In Malaysia, there are various product safety regulatory regimes for products such as medical devices, including medical instruments and even software-based medical devices, pharmaceutical products and personal protective equipment (PPE).  

Medical Devices

Medical devices, including medical instruments and software-based medical devices, are regulated by the Malaysian Medical Device Act 2012 (MDA). There are also various pieces of subsidiary legislation related thereto. The regulator charged with the governance of this space is the Medical Device Authority, which must act within the powers conferred on it under the Medical Device Authority Act 2012 (MDAA) and all related legislation. For the purposes of the MDA, “medical device” is defined as follows. 

• Any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article intended by the manufacturer to be used, alone or in combination, for human beings for the purpose of:
1. diagnosis, prevention, monitoring, treatment or alleviation of disease; 
2. diagnosis, monitoring, treatment, alleviation of or compensation for an injury; 
3. investigation, replacement or modification, or support of the anatomy or of a physiological process; 
4. supporting or sustaining life; 
5. control of conception; 
6. disinfection of a medical device; or 
7. providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body, which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its intended function by such means.
• Any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, to be used on the human body, which the Minister may, after taking into consideration issues of public safety, public health or public risk, declare to be a medical device by order published in the Gazette.

As readers will note, the ambit of this definition is extremely wide and a legal assessment of the device or instruments prior to dealing with them in Malaysia is encouraged. If the PPE in question is medical PPE, it is classified as a medical device and the related “medical device” legislation and regulations will apply to it too. 

Pharmaceuticals

There are various pieces of legislation in Malaysia enacted to regulate the pharmaceutical industry, amongst others, the Malaysian Sale of Drugs Act, 1952 (SDA) and its related regulations and the Malaysian Poisons Act, 1952 (PA) and its related regulations, including the Poisons Regulations, 1952 (PR). These regulatory frameworks seek to govern, amongst other aspects, activities and dealings (including importation, possession, manufacture, compounding, storage, transport, sale and/or use) involving substances and/or ingredients (including medicines and other similar pharmaceutical products either alone or containing such substances and/or ingredients) falling within the respective regulatory scope of the SDA, PA and PR. An understanding of the definitions accorded to the terms “drugs” and/or “poisons” as they appear in the SDA, PA and PPA will be helpful in understanding the requirements, restrictions and/or obligations that may be imposed on various stakeholders under these regulatory frameworks and is especially crucial in navigating any business operations or pharmaceutical products and/or service offerings in Malaysia, especially new ones. In addition to the SDA, PA and PPR, there are also regulatory constraints on certain advertising activities and/or the sale of medicines and pharmaceutical products, for example, the requirements under the Malaysian Medicines (Advertisement and Sale) Act 1956 (MASA). MASA contains prohibitions and restrictions affecting, among other things, the sale and/or advertising activities or advertorial paraphernalia relating to medicine.  

Cosmetics

In addition to the above, business stakeholders should also assess whether the product they deal with falls within the “cosmetic component” of the regulatory framework under the SDA, namely the Malaysian Control of Drugs and Cosmetics Regulations, 1984 (CDCR), which will apply to products falling within the definition of “cosmetics” thereunder. Cosmetics are defined in the CDCR as any substance or preparation intended to be placed in contact with the various external parts of the human body (including epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity, with an exclusive or main purpose of cleaning them, perfuming them, changing their appearance or correcting body odours, protecting them or keeping them in good condition.

The National Pharmaceutical Regulatory Agency (NPRA) issued the Guidelines for Control of Cosmetic Products in Malaysia and these need to be read together with other relevant pieces of legislation such as the PA, MASA, and others, which may apply due to the composition of the ingredients of the cosmetics and/or the nature of the product in question.

General Legislation

There are also pieces of legislation and regulations which are of a more general application, such as the Malaysian Private Healthcare Facilities and Services Act, 1998 (PHFSA) and its related regulations, which should also be borne in mind whilst operating a private healthcare facility or service offering, among other endeavours. While there is quite a labyrinth of legislation and regulations (including guidelines and polices from the Malaysian Ministry of Health) to navigate through, it is not too daunting a task to undertake, and all relevant business stakeholders should do so to better position their pharmaceutical business and products and/or service offerings, especially in pursuing new opportunities through digital platforms and the sophistication of technology.

Cosmetics

Please see 1.1 Medical Devices for more information and for the definition of “cosmetics”.

Biocides

The legislative framework in relation to biocide products is a little spread out in that there is no single piece of legislation dealing with “biocides”. However, Malaysia does have legislation such as the Malaysian Pesticides Act 1974 (the “Pesticides Act”) and its regulations, which regulate any substance that contains an active ingredient or any preparation, mixture or material that contains one or more of the active ingredients listed in the Pesticides Act as one of its constituents (this may include chemical components found in biocide products).

Food

For food, including nutritional supplements, Malaysia has the Malaysian Food Act, 1983 (the “Food Act”) and the Food Regulations 1985 (the “Food Regulations”) which contain requirements and restrictions with the intention of protecting the public against health hazards and fraud in the preparation, sale and use of food, and matters incidental thereto or connected therewith.

As far as the product safety regulatory regime for new products/healthcare offerings through technology and other digital modes, such as medical applications (apps) and wearables or even telemedicine offerings, are concerned; generally, products such as healthcare-related apps can, depending on their features and capabilities, be classified as medical devices under the MDA in light of the broad definition of medical device highlighted in 1.1 Medical Devices, and the compliance requirements under the MDA will have to be met in regard to such healthcare-related apps. In essence, the term “medical device” covers any product used in healthcare which falls within the definition in the MDA as stipulated in 1.1 Medical Devices.

Wearables

Wearables may be classified as medical devices depending on their nature and capabilities. Accordingly, the regulatory framework relating to medical devices as described in 1.1 Medical Devices may apply. Other than this, under the Personal Data Protection Act 2010 (PDPA), “sensitive personal data” includes any personal data consisting of information on the physical or mental health or condition of a data subject. Where any wearables collect health data, personal data protection law may therefore be applicable. Where such health data falls within the ambit of sensitive personal data, more stringent obligations may be imposed on a data user, including the requirement for explicit consent of the data subject.

Telemedicine

As far as telemedicine is concerned, while the Telemedicine Act 1997 (the “Telemedicine Act”) was passed by the Malaysian Parliament in 1996, it is still not yet in force. During the COVID-19 pandemic, the Malaysian Medical Council issued the Advisory on Virtual Consultations in relation to the treatment of patients via telemedicine, which remains a useful guide. Other than this, the Malaysian Ministry of Health has also introduced the Guidelines on the Online Sale/Supply of Medicines containing Poison by Licensed Pharmacists (Type A Retail Licence Holders) which set out the requirements for the sale/supply of medicines containing poisons online by a licensed pharmacist, among other things.

Medicines and Medical Devices

In relation to products that cross both components, for example a medical device which also dispenses medicine (namely a drug-medical device combination product (DMDCP) or a medical device-drug combination product (MDDCP)), the Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products states that the primary mode of action determines whether such combination products are classified as a DMDCP or an MDDCP. The regulatory authority that governs such combination products is also dependent on the primary mode of action of the DMDCP or the MDDCP. The primary mode of action of a DMDCP depends on the pharmacological, immunological or metabolic action in/on the body, and thus is regulated as a drug by the NPRA according to the requirements set forth in the CDCR, which is promulgated under the SDA, and any other relevant documents published by NPRA. On the contrary, for a MDDCP, if the primary mode of action in or on the human body is not based on pharmacological, immunological or metabolic means, but may be assisted in its intended function by such means, the MDDCP is regulated as a medical device by the Medical Device Authority according to the requirements set forth in the MDA and its subsidiary legislation and regulations, and under any other relevant guidance documents. However, in the case where manufacturers may not be entirely sure of their classification and the primary mode of action, a product classification application may be sent to the Medical Device Authority for consideration.

Personal Protective Equipment

As far as PPE is concerned, the Medical Device Guidance Document - Personal Protective Equipment (PPE) Requirements distinguishes PPE as either medical PPE or non-medical PPE. If the manufacturer’s labelling, advertising or documentation of the PPE indicates the intended use as the prevention of the transmission of disease and medical purposes such as surgical, clinical or use in other health services, then this would be classified as a medical PPE and is required to be registered with the Medical Device Authority. Non-medical PPE, such as that used in construction and other industrial applications, is not regulated by the Medical Device Authority.

Cosmetics, Biocides and Medicines

For borderline products specifically mixing cosmetics, biocides and/or medicines, there is uncertainty as to which regulatory framework takes precedence. The NPRA has issued guidelines in relation to medical device-drug-cosmetic interphase products, and the classification of products is based on the intended purpose of the product, the primary mode of action by which the claimed effect or purpose of the product is achieved, the active ingredient, indication and pharmaceutical dosage form (main criteria for classification of the drugs) and the classification of the products in the reference countries.

Food and Drugs

Turning lastly to food-drug-interphase (FDI) products, if the product contains ingredient(s) from a negative list for FDI issued by the NPRA, or has a medicinal/health claim, or is a product intended to be used, or capable, or purported or claimed to be capable, of being for a medicinal purpose, these products shall be regulated as a drug under the NPRA’s purview. Further, when there is an uncertainty in relation to the safety of an FDI product, such a product shall be regulated by the NPRA. On the contrary, FDI products that do not contain ingredient(s) from the negative list for FDI and do not have a medicinal/health claim shall be regulated as food under the Food Safety and Quality Division's purview.

Medical Devices

In the manufacturing processes, starting with the discussion on medical devices, one should note that a manufacturer’s obligations under the MDA include ensuring that a medical device (including a medical instrument) conforms to the prescribed essential principles of safety and performance, is manufactured in accordance with good manufacturing practice and any written directive issued by the Authority and is labelled, packaged and marked in accordance with the prescribed manner.

Manufacturers

Pursuant to the MDA, a “manufacturer” means the following.

• A person who is responsible for:
1. the design, production, fabrication, assembly, processing, packaging and labelling of a medical device whether or not it is the person, or a subcontractor acting on the person's behalf, who carries out these operations; and
2. assigning to the finished medical device, under their own name, its intended purpose and ensuring the finished product meets the regulatory requirement.

• Any other person who:
1. assembles, packages, processes, fully refurbishes, reprocesses or labels one or more ready-made medical devices; and
2. assigns to the ready-made medical device, under their own name, its intended purpose and ensuring the finished product meets the regulatory requirement.

“Manufacturer” does not include the following persons.

• Any person who assembles or adapts medical devices on the market that are intended for individual patients.
• Any person who assembles, packages or adapts medical devices in relation to which the assembling, packaging or adaptation does not change the purpose intended for the medical devices.

Manufacturers' obligations

The Medical Device Authority has also released a guidance document titled “The Essential Principles of Safety and Performance of Medical Devices”, requiring manufacturers to adhere to the following obligations, amongst others.

• Remove or reduce risk of injury to the user.
• Conform to safety principles, taking into account the generally acknowledged state of the art. The manufacturer should control or eliminate the risk and inform the users of any residual risks.
• Ensure that diagnostic devices are designed and manufactured in such a way as to provide sufficient accuracy, precision and stability for their intended use, based on appropriate scientific and technical methods.
• Ensure delivery of devices in adherence to the relevant transportation and storage conditions (sterile/protective packaging, if required) and appropriate labelling.
• Manufacturing and design should take into account any chemical, physical and biological properties and the device's compatibility with the human body, as well as any potential infections or microbial contaminations.

If the medical device is connected to or equipped with an energy source, ensure that it is designed to reduce any electromagnetic interference.

• Where the performance of devices depends on the use of calibrators and/or control materials, the traceability of values assigned to such calibrators and/or control materials should be assured through a quality management system.
• If the medical device is a piece of software, the software must be validated according to the state of the art, taking into account the principles of development life cycle, risk management, verification and validation.
• Provide protection against mechanical or thermal risks.

Common submission dossier template

In preparing the common submission dossier template for the Medical Device Authority, a manufacturer is required to outline the process; methods; procedure; environment; facilities; a list of various configurations of the medical device; a description of the key functional elements; an explanation of any novel features; and controls used for the manufacturing, processing, packaging, labelling and storage of the medical device. The manufacturer is also required to submit the instructions for use; warnings and precautions; a list of materials; alternative therapy; and other relevant specifications and descriptive information. If the device is a piece of software, reports and/or certification relating to the software must be produced. A manufacturer is also required to establish, maintain and implement quality management systems based on specified standards in respect of its manufacturing quality and processes. If multiple facilities are involved in the manufacture of the medical device, the applicable information for each facility must be submitted. 

Pharmaceuticals

In regard to pharmaceutical products, various requirements (including licensing requirements) and obligations are imposed on any person intending to manufacture, sell, supply, import, possess or administer such products under the related regulatory framework. As far as manufacturing obligations are concerned, a licensed manufacturer is required to establish a quality control department under the supervision of a suitably qualified person. A quality control department is obliged to control all materials used in the manufacturing process, monitor the quality aspects of all manufacturing steps and control the quality and stability of the finished registered products. The Drug Registration Guidance Document also provides for submission of a protocol of analysis, analytical method validation and product samples for laboratory testing for purposes of quality control, among other things. 

A licensed manufacturer shall ensure that all personnel employed at all levels of manufacturing possess suitable qualifications, have adequate experience, are technically competent, are regularly trained during their employment for the purposes of keeping up to date with any advances or changes and are medically examined regularly. Manufacturing premises shall be maintained in good and sanitary conditions, there shall be a sanitation programme for the maintenance of the premises in these conditions and records of the performance of the programme shall be kept. Manufacturing and testing equipment shall be designed, placed and maintained in such a way as to be suitable for their intended use. Manufacturers must facilitate thorough cleaning whenever necessary, minimise any contamination of registered products and their containers during manufacture and minimise the risks of confusion or omission of any manufacturing steps.

A licensed manufacturer shall ensure all weighing, measuring and recording equipment is maintained in good working conditions and is regularly calibrated. Where suitable, the manufacturer should have manufacturing steps monitored by recording devices, ensure all manufacturing equipment is thoroughly and regularly cleaned in accordance with such written specifications as the Drug Control Authority may determine and ensure records of such matters are kept and maintained. 

Good manufacturing practice

Licensed manufacturers are also required to conduct regular inspections of their manufacturing and quality control activities. Compliance with good manufacturing practice (GMP) and quality assurance programmes is also vital. A manufacturer shall maintain proper records of every batch of finished registered products that is distributed in order to enable the complete and rapid recall of the registered product if necessary.

PPE

As far as PPE is concerned, similar guidance as is outlined in 1.1 Medical Devices is applicable for PPE if it is classified as a medical device. The guidance document referred to in 1.4 Borderline Products outlines the minimum requirements/standards of the specification and design of the PPE, and the minimum performance and labelling requirements to be adhered to by the manufacturers of medical PPE to protect both the wearer and the patients in sterile environments.

Cosmetics

Cosmetic products must be manufactured in accordance to the Guidelines for Cosmetic Good Manufacturing Practice (CGMP). Amongst other requirements, the manufacturing sites should be suitably located, designed, constructed and maintained.  All sanitation and hygiene practices covering personnel, premises, equipment/apparatus, production materials and containers should be applied to avoid contamination during the manufacturing of cosmetic products. Amongst other requirements, the CGMP requires that manufacturing premises have adequate washing facilities for employees, well-ventilated toilet facilities separated from the production area and suitable locker facilities provided at an appropriate location. Manufacturers must also regulate collection of waste material outside the production area, and any rodenticides, insecticides, fumigating agents and sanitising materials must not contaminate equipment, raw materials, packaging materials, in-process materials or finished products. Further, all personnel directly involved in the manufacturing activities of the cosmetic products should be appropriately trained in manufacturing operations in accordance with CGMP principles. Special attention should be given to training of personnel working with any hazardous materials.

Biocides

In regard to biocides, if the biocide contains active ingredients as per the First Schedule of the Pesticides Act, the manufacturing entities are required to apply for a licence to manufacture the biocide. Only biocides that are of good quality, are effective for the intended purposes and do not cause unacceptable adverse effects on human beings, animals, plants, fruits or property would be approved by the Pesticides Board and registered in Malaysia. The Pesticides (Licensing for Manufacturing) Rules 2011 (PLMR) impose the following obligations on the holder of a licence.

• Supply appropriate personal protective clothing and equipment required to be worn by workers in the manufacturing of pesticides.
• Maintain or ensure the maintenance of all protective clothing and equipment in good working condition.
• Provide suitable cleaning facilities such as running water, soap, a sink and cemented floors to wash protective clothing and equipment.
• Provide a first-aid kit for workers.
• At all times, keep the unmanufactured or manufactured pesticides in a place that has been approved by an authorised officer (as defined in the PLMR).
• Provide for all workers involved in the manufacturing of pesticides a medical checkup at least once a year, the record of which shall be kept for five years and made available for inspection by any authorised officer, when required.

The Minister of Environment and Water is empowered under the Environment Quality Act 1974 (EQA) to regulate the manufacture, storage, transportation, or the application or use, emission, discharge, or deposit into the environment of any environmentally hazardous substances.

The EQA defines “environmentally hazardous substances” as any natural or artificial substances including any raw material, whether in a solid, semi-solid or liquid form, or in the form of a gas or vapour, or in a mixture of at least two of these substances, or any living organism intended for environmental protection, conservation and control activity, which can cause pollution. In the event that any environmentally hazardous substance is present in the specific medical device or healthcare product, and the environmentally hazardous substance does not fall within the ambit of the PA and the Pesticides Act, then the importer and/or the manufacturer is required to notify the Department of Environment of the environmentally hazardous substance via the MyEHS System.

Medical Devices

The Code of Advertisement (COA) published by the Medical Device Authority sets out the criteria to be fulfilled for approval to be granted in regard to any advertisement of a medical device (including medical instruments and PPE) falling within the purview of the MDA. Advertisements that contain certain matters, including the following, are prohibited:

• statements or visual presentations likely to mislead the consumer about any device;
• information which is exaggerated;
• therapeutic claims which assert or imply the ability to cure any ailment, illness or disease as listed in Annex E to the COA;
• claims that suggest or imply that a device will control, slow down or reverse the physiological processes associated with ageing or premature ageing;
• claims of improvement or enhancement of brain or memory functions or concentration;
• claims to provide immunity against specific diseases;
• use of a particular device to prevent or reduce the stress of modern living;
• claims that imply that the use of a particular device can improve performance in sports and studies;
• phrases such as “no side effects”, “no harmful effects”, and “no toxic or adverse effects”.

Advertisements shall contain information that is reliable, accurate, truthful, informative, fair, objective, unambiguous, balanced, up-to-date and capable of substantiation. The advertiser of a medical device should observe a high standard of social responsibility to consumers and to society, and they must meet the standards of morality and decency prevailing in Malaysian society.

Pharmaceuticals/Medicinal Products

As far as pharmaceutical products are concerned, the MASA and Guidelines for Advertising of Medicines and Medicinal Products to the General Public published by the Medicine Advertisements Board (MAB) set out the criteria to be fulfilled in regard to pharmaceutical advertisements.

Advertisements that contain claims referring to certain matters, including the following, are prohibited:

• the prevention, treatment, alleviation, cure or diagnosis of diseases and conditions as listed by MAB;
• contraception for humans;
• improving the condition or functioning of the human kidney or heart, or improving the sexual function or sexual performance of humans;
• procuring miscarriages.

An advertisement for medicinal products must present information that is factually correct and not exaggerated. Advertisements should take into account people’s legitimate desire for information, they must encourage the correct and proper use of medicine or a medicinal product and they should not be misleading. An advertisement shall be taken to be false or misleading if it falsely describes the medicine or medicinal product, or if it is likely to mislead consumers as to the nature or quality of the product or its uses or effects, or if it contains any reference to a false or misleading representation. 

Online advertising of medicinal products

In relation to online advertising of medicinal products, MAB has required that the approval number, name, address and contact number of the advertiser must be clearly displayed on every page which has been approved by MAB. In situations where medicinal products are advertised together with other health products, the advertiser must take precautions to distinguish the advertisements which have been approved by MAB from advertisements which do not require approval from MAB to avoid any misleading information.

Cosmetics

Cosmetics advertisements should only contain information that is reliable, accurate, truthful, informative, balanced, up-to-date, capable of substantiation and in good taste. They should not contain misleading or unverifiable statements or omissions likely to induce unjustifiable use or give rise to undue risks. The Guidelines for Control of Cosmetic Products in Malaysia list several examples of unacceptable claims including the use of symbols, logos or statements related to GMP certifications or standards and any reference to religion or religious statements. Further, cosmetics advertisements should not refer to any medicinal claims or claims that are beyond the scope of cosmetic products. They should not give any impression of providing professional advice or endorsements.

Medical Devices

In order to market medical devices legally in Malaysia, the registered company intending to sell medical devices (including medical instruments and PPE) which fall within the purview of the MDA needs to comply with the licensing and other requirements under the MDA related thereto.

The Good Distribution Practice for Medical Devices

For the purpose of marketing a medical device, the medical device must be registered and it must satisfy the following conformity assessment elements assessed by the Conformity Assessment Body. The Medical Device Authority also released the Good Distribution Practice for Medical Devices (GDPMD), which is applicable to all parties involved in the supply chain of medical devices including authorised representatives of foreign manufacturers, importers or distributors of medical devices in Malaysia. The GDPMD seeks to ensure the quality, safety and performance of the medical device throughout the medical device supply chain, which includes product sourcing and procurement; transportation and delivery; storage; installation; commissioning; service and maintenance; calibration and after sales service; tracking; documentation; and record-keeping practices. The GDPMD has established a compliance system which requires the relevant establishments to:

• maintain a regulatory compliance manual;
• define and delegate responsibilities to authorised designated persons;
• design resource management which includes training of personnel;
• provide secure and safe infrastructure and work environments; and
• establish clear communication channels to handle stock requirements, traceability and control of nonconforming medical devices.

