Medical Devices Products Policy

If you sell medical devices and accessories on the SHOPLAZZA platform, you are required to comply with the applicable laws and regulations for your business. These laws and regulations depend on the location of your store and the regions where your products are sold.

You are responsible for reviewing and using this information appropriately. This content is not intended to provide legal advice, is not exhaustive, may be outdated, and is for reference only. You should consult with your legal advisor to determine how the laws in your location and the regions where you sell medical devices and accessories may affect your business.

If you violate any laws within any jurisdiction where you operate, SHOPLAZZA may remove products or terminate your online store.

Please note that medical devices refer to instruments, apparatus, appliances, software, materials, and other items specially intended by manufacturers for diagnostic and/or therapeutic purposes, whether used alone or in combination, including software required for their proper use.

Chinese manufacturing enterprises should comply with the "Regulations on the Supervision and Administration of Medical Devices. "

This includes:

Medical device product registration certificate or medical device product filing (applicable to Class I medical device products).
Compliance with the quality standards requirements of the importing country (region).

United States (US) Laws and regulations for selling Medical Devices & Accessories：

If you sell medical devices and accessories to customers in the United States, you must adhere to all federal laws and state laws applicable to the jurisdiction where your products are sold and shipped. This includes regulations from the Food and Drug Administration (FDA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act) , which cover the registration, approval, labeling, and marketing of medical devices.

Registration, Approval, and Authorization:

Manufacturers (domestic and foreign) and initial distributors (importers) involved in the production and distribution of medical devices used in the United States must register with the FDA.

Class I and II non-exempt medical devices must be approved by the FDA for sale in the United States. Note that most Class I devices are exempt from 510(k) clearance. For more information, refer to the 510(k) Clearance Guidance .

Note: Class I devices pose the lowest risk, Class III devices pose the highest risk, and Class III devices require Premarket Approval (PMA).
Medical devices must not be on the FDA's warning list .

Labeling:

All medical devices must have labels in English, including:

Name and location of the manufacturer, packer, or distributor, including street address, city, state, and ZIP code.

Instructions for use, including:

Statements regarding all intended uses and conditions for use of the device.
Dosage for each administration and common dosages for different ages and conditions.
Dosage frequency.
Application period.
Relationship between application time and other factors.
Application route or method.
Any preparation required for use.

For more information, refer to:

Marketing:

Information materials or package inserts should be provided on product detail pages, product packaging, and accompanying pages.

Medical devices must not make false or misleading statements.
Medical devices must carry appropriate statements indicating "FDA approved" or "FDA cleared."
FDA logos must not be used on medical devices.

For more information, refer to "Is It Really 'FDA Approved'? " and FDA Name and Logo Policy .

Additional Information on Selling Medical Devices and Accessories in the United States:

Products Prohibited from Sale as per FDA Regulations:

Examples of Prohibited Products .

Canada Laws and regulations for selling Medical Devices & Accessories：

If you sell medical devices and accessories to customers in Canada, you must comply with all relevant provincial, territorial, and local laws, such as the Food and Drugs Act and the Medical Devices Regulations (SOR/98-282) .

As per Canadian laws and regulations, medical devices are defined as any instrument or component used for the treatment, diagnosis, or prevention of diseases or abnormal physical conditions. The range of medical devices is extensive, encompassing items from band-aids, toothbrushes, and contact lenses to complex equipment such as X-ray machines, insulin pumps, and pacemakers. It also includes diagnostic devices like cancer screening tests, blood glucose monitors, and pregnancy test kits.

Medical Device Licensing:

In Canada, medical devices require appropriate medical device licenses for distribution.

Canada issues two types of licenses:

Medical Device License (MDL)
Medical Device Establishment License (MDEL)

For more information, refer to: About Medical Devices .

Classification:

Medical devices are classified into Class I to Class IV based on risk, where Class I represents the lowest risk and Class IV represents the highest risk.

Class I devices do not require a medical device license. However, to import or sell Class I devices, a Medical Device Establishment License (MDEL) is required by:

Manufacturers
Importers
Distributors

Only manufacturers imported or sold by companies holding an MDEL are exempt.

Class II, III, or IV devices require a Medical Device License (MDL). Class II, III, or IV devices cannot be sold or imported in Canada without a valid Medical Device License (MDL).

For more information, refer to: Types of licences for medical devices, by class .

Labeling:

Medical devices sold or used in Canada must comply with the labeling requirements as outlined in the regulations. For more information, refer to: Medical Device Labeling Guide .

Additional Information on Selling Medical Devices and Accessories in Canada:

Compliance with the relevant regulatory quality system: ISO 13485 quality system .
List of valid medical device licenses.
Recalls, advisories and safety alerts.

European Union (EU) Laws and regulations for selling Medical Devices & Accessories：

When selling medical devices to customers in the European Union, you should review all applicable laws, including those of any member state where you plan to sell your products. You must comply with the Medical Devices Regulation (EU) 2017/745 , which includes device classification, compliance requirements, and registration obligations.

In the EU, a medical device is defined as any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used alone or in combination for specific medical purposes in humans.

Classification and Conformity Assessment:

Devices are classified as Class I, IIa, IIb, and III based on the intended purpose and inherent risks.

*Note: The risk class to which a medical device is assigned will determine the conformity assessment route that the medical device must follow.

Class I devices have low risk, while Class III devices have high risk.

Before placing a device on the market, manufacturers must conduct a conformity assessment of the device in accordance with the applicable procedures.

