Orthodontic Product Sold via Online Marketplaces in Malaysia
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Malaysian Dental Journal
Vol 1/2021
MALAYSIAN DENTAL JOURNAL
Orthodontic Product Sold via Online
Marketplaces in Malaysia
Al Imran Shahrul Naing1, Aida Nur Ashikin Abd Rahman1
1
Centre of Paediatric Dentistry & Orthodontics Faculty of Dentistry, Universiti Teknologi
MARA
__________________________________________________________________________________________
ABSTRACT
There has been an increasing number of online marketplaces (OMs) that provide a
platform for third-party sellers to advertise and sell their orthodontic products. There
are certain risks involved with this practice, and this article will discuss the risks of
marketing and selling orthodontic products via OMs to both dentists and the public,
and Malaysian regulation of locally sold orthodontic products.
Keyword: Orthodontics; Online; Marketplaces; Products; Malaysia
INTRODUCTION
Across the globe, the popularity of online shopping has increased drastically in
recent years, and there has been a proliferation of online marketplaces (OMs). More
specifically, there has been an increasing number of dentists purchasing their dental
products via online marketplaces (1,2). In OMs, sellers list their orthodontic products,
and the OMs process their transactions (3). The OMs do not own the products sold.
OMs allow smaller sellers to advertise and sell their products without the initial high
costs of opening a store.
Orthodontic products sold in Malaysia are tightly regulated by the authorities
(4). This is done to ensure that any orthodontic products imported and sold locally is
safe and meets international standards. On the other hand, OMs provide a platform
for sellers to avoid such requirements prior to selling these items in Malaysia.
However, this mode of purchasing orthodontic products can harm both dentists and
the public (5–9).
This article describes the regulations for orthodontic products sold in Malaysia,
specifically discussing orthodontic products sold in OMs, the risks of marketing and
selling orthodontic products via OMs to both dentist and the public.
Malaysian regulation of locally sold orthodontic products
For an orthodontic product to be imported into Malaysia, it must be registered
according to the requirements of the Malaysian Device Act 2012 (Act 737). The
regulation of orthodontic products is under the authority of Malaysia Medical Device
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Vol 1/2021
Authority (MDA), which is obligated to implement and enforce the Act 737 (10). The
individuals responsible for registering orthodontic products under Act 737 are the
manufacturers or, in the case of foreign manufacturers, the authorized local
representatives. These representatives must be licensed and domiciled in Malaysia.
The authorized representatives then appoint registered distributors to sell the
products.
There are several steps before a product can be sold in Malaysia (11). The
first step is to determine whether the product is a medical device. The term ‘medical
device’ covers any product used in health care for the diagnosis, prevention,
monitoring or treatment of an illness or a handicap but excludes drugs. According to
the MDA, an ‘orthodontic appliance’ is a dental device designed to influence the
shape and/or function of the stomatognathic system through the application of
physical force. Thus, orthodontic devices fit the definition of medical devices (12).
The next step is to group and classify the products based on the risks
associated with the vulnerability of the human body, the technical design, and the
manufacture of the devices. The third step is to conduct a conformity assessment to
collect evidence of conformity. To be as independent as possible, the product is then
verified by a conformity assessment body. The last step is to register the product
using MeDC@St. MeDC@St is a web based online application system for
registration of medical device and establishment licensing. The obligation of the
authorized representative is not limited to the registration of the product (13). The
authorized representative should ensure compliance with the requirements of good
distribution, cleanliness and suitability of premises, storage and stock handling,
traceability, product complaints, and so forth.
Orthodontic products sold in online marketplaces
Due to the increased popularity of online shopping, there have been
increasing numbers of orthodontic products sold via OMs such as eBay and Amazon
(14). In Malaysia, the OMs that are gaining popularity are Shopee and Lazada. The
orthodontic products listed in OMs are typically sold by third-party sellers who are
unregistered or unauthorized local distributors (6). By purchasing an item via OMs, a
dentist is bypassing the traditional distribution model, in which large manufacturers
sell their products to authorized local distributors or dealers, who then resell these
products directly to dentists (1,15).
The third-party sellers in OMs are commonly located abroad (14), and they are
required to register with the OMs prior to listing their items (16). According to
Malaysian regulation, foreign manufacturers are not permitted to sell their items in
Malaysia if they do not have local representatives or registration. Thus, the OMs
system allows them to bypass the MDA registration process.
Due to third-party sellers being located abroad, dentists will often not meet
sellers face-to-face, since all communications are done via the online communication.
There will be no demonstration of the products; instead, all information will be
described on the product pages. The products are then delivered to dentists via a
courier. In the traditional model, the distributor will typically meet the dentist in person
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to demonstrate the product. If the dentist is interested in purchasing the product, the
distributor will then order the product from the manufacturer and personally deliver it.
By using OMs, a third-party seller can sell orthodontic products to a larger
consumer base not limited to dentists. In this way, anyone with an account in the
OMs can purchase an orthodontic product without any proper background check by
the seller. Examples of orthodontic products that can be purchased in OMs are
orthodontic brackets, dental adhesives and acid etchant, light-curing units,
orthodontic archwire, elastomeric rings, and cross-elastics.
An orthodontic product sold on OMs is typically cheaper than one from a local
authorized distributor (14,17). Lower cost is one of the reasons that motivates
dentists to make OMs purchases. The prices are lower due to two main reasons.
Firstly, the items sold on OMs are not subject to duties or taxes by their import
countries. Secondly, the lower price may reflect the lower quality of the material itself
(6). Certain items sold in OMs are claimed to be manufactured, packaged and
labelled according to both international and local standards. However, without proper
registration with the MDA, there is no way to verify the claims made in OMs.
DISCUSSION
There are several major issues involved in purchasing orthodontic products
via OMs. The first issue is when a third-party seller is not registered with the MDA.
According to ACT 737, any orthodontic product sold locally should have been
registered with a local representative who will then be responsible for the product.
This is significant because if any harm were to arise from a product sold to a dentist,
the dentist would not be liable (18). However, if a product were knowingly purchased
from an unauthorized distributor, the dentist would be held accountable for any
adverse or harmful effects encountered by a patient – that is, the dentist would be
liable for negligence (15).
Secondly, certain orthodontic products require proper handling and storage,
such as bonding agent, which require refrigeration. Items purchased from OMs are
shipped using a courier service. Items are generally packaged like any other
household item purchased online. Without proper packaging and handling
requirements for certain items from the courier, items will undoubtedly be shipped in
substandard conditions. In addition, there are no guarantees that an item is free from
contamination during the manufacturing or handling of the item (19). Local authorised
distributors, on the other hand, are required by law to store and deliver the item as
required by the manufacturer (13). This is to ensure that the product is safe for use.
Thirdly, Malaysian law requires any orthodontic product to be properly labelled
(11). This labelling is essential for proper usage of items and for records. Items sold
on OMs are not labelled according to standard practice (5,14). The expiration dates
or lot numbers may not be provided. Expiration dates are important to determine
product lifespan. The lot number of an individual item is significant because it allows
authorities to take appropriate actions to trace and recall any defective devices.
In addition, orthodontic products are designed to perform specific functions.
When purchasing any product, a dentist expects it to perform as specified by the
manufacturer. For example, an archwire is expected to be either stiff or flexible
108Malaysian Dental Journal
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according to the wire type or dimension, and an elastomeric material is expected to
deliver a certain force when stretched. By purchasing a product through OMs, there
is no guarantee the item performs as expected (5,6,8,14). The increased time and
cost to correct any adverse outcome caused by a product might outweigh any cost
saving from purchasing the item from OMs.
Another issue pertaining to OMs is regarding the availability of medical
devices to be purchased by the public. Fake dentists offering orthodontic treatment
have become a major problem in Malaysia (9,20). These fake dentists offer
orthodontic treatments at a cheaper price without proper qualifications and typically
offer them in non-clinical settings (7). Generally, these fake dentists purchase their
materials from OMs. Authorised distributors are required to obtain buyers’ information
and places of practice prior to selling items to them. This is essential to prevent
products from being sold to unauthorized individuals. On the other hand, OMs do not
require background checks. Instead, buying orthodontic products in OMs is as simple
as clicking the ‘buy’ button.
A concern pertaining to the public is the ability of the public to perform do-it-
yourself orthodontics (7,9). By simply watching YouTube videos and purchasing
items through OMs, certain individuals believe they can conduct such procedures
themselves. For instance, the authors have seen increasing numbers of patients
coming into the clinic for the removal of self-administered brackets or composite
remnants of debonded brackets. Beyond self-orthodontics, a number of orthodontic
patients purchase orthodontic auxiliaries in between visits through OMs due to the
cheaper price and the ease of purchasing them compared with visiting their
orthodontists for replacements.
Information on products sold in OMs is typically provided by the sellers.
However, the information advertised there is often not supported with current best
evidence (21). Certain appliances sold there make unrealistic claims that they can
easily straighten one’s teeth. For any dental professional, it is obvious that such
sellers are giving false information regarding these products. However, the general
public without any dental knowledge might be persuaded to purchase such an item.
Unknowingly, these consumers might expose themselves to appliances that may
harm them.
Therefore, actions should be taken to regulate orthodontic products sold on
OMs (7), despite existing restrictions on selling dental devices (16). Based on the
numbers of orthodontic products sold on OMs, however, these restrictions do not
seem to work. Certain orthodontic products, such as elastomeric material, can be
mistaken by regulators as simple rubber bands. To stop this issue from becoming
worse over time, new steps must be implemented.
The first step is to increase dentists’ awareness of the risks of purchasing via
OMs, so that they use orthodontic products only from authorized distributors
(14,15,19). To determine if a seller is registered locally, dentists can search for the
name of the distributor or representative in the MDA website. The MDA has provided
an excellent platform for doing this and is very responsive to inquiries. If a dentist has
any doubt regarding a seller or product, they should communicate with the MDA prior
to making any purchase.
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Dentists have been taught to rely on evidence-based dentistry (EBD), and
should apply EBD in their decisions to purchase any orthodontic products (21,22).
Any product that makes claims of safety and conformity without any clear evidence
should raise a red flag, and dentists should refrain from purchasing such an item.
OMs sell large numbers of different products online, so they might not have enough
manpower to track every item sold. Thus, dentists have an obligation to report these
items to the OMs or to the local authorities (19).
There have been reports overseas on deaths related to fake braces due to
adverse reactions toward the materials (9). Therefore, the dental community has an
obligation to increase public awareness of the dangers of purchasing orthodontic
products from OMs. The public should discuss any claim made by any online seller
regarding any product with their dentist.
CONCLUSION
Orthodontic products sold via OMs risk being defective, expired, improperly
labelled, poorly packed, poorly shipped, contaminated or underperforming. Dentists
should not be tempted by the cheaper prices and should resist purchasing
orthodontic materials from OMs. To stop this growing trend, regulatory agencies
should enforce policies governing the purchase of dental products from OMs to
ensure that professional items sold for dental care meet regulatory standards and are
restricted to licensed dentists and/or registered dental practices. Furthermore,
national dental bodies should increase the awareness of dentists regarding the
danger of purchasing orthodontic materials through OMs. In addition, the public
should be warned about the harms of purchasing orthodontic materials themselves
via OMs.
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