Pharmaceuticals

There are stringent registration and licensing requirements under the CDCR for pharmaceutical products. Products listed under the CDCR must be further registered with the Drug Control Authority (DCA) through the NPRA. Additional licences are required for import or supply by wholesale of pharmaceutical products. An applicant is required to adhere to strict regulatory requirements. These requirements include:

• provision of an evaluation based on the product category;
• meeting bioequivalence and labelling requirements;
• ingredient checking;
• inclusion of the product name and educational material for active ingredients;
• ensuring that packaging is adjusted for each product;
• including a package insert for products containing scheduled poisons and injectable over-the-counter products; and
• providing a consumer medication information leaflet and product authentication.

The Guidelines on Good Distribution Practice are also applicable to the distribution of pharmaceutical products. The guideline provides standards for inspection of facilities, as well as management procedures for storage and distribution of registered products, quality systems, personnel management and transportation.

Cosmetics

The Guidelines for Safety Assessment of Cosmetic Products issued by the NPRA require cosmetic products to be safe for both consumers and professionals. They provide guidance in assessing the safety of products and outline the system for auditing the data contained in the product information file (PIF). In order to ensure the safety of cosmetic products, the following issues, amongst others, are taken into account.

• The application of the CGMP Guidelines.
• The careful selection of cosmetic ingredients, ensuring that they will be safe at a given concentration in a particular finished product.
• Checking the local tolerance of the finished product.
• Quality control and stability studies of the product.
• Adequate packaging and appropriate labelling of finished products.
• Adequate procedures and corrective actions in place in case of side effects of the marketed product.

The assessment of the safety of any cosmetic product clearly relates to the manner of use. As such, the main sources of information are the toxicological characteristics of ingredients and the available human experience (including market experience, beauticians, factory workers, etc) of products with similar compositions. If the new product is a simple variant of an existing product, or if the formulation only consists of raw materials or ingredients previously used in similar products at common use levels, then it is likely that no additional safety data will be needed. However, if raw materials are used in new ways, then additional safety data may be required by the safety assessor.

The main factors that influence the internationalisation plans for Malaysian manufacturers are the laws and regulations of the foreign import country where the manufacturers choose to export their products.

Some of the regulatory regimes listed in 1. Applicable Product Safety Regulatory Regimes control the export of certain medical devices and healthcare products. The relevant authorities control the quality, quantity and type of products by requiring exporters to obtain certain authorisations, approvals or licences to export products from Malaysia. 

The MDA provides for the post-market obligations. The Medical Device Authority has also released guidelines to expand on these obligations, such as the following.

• An establishment shall keep detailed records on the distribution process. The distribution records shall be retained for two years from the date on which the medical device was supplied or exported. Additional details are required for implantable medical devices, including details of the healthcare facility and the department conducting the implantation procedure, as well as the details of the patient in the procedure involving the implantable medical device. An establishment shall provide the distribution records to the Medical Device Authority upon request.

• An establishment is required to report to the Medical Device Authority any incidents relating to device failure or deterioration, or to inadequacy in its labelling or in its instructions, if it has led to the death of or serious damage to a user, or if it is a serious threat to public health that come to the establishment’s attention in regard to its medical device whether occurring inside or outside Malaysia.

• An establishment shall undertake corrective or preventive action in relation to a medical device imported and placed on the market. This may include return of the medical device to the establishment; modification, exchange or destruction of the medical device; or providing specific advice on the use of the medical device.
• An establishment may undertake a voluntary recall after it has notified the Medical Device Authority and all the persons that may be affected by the recall of the medical device within a certain period of time before the recall is made, based on the recall category. After the voluntary recall has been completed, the establishment shall submit a report to the Medical Device Authority. However, the Medical Device Authority may order an establishment to recall any medical device at any time in the interest of patient safety and public health. If ordered to do so, the establishment shall undertake the recall and must report the result of the recall within the period determined by the Medical Device Authority.

Pharmaceuticals

The NPRA has also released Malaysian Guidelines on Good Pharmacovigilance Practices (GVP) for product registration holders (PRH), which provides for the reporting of an adverse drug reaction (ADR) and adverse events following immunisation (AEFI) and safety updates. Specifically, the GVP deal with the responsibilities of the PRH, managing ADR/AEFI reporting, periodic benefit-risk evaluation reporting, structuring a risk management plan and preparation of a pharmacovigilance system summary and master file.

