepted by CPTPP members.

This annex does not apply to law enforcement, networks owned or controlled by the state’s government (including banks) or measures related to financial institutions and markets.

Annex 8-C: Pharmaceuticals

Which products and regulatory agencies that fall under this annex must be made publicly available. Unnecessary duplication between agencies should be reduced.

CPTPP members should consider international scientific or technical guidance and improve alignment through international initiatives.

Marketing authorisation applications should be assessed within a reasonable period of time. Pricing, sale or financial data cannot be requested for these applications. Upon request, CPTPP members must explain if an application is not approved and there should be an appeal and review process. Products requiring periodic reauthorisation may remain on the market while waiting for a decision, unless there are health or safety concerns. Marketing authorisation from the origin country is not required ahead of receiving the product in the destination country.

Marketing authorisation applications must consider the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Technical Requirements for Registration of Pharmaceuticals for Human Use Common Technical Document.

Requirements that could lead to substantial delays in marketing authorisation or inhibit the effectiveness of procedures that ensure the safety, efficacy or manufacturing quality of the product should be minimised.

Inspections will follow internationally recognised scientific guidance, with Parties notifying each other in advance (unless doing so would reduce the inspection’s effectiveness). The inspecting party will allow the other Party’s competent authority to observe the inspection and will share findings as soon as possible. If the results are to be made public, the other Party must be informed within a reasonable timeframe before release.

Annex 8-D: Cosmetics

CPTPP members must publicly list which products fall under this annex and which agencies regulate them. Unnecessary duplication between agencies should be avoided.

Members are encouraged to collaborate through international initiatives and consider international scientific or technical guidance documents.

Marketing authorisation processes and decisions should be timely, reasonable, objective, transparent and impartial, without requiring prices or costs. Separate marketing authorisation processes or sub-processes for specific shades or fragrances are not allowed unless there are significant human health or safety concerns. Re-testing or re-evaluating product variants should be avoided unless there are significant human health or safety concerns. Rejections should be explained upon request, and an appeal or review process should be available. Periodic reassessment and Certificates of Free Sale cannot be required.

Marketing authorisation from the country of manufacture is not needed for approval in the destination country. CPTPP countries should consider replacing market authorisation processes with other mechanisms, such as voluntary or mandatory notification and post-market surveillance. Labels cannot require marketing authorisation or a notification number. Mandatory information can be added via relabelling and supplementary labelling before sale.

Requirements that could lead to substantial delays in marketing authorisation or inhibit the effectiveness of safety or manufacturing quality procedures should be minimised.

Testing cosmetics on animals cannot be required, but the results of animal testing can be accepted. Good manufacturing practice guidelines should use international standards unless it would be ineffective or inappropriate.

CPTPP countries should share their findings on cosmetic ingredients, and, subject to national laws and regulations, information from post-market surveillance.

Annex 8-E: Medical Devices

CPTPP countries must publicly list the products covered by this annex and the agencies that regulate them. Unnecessary duplication between agencies should be reduced.

Members are encouraged to collaborate through international initiatives and consider international scientific or technical guidance documents. Granting marketing authorisation should be based on clinical data covering safety efficacy; as well as performance, design, manufacture quality, other matters that can affect the health or safety of the user; and labelling information related to safety, efficacy and use of the device. Sale data, pricing and financial data must not be required for authorisation.

Marketing authorisation from the origin country is not needed to get it in the destination country. Marketing authorisation processes and decisions should be timely, reasonable, objective, transparent and impartial. If authorisation is denied, the reasons for doing so should be given, and appeal and review processes must be available. Products requiring reauthorisation can remain on the market during the decision process unless there is a significant health or safety concern. Medical devices should be regulated according to their risk level.

Relabelling and adding supplementary labels to meet requirements is permitted before sale.

Requirements that could lead to substantial delays in marketing authorisation or inhibit the effectiveness of procedures for ensuring the safety, efficacy or manufacturing quality of the product should be minimised.

Annex 8-F: Proprietary Formulas for Prepackaged Foods and Food Additives

This annex commits member countries to only ask for necessary information when gathering information relating to proprietary formulas and ensure the confidentiality of that information.

Annex 8-G: Organic Products

CPTPP members are encouraged to exchange information about organic production, product certification and related control systems.

Cooperation on international guidelines, standards and recommendations is promoted.

Members are encouraged to recognise the equivalence of regulations, standards or conformity assessment procedures (CAPs), technical exchanges are encouraged to support improvement and greater alignment.

If a request for equivalence is rejected, the rejecting party must provide an explanation upon request.

Department for Business and Trade support

The Department for Business and Trade (DBT) helps businesses export, drives inward and outward investment, negotiates market access and trade agreements, and champions free trade. Helpful links, tools and services available from DBT and wider government include:

Export Support Service (ESS) team

Get support on how to do business abroad. You may also be eligible for 1-2-1 support from a local International Trade Adviser. Businesses in Wales can also access support from Business Wales.

Export Support Service – International Markets (ESS-IM)

DBT's overseas in-market export support service for SMEs with high-export potential. Our International Market Advisers provide tailored support and market introduction information to new and current UK exporters looking to enter or expand into new markets. The service may be accessed globally with International Markets teams in South Asia, China, the Middle East, Africa, Eastern Europe, North America and Latin America.

UK Export Academy

Sign up to access free training on how to grow your international sales.

UK Export Finance

Information on finance and insurance for UK exports.

Trade and investment factsheets

The latest statistics on trade and investment between the UK and individual overseas partners.

Overseas business risk profiles

Information for UK businesses on political, economic and security risks when trading overseas.

Foreign travel advice

Advice and warnings about travel abroad, including entry requirements, safety and security, health risks and legal differences.

Check or report a trade barrier

If you encounter an issue when exporting to any country – report the issue and UK government officials will be able to assess the issue and consider the options we have open to addressing it as appropriate

Check how to export goods

Search for your specific product to find applicable tariffs for each market, explore rules of origin and step-by-step help on customs procedures

UK Integrated Online Tariff

Check import duties and allows you to check the status of available tariff rate quotas

Useful resources

You can find more information about export opportunities, business culture and any existing trade barriers on our Malaysia market guide.

Prior to export, you must be aware of local regulations and import conditions in Malaysia that apply to your goods or services. This can include tax considerations, labour laws, intellectual property rules, labelling and packaging regulations, among others.

To seek further information related to local regulations, business culture, or to find a local lawyer, translator, importer or distributor, you can use the following contacts:

To see information on political, economic and security risks when trading with Malaysia, please see:

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