Medical Devices & Covid-19 Products Policy

Medical Devices & Accessories

If you supply Medical Devices & Accessories for sale on SHOPLAZZA, you need to comply with the laws and regulations that apply to your business. These laws and regulations depend on the region where your store is located and the region where you sell.

You're responsible for reviewing and using this information appropriately. This content doesn't contain and isn't meant to provide legal advice. You should consult your legal counsel to determine how the laws in your region and the region in which you sell Medical Devices & Accessories might affect your business. If you violate a law in any jurisdiction where you conduct business, SHOPLAZZA may remove products or terminate your online store.

*Medical device is any instrument, apparatus, appliance, software, material, or another article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application.

Chinese manufacturers shall comply with the “Medical Device Supervision and Management Regulations” and “China's prohibited and restricted exports of technology directory”.

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

If you sell Medical Devices & Accessories to customers in the United States, then you're required to follow all federal laws, and local laws applicable to the jurisdiction into which your products are sold, as well as the jurisdiction from which you ship. These include Food and Drug Administration (FDA) regulations, Federal Food, Drug, and Cosmetic Act (FD&C Act) around registration, labeling, marketing, and prohibited listings for all sellers.

Prohibited listings for sale per FDA regulations

Examples of prohibited listings

Registration, Clearance, and Approval

Manufacturers (both domestic and foreign) and initial distributors (importers) that are involved in the production and distribution of medical devices intended for use in the U.S. must be registered with the FDA.
Class I and Class II non-exempt medical devices must be cleared by the FDA for sale in the U.S. Note that most Class I devices are exempt from 510(k) clearance.

* Note：Class I devices pose the lowest risk and Class III devices pose the greatest risk, Class III devices are required for Premarket Approval (PMA).

Medical devices must not have been the subject of any unresolved FDA enforcement such as FDA warning letters.

Labeling

The name and place of business of the manufacturer, packer, or distributor, including the street address, city, state, and zip code;
Adequate Directions for use

Marketing

Medical devices must not use the FDA logo or make false or misleading statements, use the claims 'FDA cleared' or ‘FDA approved’ appropriately.

Additional information about selling Medical Devices & Accessories in the United States

Canada Laws and regulations for selling Medical Devices & Accessories

If your business is located in Canada, or if you sell Medical Devices & Accessories to customers in Canada, then you're required to follow all applicable provincial, territorial, and municipal laws. You must also follow the Medical Devices Regulations (SOR/98-282).

Classification

Medical devices are classified into one Classes I to IV by means of the classification rules set out in Schedule 1, where Class I represents the lowest risk and Class IV represents the highest risk.

Application for a Medical Device License

An application for a medical device license shall be submitted to the Minister by the manufacturer of the medical device in a format established by the Minister and shall contain the following.

Labeling

All medical devices must have a label which provides the information specified in Section 21(1), (a) to (j) of the Regulations.

Additional information about selling Medical Devices & Accessories in Canada

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

If your business is located in the European Union, or if you sell medical devices to customers in the European Union, you should review all applicable pieces of legislation, including the laws of any member state where you intend to sell your products. You're required to follow the directive Regulation (EU) 2017/746 and Regulation (EU) 2017/745 on medical devices. includes device classification, compliance requirements, and registration obligations.

Classification and Conformity assessment

Devices shall be divided into classes I, IIa, IIb, and III, taking into account the intended purpose of the devices and their inherent risks.

*Note:

Class I devices pose a low risk and Class III devices pose a high risk.

The risk level of the assigned classification of the medical device will determine which conformity assessment path must be followed for that medical device.

Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures.

CE marking of conformity

Each medical device must bear a CE mark confirming that the device has undergone and passed the conformity assessment. The CE mark must appear in a visible, legible and indelible form on the device or its sterile pack, and on the instructions for use.

Furthermore, any manufacturer who sells a device in accordance with the conformity assessment procedures is required to inform the competent authorities of the Member State in which he has his registered place of business of:

1. the address of the registered place of business,

2. the description of the devices concerned.

Authorized representative

If a manufacturer does not have a registered place of business in a Member State, the manufacturer is required to designate a single authorized representative in the European Union.

Person responsible for regulatory compliance

Manufacturers shall have available within their organization at least one person responsible for regulatory compliance was the requisite expertise in the field of medical devices.

Additional information about selling Medical Devices & Accessories in the European Union

*legally non-binding guidance documents to assist merchants in implementing directives related to medical devices

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

If you are selling items in the UK that are or might be medical devices (including accessories of medical devices), you should consult the Medical Devices Regulations 2002 SI 2002/618 (the “UK MDR”). The UK MDR contains the UK requirements for selling medical devices, including device classification, compliance requirements, and registration obligations. Please note that in vitro diagnostic medical devices and implantable devices are also covered by the UK MDR.

Different rules apply to goods you sell in: (1) Great Britain (England, Scotland and Wales); and (2) Northern Ireland.

Classification

Devices shall be divided into General medical devices, Active implantable devices, In vitro diagnostic medical devices (IVDs), depending on the level of risk associated with them.
Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures.

Conformity assessment and UKCA marking

Each medical device must bear a UKCA mark confirming that the device has undergone and passed the conformity assessment. The UKCA mark must appear in a visible, legible, and indelible form on the device or its sterile pack, and the instructions for use.

Furthermore, any manufacturer who sells certain medical devices in the UK, under his own name and with a registered place of business in the UK, is required to register with the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) and provide details of:

1. the address of their registered place of business in the UK;

2. the description of the devices concerned.

*Note:

In Great Britain (England, Wales and Scotland), devices must conform to the UK MDR 2002, the EU MDR (until 30 June 2023), or the EU IVDR (until 30 June 2023) in order to be registered with the MHRA.

From 1 July 2023, a UKCA marking will be required in order to place a device on the Great Britain market.

Authorized representative

If you are a medical device manufacturer based outside the UK and wish to place a device on the Great Britain market, you need to appoint a single UK Responsible Person for all of your devices, who will act on your behalf to carry out specific tasks, such as registration.

Northern Ireland

Please note that different rules apply in NI from 1 January 2021 as a result of the Northern Ireland Protocol. In particular:

* Conformity assessments for Northern Ireland.

* Registration and UK Responsible Person requirements for Northern Ireland.

* UKNI requirements for Northern Ireland

For further requirements in Northern Ireland, please see:

Guidance on the application of the MDR and IVDR in Northern Ireland
Registration of custom-made devices in Northern Ireland

Additional information about selling Medical Devices & Accessories in the UK

Custom-made medical devices in Great Britain

Covid-19 Products Policy

Shoplazza reminds merchants of some of our rules for listings:

Health claims and misuse of keywords: Listings containing health claims and misusing terms such as "virus" or "epidemic" are prohibited.
Prices inflated above market value: Listings that attempt to profit from tragedies and disasters (such as the Coronavirus outbreak) are prohibited.

Shoplazza strongly advises sellers to consult your legal counsel and comply with local laws and regulations when listing. If you violate a law in any jurisdiction where you conduct business, SHOPLAZZA may remove products or terminate your online store.

Sale of Personal Protective Equipment (PPE)

There are now restrictions on the sale of certain Personal Protective Equipment (PPE) including disposable face masks; disposable gloves; disposable gowns; goggles, glasses or eye visors; alcohol wipes; and hand sanitiser.

China export requirements

1) medical device product registration certificate,

2) conform to the quality standards of the importing country (region) requirements.

Fill in requirements for Non-medical mask manufacturers and Medical mask manufacturers, see the table below:

Mask Type	Agreed on applicable standards	Regulatory basis	Qualification requirements
Medical masks	Chinese standard	Announcement 5 www.nmpa.gov.cn	Medical device product registration information can be found on the website of the Food and Drug Administration
Medical masks	Export standard	Announcement 12 www.cccmhpie.org.cn	In the "white list" of medical supplies (medical masks) of the Medical Insurance Chamber of Commerce
Non-medical masks	Chinese standard	Announcement 12 www.samr.gov.cn	Not on the "blacklist" of the State Administration for Market Regulation
Non-medical masks	Export standard	Announcement 12 www.cccmhpie.org.cn	In the "white list" of non-medical masks by the Medical Insurance Chamber of Commerce

USA Laws and Regulations for selling PPEs

PPEs are reviewed by the FDA before they can be legally sold in the United States, your products shall comply with Premarket Notification or 510(k) clearance, and the manufacturers have to show they meet specific criteria for performance, labeling, and intended use to demonstrate substantial equivalence.

During a public health emergency, the FDA issued Emergency Use Authorization (EUA) authority for Covid-19 products, more information on the duration of a EUA can be found in Emergency Use Authorization of Medical Products and Related Authorities, and sections 564(f) and 564(g)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and Enforcement policy guidance documents

For additional information, see

European Union Laws and Regulations for selling PPEs

It is your responsibility to comply with the Regulation (EU) 2016/425 on Personal Protective Equipment if you are selling PPE in the EU. You must also comply with any other national requirements in the countries in which you sell these products.

The following information must be included on the product itself or, where that is not possible, on its packaging or in a document accompanying the product:

1. The name or registered trademark and postal address of the manufacturer and/or EU importer

2. The type, batch or serial number, or other element allows the identification of the PPE

3. The CE mark. All information must be included in the local language of the country in which it is sold.

*Note: For more information about the obligations of manufacturers, importers, and distributors of PPE, please see Personal protective equipment (PPE)

UK (After BREXIT) Laws and Regulations for selling PPEs

The UK requirements for PPE apply to all products sold in the UK, but the provisions apply differently to Great Britain ("GB") (England, Scotland, and Wales) and Northern Ireland ("NI").

The following information must be included on the product itself or, where that is not possible, on its packaging or in a document accompanying the product:

1. The name or registered trademark and postal address of the manufacturer and UK importer

2. The type, batch or serial number, or other element allowing the identification of the PPE

3. UKCA mark. All information must be included in clear, understandable, intelligible, and legible English.

*Note: CE marking will be accepted in GB until 1 January 2022, and that additional means of affixing the UKCA mark will be accepted until 1 January 2023.

In Northern Ireland

Please note that different rules will apply in NI from 1 January 2021 as a result of the Northern Ireland Protocol. Manufacturers should be fully aware of the laws and regulations relating to PPE products in Northern Ireland:

For more information on the requirements for PPE in the UK, visit the UK Government website

Personal protective equipment (PPE) at work

Australia Laws and Regulations for selling PPEs

Since 30 Jan 2020, it is illegal to resell PPE purchased at retail for more than 120% of its purchase price
In addition, the Government has introduced restrictions banning these items from export.