Cosmetics

There are post-market surveillance obligations for cosmetic products too. The NPRA monitors the compliance of cosmetic products through the post-market surveillance programme, consisting of activities including the screening of product formulation and information to ensure that cosmetics do not contain any prohibited or harmful substances and all restricted ingredients are used within the limits and conditions of use; sample collection and testing; monitoring of label compliance; auditing of premises for compliance with the CGMP; handling of product complaints; monitoring of advertisements and adverse reactions; auditing the PIF; risk communications and information sharing through the ASEAN Post Marketing Alert System. 

The CDCR specifies that a licensed manufacturer or manufacturer of the notified cosmetic shall maintain proper records of every batch of finished registered products or notified cosmetics distributed to enable the complete and rapid recall of the registered product or notified cosmetic if necessary. A notified cosmetic is a cosmetic product that has a cosmetic product notification issued by the NPRA prior to marketing, manufacturing or importing. Cosmetic notification holders are required to maintain a batch numbering system and the records of batch numbers for their finished products. Every finished product should bear a production identification number which enables the history of the product to be traced and the particular batch number should not be repeated for the same product in order to avoid confusion. Whenever possible, the batch number should be printed on the immediate and outer container of the product.

The CDCR provides also for certain reporting requirements relating to serious adverse reactions arising from the use of the registered product.

The regulatory authority governing medical devices (including medical instruments and medical PPE) is the Medical Device Authority. The regulatory authorities governing pharmaceuticals and cosmetic products are the DCA and the NPRA. Biocide products with an active ingredient listed in the First Schedule of the Pesticides Act are regulated by the Pesticides Board of the Department of Agriculture. Lastly, the regulatory authority governing food products is the Food Safety and Health Division of the Ministry of Health.

Medical Devices

The MDA has authorised the Medical Device Authority to act in relation to any medical devices (including medical instruments and PPE) registered under the MDA. The powers of the Medical Device Authority include the following.

• The power to impose additional conditions and to vary or revoke conditions, and to cancel the registration of a medical device.
• The power to impose additional conditions and to vary or revoke conditions in relation to the application of the establishment licence.
• The power to impose additional conditions and to vary or revoke conditions, suspend or revoke the permit.
• The power to investigate, search and seize with a warrant from the courts of Malaysia if there is a reasonable cause and be given access to computerised data and to direct anything seized to be sold and the proceeds of the sale to be held pending the result of any prosecution or claim, the power to arrest without warrant (and take the person to the nearest police station, if not arrested with a police officer).
• The power to demand, select, take or obtain samples of any medical device in the prescribed manner for the purposes of analysis.
• The power to grant and revoke confidentiality granted in whole or in part in the interest of public health.

Pharmaceuticals

The SDA has authorised the DCA to act in relation to any pharmaceuticals and cosmetic products registered under the SDA. The powers of the DCA include the following.

• The power to enter into and inspect any place where it has reason to believe that there is any drug intended for sale.
• The power to mark, seal, or otherwise secure, weigh, count or measure any drug the sale, preparation or manufacture of which is or appears to be contrary to the SDA, and to inspect any drug, wherever found, which it has reasonable grounds to believe is intended for sale.
• The power to demand, select and take samples for the purpose of analysis.
• The power to call for information if there are reasonable grounds for suspecting that any person is in possession of any drug or other substance for the purpose of sale, or of manufacturing or preparing drugs for sale in breach of the SDA.
• The power to require any person applying for the registration of any imported product to furnish a written declaration made by or on behalf of the manufacturer of the imported product that all requirements governing the manufacture of the product imposed by the law of the country of manufacture have been complied with.
• The power to, without assigning any reason, reject, suspend or cancel the registration of any product. It may amend the conditions of the product registration.
• The power of the licensing officer to authorise in writing any registered pharmacist in the public service to exercise the powers of a drug enforcement officer.
• The power to enter any premises and investigate the commission of any offence in relation to MASA.

Biocides

Biocide products that contain an active ingredient listed in the First Schedule of the Pesticides Act shall be regulated by the Pesticides Board of the Department of Agriculture. The powers of the Pesticides Board include the following.

• The power to register, refuse to register and cancel the registration of a product.
• The power to stop and examine a conveyance and seize any pesticide found therein in respect of which the contravention or offence is suspected to have been committed and any book or document that is reasonably believed to furnish evidence of the contravention or of the commission of the offence.

Food

The Food Act authorises any medical officer, any assistant environmental health officer of the Ministry of Health or of any local authority, or any suitably qualified person to act in relation to any food product registered under the Food Act. The powers of the authorised officer include the following.

