Regulatory ESSENTIAL
USA - Medical Devices Cybersecurity

Analysis of regulatory requirements

Legislation in force for this PCT

here you will get textual information Are legal provisions regulates the product compliance topic? If yes, what is the reference (title, number)?

Legislation in force for this PCT

here you will get a linked document in ROGER WILLCO (only reachable with additional ROGER WILLCO licence) Are legal provisions regulates the product compliance topic? If yes, what is the reference (title, number)?

Legislation in force for this PCT

here you will get related hyperlink(s) Are legal provisions regulates the product compliance topic? If yes, what is the reference (title, number)?

Legislation in force for this PCT

here you will get a image or chart Are legal provisions regulates the product compliance topic? If yes, what is the reference (title, number)?

Scope of legislation

CFR Title 32 – National Defense - Contractors of the DEPARTMENT OF DEFENSE (DoD) are required to report cyber incidents. - Voluntary DEFENSE INDUSTRIAL BASE (DIB) CYBER SECURITY (CS) program, purposed to to share cyber threat information and cybersecurity best practices. '

Responsible actors

here you will get textual information Which actor(s) are responsible for compliance with the legal provisions: e. g. - economic operators (manufacturer, importer, distributor, fulfilment service provider), - user (commercial/industrial/professional), - user (private, consumer)?

Authority

here you will get textual information Name of the authority for approval, registration, market surveillance and/or enforcement

Hints

here you will get textual information Specific recommendations, information or most common mistakes

Hints

here you will get a linked document in ROGER WILLCO (only reachable with additional ROGER WILLCO licence) Specific recommendations, information or most common mistakes

Hints

here you will get related hyperlink(s) Specific recommendations, information or most common mistakes

Route to compliance

Formal and administrative requirements

Registration at related authority required?

here you will get textual information Product registration? Manufacturer registration? Importer / Representative registration? if required.

Equipment authorization (approval process)

Approval process (conformity assessment procedure)

here you will get textual information Means each legally required approval process prior placing on the market, importation or putting into service

Is a factory inspection legally required

here you will get textual information

Testing & Standards

Specific requirements for testing

here you will get textual information e. g. is an accredited test lab. mandatory, limits, test samples, product description

Specific requirements for testing

here you will get a image or chart e. g. is an accredited test lab. mandatory, limits, test samples, product description

Specific requirements for testing

here you will get related hyperlink(s) e. g. is an accredited test lab. mandatory, limits, test samples, product description

Hints

here you will get related hyperlink(s) Specific recommendations, information or most common mistakes

Hints

here you will get textual information Specific recommendations, information or most common mistakes

Regulatory labelling, markings and user information

Regulatory label (mandatory)

here you will get textual information e. g. product label

Hints

here you will get a image or chart Specific recommendations, information or most common mistakes

Analysis of regulatory requirements

Legislation in force for this PCT

here you will get related hyperlink(s) Are legal provisions regulates the product compliance topic? If yes, what is the reference (title, number)?

Scope of legislation

here you will get related hyperlink(s)

Responsible actors

here you will get textual information Which actor(s) are responsible for compliance with the legal provisions: e. g. - economic operators (manufacturer, importer, distributor, fulfilment service provider), - user (commercial/industrial/professional), - user (private, consumer)?

Regulatory market access conditions for the actor(s)

here you will get textual information What are the main regulatory requirements (e. g. conformity assessment fulfilment of essential requirements of Annex I 2006/42/EC) prior placing on the market, importation and putting into service (brief description)

Regulatory market access conditions for the actor(s)

here you will get related hyperlink(s) What are the main regulatory requirements (e. g. conformity assessment fulfilment of essential requirements of Annex I 2006/42/EC) prior placing on the market, importation and putting into service (brief description)

Exemption clauses

here you will get textual information Exempted devices/products or industry sectors.

Sub-federal legislation of states/counties

here you will get textual information E. g. by 2019 an Inter-Governmental Agreement (IGA) on governance of the Electrical Equipment Safety System (EESS) has been signed by Queensland, Victoria, Western Australia and Tasmania.

FTA/MRA status with EU

here you will get textual information Has the country signed a Free Trade Agreement (FTA) or a Mutual recognition agreement (MRA) with EU?

Authority

here you will get textual information Name of the authority for approval, registration, market surveillance and/or enforcement

Link/Reference to other reference document(s)

here you will get textual information

Hints

here you will get related hyperlink(s) Specific recommendations, information or most common mistakes

Route to compliance

Formal and administrative requirements

Registration at related authority required?

here you will get textual information Product registration? Manufacturer registration? Importer / Representative registration? if required.

Local representative legally required?

here you will get textual information [Yes/No]

Hints

here you will get textual information Specific recommendations, information or most common mistakes

Equipment authorization (approval process)

Approval process (conformity assessment procedure)

here you will get textual information Means each legally required approval process prior placing on the market, importation or putting into service

Conformance document(s) to show compliance to the authority

here you will get textual information e. g. SDoC, technical documentation (for 10 years), filled-in approval forms (e. g. ACMA in AUT)

Conformance document validity and renewal

here you will get textual information Validity for Conformance document name mentioned. For mandatory certification validity is important.

Which documents are required by an approval body?

here you will get textual information e .g. formal application

Is a factory inspection legally required

here you will get textual information

Hints

here you will get textual information Specific recommendations, information or most common mistakes

Testing & Standards

Specific requirements for testing

here you will get textual information e. g. is an accredited test lab. mandatory, limits, test samples, product description

General information to the application of standards

here you will get textual information e. g. China: GB standards are mandatory, EU: harmonized standards shall be published in the OJEU with respect to "presumption of conformity"

Source for standards for conformity assessment

here you will get related hyperlink(s)

Is in-country testing legally required?

here you will get textual information

Acceptance of foreign test reports

here you will get textual information

Hints

here you will get textual information Specific recommendations, information or most common mistakes

Regulatory labelling, markings and user information

Regulatory label (mandatory)

here you will get textual information e. g. product label

Regulatory e-labelling allowed?

here you will get textual information e. g. put the regulatory information and labels in a software menu

Required information on the product and/or packaging

here you will get textual information e. g. address of the manufacturer/importer, serial number

User instructions language(s)

here you will get textual information Regulated by the legal provisions

User instruction requirements and specific compliance notes

here you will get textual information Form, sentence inside, simple text. E. g. FCC/ISED compliance information, SAR information, battery, environmental information like waste

Hints

here you will get textual information Specific recommendations, information or most common mistakes

Code, Continent	USA, North America
Economic Area
Official Language	The United States of America doesn’t have an official language on the federal level. They do use English as the primary language for official documents and publications, legislation, orders, regulations and rulings. The states with English as the only official language are: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Louisiana, Massachusetts, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Carolina, North Dakota, South Carolina, South Dakota, Tennessee, Utah, Virginia and Wyoming. Puerto Rico has declared Spanish the principal language, but both English and Spanish are official languages. In the US Virgin Islands, only English is official, while American Samoa has English and Samoan. Guam has English and Chamorro has official languages and in the Northern Mariana Islands, English, Chamorro and Carolinian are official.
Standard Institute	American National Standards Institute - ANSI | https://ansi.org/
HS Codemember	Yes, since 1970