[American Station]
If you want to export a medical product to a US site, you first need to determine whether the product is a “medical device” (Medical Device). The US Food and Drug Administration (FDA) defines a wide range of medical devices. From simple tongue depressors to complex laser surgical devices, they are medical devices. If sellers still don't know whether the products they sell are medical devices, you can search the CDRH database on the US FDA website https://www.fda.gov/medical-devices. If the matching results are insufficient to help determine whether the product is a medical device, you can also send an email to DeviceDetermination@fda.hhs.gov to make a decision through email consultation.
After determining that the product is a medical device, what needs to be done is to determine the medical device class (Class) of the product, because the applications required for Class I to Class III medical devices are completely different. Generally speaking, Class I and Class II are exempt from pre-sale notification applications (Pre-Market Notification commonly known as “510 (k)”). However, if the product is a Class III medical device, a pre-sale notification application is required from the FDA. Also, almost all medical devices require GMP certification. GMP, the full name of Good Manufacturing Practices, mainly requires the provision of documentation to prove that the manufacturer has a qualified quality management system and corresponding product packaging and labeling control. Please refer to FDA Class I and Class II product categories.

1. Registration, customs clearance, approval
1) Owners or operators of organizations involved in the production and distribution of medical devices in the US must register with the FDA. For more information, see Device Registration and Product Information, https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing; 2) Class I and Class II non-exempt medical devices must be approved by the FDA before they can be sold in the US. Please note: Most Class I devices are exempt from 510 (k) customs clearance. For more information, see 510 (k) Customs Clearance: https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/510k-clearances; 3) Class III medical devices must be approved by the FDA before they can be sold in the US. For more information, please refer to Pre-Market Approval (PMA): https://www.fda.gov/medical-devices/premarket-submissions/premarket-approval-pma; 4) Medical devices must not be subject to any unresolved FDA enforcement measures (such as FDA warning letters). For more information, see the warning letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters.
2. labeling
1) All medical devices must be labeled in English and include the following information: a. The name and address of the manufacturer, packager, or distributor, including street address, city, state, and zip code; b. Instructions for use, including: i. A statement of all uses and conditions for which the device may be used; ii. The dose for each use and the amount of use usually used by people of different ages and physical conditions; iii. Frequency of medication; iv. Duration of use; v. Relationship between time of use and other factors; vi. Method or method of administration; vii. Use any preparations required.
2) Prescription medical devices must include an Rx statement, such as: “Note: Federal law restricts the sale of this device by (insert the name of a physician, dentist, or other licensed practitioner) or as ordered by them”;
3) For more information, please refer to the US Food and Drug Administration (FDA) labeling guidelines: https://www.fda.gov/medical-devices/device-labeling/general-device-labeling-requirements.
3. Marketing Promotion The following requirements apply to all product marketing materials, including product detail pages, product packaging, and any accompanying instructional materials or packing instructions.
1) Medical devices must not make false or misleading statements;
2) Medical devices must properly use “FDA cleared” or “FDA approved” declarations. For more information, see “Is it really 'FDA-approved'?”：https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved；
3) Medical devices must not use the FDA logo. For more information, see “Is it really 'FDA Approved'?”；
4) All sellers are prohibited from listing products that are misdescribed as “FDA cleared”, “FDA approved”, or that include the FDA logo in the relevant image. For more information, see “Is it really 'FDA Approved'?” and “FDA logo policy.”

Europe Marketplace
In Europe, if the product being sold is or may be a medical device (including accessories for medical devices), then it should comply with the Medical Devices Directive 93/42/EEC (“MDD” for short). The MDD contains EU requirements for the sale of medical devices (including device classification, compliance, and registration obligations). Note that in vitro diagnostic medical devices and implants are not subject to MDD, but they are subject to two other directives: Directive 98/79 and Directive 90/385.

MDD, Directive 98/79, and Directive 90/385 will soon be replaced by two new regulations. The new regulations on medical devices will come into effect on May 26, 2020 after a transition period. The new regulations on in vitro diagnostic medical devices will come into effect on May 26, 2022 after a transition period. All sellers are responsible for complying with all medical device rules and regulations. This material is for informational purposes only and is not legal advice. If you have questions about the laws and regulations relating to your products, it is recommended that you consult your legal advisor and refer to the relevant country's laws and regulations.

Also, it is important to note that before cosmetics products are sold in Europe, they must be registered on the Cosmetic Products Notification Portal (CPNP) before they can be sold. For more information about CPNP, please refer to: https://webgate.ec.europa.eu/cpnp/faq/?event=faq.show
Japan Marketplace
Japan's current compliance requirements require compliance with the Ministry of Health and Welfare (HIMV) certification requirements. At the same time, local Japanese companies are required to act as agents to be responsible for product registration, customs clearance, and customs declaration. Among them, specialized equipment for hospitals (see the three types of medical devices in the US) requires certified factories. The label and operation can be found in the US. For more information, see https://web.fd-shinsei.go.jp/application/list_drug.html.
Compliance instructions for each Seller Central site
For more information on compliance instructions for each [Medical Devices] site, please refer to the [Seller Central] link:
North America:
https://sellercentral.amazon.com/gp/help/help.html?itemID=200164650&language=en_US&ref=ag_200164650_cont_200164330
Europe:
https://sellercentral.amazon.co.uk/gp/help/GKGRK6FV9X8TJDB?language=en_GB&ref=ag_GKGRK6FV9X8TJDB_cont_GUH6FA4XSJ2LZFLY

Compliance Service Provider References
Compliance service providers can refer to Seller Central SPN (Service Provider Network): https://sellercentral.amazon.com/tsba/searchpage/Compliance?ref_=sc_spn_hp_colst&sellFrom=CN&sellIn=US The testing product range has basically achieved comprehensive coverage and will continue to be updated.

National regulatory requirements

Health food has a certain certification threshold. Recommended sellers in North America and Europe have local companies or partner companies, which can obtain certification advantages. However, the current channel for China's exports to Japan is for Japanese companies to report on their behalf, and they can be freely sold after customs declaration. Please keep the following in mind:

1. wraps
1) It must be in the original manufacturer's packaging;
2) The product is new and unused, and the outer packaging is complete and undamaged; 3) The identification code placed on the package by the manufacturer or distributor, such as a matrix code, batch number, or serial number, must be clearly displayed.

2. labeling
1) Supplements must indicate the following information in English: a. The name of the dietary supplement; b. The total amount of the dietary supplement (e.g. 100 tablets, 5 mg, 6 oz); c. List of ingredients; d. The name and address of the manufacturer or distributor.
2) Unless approved by the FDA, the supplement label must not state that the product cures, mitigates, treats, or prevents human diseases;
3) The supplement label cannot claim that the product has the same effect as a controlled substance or prescription drug (e.g., supplements must not have names confused with controlled substances or prescription drugs, such as “Viagrex” or “testosterone”);
4) Do not write “FDA approved” on supplement labels;
5) Supplement labels must not use the FDA logo;
6) The supplement label must not indicate “inspector”, “non-retail” or “non-resale”;
7) For more information, please refer to the US Food and Drug Administration (FDA) Dietary Supplement Labeling Guidelines: “Are they really 'FDA approved'?” Related link: https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved.

3. Marketing promotion
1) The detail page must include the following information: a. The name of the dietary supplement; b. The ingredient list, including the ingredient list on the product label.
2) Products cannot be used to cure, mitigate, treat or prevent human diseases unless approved by the FDA;
3) Detailed pages cannot include disease names in keywords;
4) Detailed pages must not state that products have the same effects as controlled substances or prescription drugs (for example, supplements must not state that they are substitutes for prescription drugs, or that they are as effective as prescription drugs);
5) The detailed page cannot claim that the product produces effects similar to anabolic steroids, such as “legal steroids”;
6) The detail page does not state that the supplement is “FDA-approved”;
7) Images associated with detail pages must not include the FDA logo.

Compliance instructions for each Seller Central site
For more information on compliance instructions on each site of “Nutraceutical Products”, please refer to the “Seller Central” link:
North America:
https://sellercentral.amazon.com/gp/help/help.html?itemID=200164650&language=en_US&ref=ag_200164650_cont_200164330
Europe:
https://sellercentral.amazon.co.uk/gp/help/GKGRK6FV9X8TJDB?language=en_GB&ref=ag_GKGRK6FV9X8TJDB_cont_GUH6FA4XSJ2LZFLY

Compliance Service Provider References

Compliance service providers can refer to Seller Central SPN (Service Provider Network): https://sellercentral.amazon.com/tsba/searchpage/Compliance?ref_=sc_spn_hp_colst&sellFrom=CN&sellIn=US The testing product range has basically achieved comprehensive coverage and will continue to be updated.