• The power to demand, select and take or obtain samples of the food for the purpose of analysis.
• The power to obtain particulars of the composition and use of any substance to which the Food Act applies that is sold or offered for sale in the course of that business or used in the preparation of food.

Medical device and healthcare products are governed by the relevant statutory provisions relating to product safety. In respect of medical devices, the import, export or placement of unregistered medical devices is considered an offence. Further, the use or operation of medical devices on third parties which is unsafe and not in accordance with the intended registered purposes is also an offence. 

In respect of health products, the sale, supply, importation, possession or administration of a product which is not registered and/or notified according to the CDCR is an offence. The offences attract penalties of a fine, imprisonment or both. 

For example, in June 2022, a company was fined MYR10,000 for selling an unregistered medical product, which is an offence under Regulation 7(1)(a) and Regulation 30(1) CDCR.

Product liability claims in respect of medical devices and health products may be based on the tort of negligence, breach of statutory duty and/or breach of contract, amongst others. 

Whilst technology in medical devices and consumer health products is rapidly evolving, the laws and regulations governing product liability in Malaysia unfortunately remain unchanged.

Technological advancements have resulted in multiple stakeholders producing end products. Therefore, the assessment of a product liability claim in a medical device/health product with advanced technology may be more complex. Medical devices or health products may involve, for example, the use of software, the development of the software, the manufacturing of the product which uses the software and, ultimately, the use of the product. If and when a product liability issue arises, it becomes pertinent to identify the source of the defect in the chain of product development and, ultimately, the causes which then led to the injury and loss. An aggrieved party is therefore constrained to rely on traditional common law principles and existing regulations.

Courts in Malaysia have the jurisdiction to hear product liability claims, provided the claim satisfies Section 23 of the Courts of Judicature Act 1964. The jurisdictional requirements include that:

• the cause of action arises within the court’s jurisdiction;
• the defendant or one of several defendants resides or has a place of business within the court’s jurisdiction; or
• the facts of the case occurred or are alleged to have occurred within the court’s jurisdiction.

The award of costs is discretionary in nature and the Rules of Court 2012 will apply to any case brought in court.

Apart from pursuing a civil claim in the civil court, the Tribunal for Consumer Claims and the criminal court have jurisdiction to deal with product-related matters. Aggrieved parties may also commence judicial review against public authorities for decisions made by them. In Malaysia, judicial review is commonly commenced by parties aggrieved by a decision of the Tribunal for Consumer Claims. Inquiries may also be initiated. Product-related contentious matters, however, are usually pursued by the aggrieved party as a civil claim in court. 

In Malaysia, representative actions may be commenced in respect of injury due to medical devices and consumer healthcare products where parties with common interests and grievances may bring claims in the same proceedings. 

Parties in a representative action would have to seek relief(s) beneficial to all of them.

In the presence of a valid arbitration agreement, an aggrieved party may also bring a claim through arbitration. Mediation is also an option and can be undertaken privately between parties, or, if the matter is already in court, it may be conducted through the court’s mediation centre. 

Each liability mechanism has its own set of redress for the aggrieved party. However, the liability mechanisms are not mutually exclusive. Aggrieved parties have the liberty to commence civil claims, as well as lodge complaints or report to the relevant authorities in order for the public prosecutor to initiate a criminal suit.

As medical devices and consumer healthcare products are regulated by the relevant statutory provisions and regulations, there are product safety compliance rules that need to be respected. Non-compliance with such rules would attract product liability claims premised on, inter alia, breach of statutory duties. 

This firm is not aware of any policy developments or initiatives that exist in relation to product safety and liability of the products referred to in 1. Applicable Product Safety Regulatory Regimes.

The Poisons (Amendment) Bill 2022 (the “Bill”) has been tabled in the Malaysian Parliament and it aims to, amongst other things, regulate the use of electronic documents relating to the dispensation of drugs. The Bill recognises e-prescriptions as an acceptable form of prescription, subject to certain requirements.

Healthcare services which involve the use of medical devices and healthcare products have rapidly transitioned to digital and online tools to adapt to “the new normal” as a result of the COVID-19 pandemic. Given that there is no proper legislative framework on digital medical devices and healthcare products in Malaysia to date, the relevant enforcement bodies have been closely monitoring the available products on the market. For example, the Government of Malaysia launched the National Technology & Innovation Sandbox as a platform for product development which is in line with technological advancements.

Further, several criminal prosecutions have been initiated against parties involved in the sale of products which are deemed to be unsafe by the relevant authorities. In fact, several e-commerce and social media platforms that advertised unregistered products have also been flagged to be taken down.