CE Marking:

Every medical device must bear the CE mark to confirm that the device has undergone a conformity assessment. The CE mark must be affixed in a visible, legible, and indelible manner on the device or its sterile packaging and in the instructions for use.

Additionally, manufacturers selling devices under a conformity assessment procedure must notify the competent authorities of the member state where their registered place of business is located with the following information:

Address of the registered place of business,
Description of the device.

For more information, refer to: Authorized Representative.

Authorized Representative:

If a manufacturer does not have a registered place of business in a member state, the manufacturer must appoint an authorized representative in the EU before the device can be placed on the Union market.

Regulatory Compliance Officer:

Manufacturers must have at least one person within their organization responsible for regulatory compliance, possessing the necessary expertise in the field of medical devices.

Additional Information on Selling Medical Devices and Accessories in the EU:

UK (After Brexit) Laws and regulations for selling Medical Devices & Accessories:

In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market. If you are selling items that are or may be considered medical devices in the UK (including accessories for medical devices), you should review all applicable laws, including but not limited to:

UK MDR 2002
Directive 90/385/EEC on active implantable medical devices (EU AIMDD)
Medical Devices Directive 93/42/EEC (EU MDD)
In Vitro Diagnostic Medical Devices Directive 98/79/EC (EU IVDD)

The UK MDR includes requirements for selling medical devices in the UK, including device classification, compliance requirements, and registration obligations. Please note that "medical devices" include in vitro diagnostic medical devices and active implantable medical devices.

Goods sold in the following countries/regions are subject to different rules: (1) United Kingdom (England, Scotland, and Wales); (2) Northern Ireland.

Registration:

All medical devices, including IVDs, custom-made devices, and systems or procedure packs, must be registered with the MHRA before being placed on the UK market.

You must ensure that all information registered with the MHRA is accurate and up to date.
Registration of your device with the MHRA (the UK competent authority) does not imply any form of endorsement, certification, approval, or recognition by the MHRA.
Therefore, you must not make any claims to this effect, including using any MHRA logos in any marketing materials, device packaging, instructions for use, labelling, or any other documents.

For more information, refer to: Registering a medical device to be placed on the market .

Device Classification:

Devices should be classified as General Medical Devices, Active Implantable Devices, and In Vitro Diagnostic Medical Devices (IVD) based on the relevant risk classes.
Before placing devices on the market, manufacturers should assess the devices' conformity according to the applicable conformity assessment procedures.

Conformity Assessment and UKCA Marking:

Every medical device must bear the UKCA mark to confirm that the device has undergone a conformity assessment. The UKCA mark must appear in a visible, clear, and indelible manner on the device or its sterile packaging and in the instructions for use. For more information, refer to: Medical devices: conformity assessment and the UKCA mark.

*Note:

Medical device manufacturers can continue to use the UKCA mark or CE mark on devices placed on the UK market until June 30, 2023. The government has extended the acceptance period for CE marked devices in the UK until after June 30, 2023.

Authorized Representative:

If you are a medical device manufacturer outside the UK and wish to place devices on the UK market, you need to appoint a UK Responsible Person for all your devices to carry out specific tasks on your behalf, such as registration. For more information, refer to: Register medical devices to place on the market .

Labeling Requirements:

Medical devices placed on the UK market must have the UKCA mark or CE mark, depending on which regulation the device has been certified under.
Devices may bear both the CE and UKCA marks on the label. For more information, refer to: Labeling requirements .

For additional information on selling medical devices and accessories in the UK:

Northern Ireland:

Please note that different rules apply to Northern Ireland from January 1, 2021, under the Northern Ireland Protocol . Specifically:

Conformity assessment in Northern Ireland.
Registration and UK Responsible Person requirements in Northern Ireland.
UKNI requirements for Northern Ireland.

For more requirements in Northern Ireland, refer to:

Australian laws and regulations for selling Medical Devices & Accessories:

In Australia, the Therapeutic Goods Administration (TGA) is the authority responsible for overseeing medical device safety, quality control, and vigilance. You should adhere to the Therapeutic Goods Act 1989 and review all applicable laws. Please refer to: Medical devices overview .

Registration:

Before offering any medical devices in the Australian market, they must be registered in the Australian Register of Therapeutic Goods (ARTG) managed by the TGA.

Device Classification:

Devices are classified from Class I (sterile/measuring), IIa, IIb to III, where Class I (sterile/measuring) poses low risk, and Class III poses a high risk.

Authorized Representative:

If a company does not have a physical presence in Australia, they need to appoint a local authorized representative, known as a "Sponsor." The name and contact details of the Australian agent must be indicated on the medical device and its labeling. The Sponsor acts as an intermediary contact between the manufacturer and the TGA, handling any matters related to the product. For example, reporting post-market activities to the TGA, including adverse events reporting and coordinating recalls.

Labeling Requirements:

Australia has specific labeling and packaging requirements for medical devices. These requirements aim to ensure that medical devices are correctly labeled and packaged for safe and effective use. Labels must include the following information:

Name and address of the manufacturer, packer, or distributor
Trade name or brand name of the device
Unique Device Identifier (UDI)
Intended purpose of the device
Instructions for use
Any warnings or precautions
Expiry date (if applicable)
Batch or lot number

For more information, please refer to: Labeling and Packaging.

Market Access:

Australia recognizes certain overseas regulatory approvals such as the CE mark, US FDA approval, and products within the scope of MDSAP certification.

For additional information on selling medical devices and accessories in Australia: