Regulatory ESSENTIAL
China - X-RAY Device

Scope of this ESSENTIAL

This ESSENTIAL describes the legal obligations for manufacturers and the regulatory requirements for electronic product radiation in China.'

Analysis of regulatory requirements

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)?

Scope of legislation

Mandatory standard like legislation: GB 18871-2002 3.1.1. The practice applicable to this standard shall include: a) Source production and radiation or radioactive substance application in medical, industry, agriculture or teaching and research, including various activities related to application involved or possibly involved in radiation or radioactive substance exposure 3.1.2.1 The source applicable to the requirements of this standard for practice shall include: a) Radioactive substance and component containing radioactive substance or generating radiation, including consumer product, sealed source, unsealed source and radiation generator; b) Device and facility with radioactive substance and equipment generating radiation, including irradiation installations, mine or mill processing radioactive ores, installation processing radioactive substances, nuclear installation and radioactive waste management facility; c) Other sources specified by regulatory authority Article 68 of the Radioisotope and radiation device safety and protection regulations - Radioactive isotope, refers to a radioactive decay of an element with the same atomic number but different mass nuclide - Radioactive devices, refers to X-ray machines, gas pedals, neutron generators and devices containing radioactive sources. - With the generation of X-rays electrical products, is not to generate X-rays for the purpose, but in the production or use of the process of generating X-rays of electrical products. Article 37 The radiation protection equipment, equipment containing radioactive isotopes and radiation devices, as well as products containing radioactive substances and electrical products accompanied by the generation of X-rays, should meet the radiation protection requirements. '

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)

Penalty by this legislation

here you will get textual information What are the possible penalties (e. g. sales ban, fines) in the case of non-compliance?

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 related hyperlink(s) Has the country signed a Free Trade Agreement (FTA) or a Mutual recognition agreement (MRA) with EU?

Authority

here you will get related hyperlink(s) Name of the authority for approval, registration, market surveillance and/or enforcement

Link/Reference to other reference document(s)

here you will get related hyperlink(s)

Hints

here you will get textual information 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

Is the IECEE CB Scheme accepted by the authority/approval body?

here you will get textual information "[Yes/ No / no information available] [Text] Information (website)"

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

Digital user documentation allowed?

here you will get textual information User instructions allowed by QR-Code/internet or digital medium or integrated in device with display? Safety instruction allowed by QR-Code or digital medium?

Warnings, symbols

here you will get textual information e. g. ANSI Z 535.4

Hints

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

Code, Continent	CHN, Asia
Economic Area	APEC (Asia-Pacific Economic Cooperation)
Official Language	Chinese (Mandarin) - Law of the People's Republic of China on the Standard Spoken and Written Chinese Language | http://www.npc.gov.cn/zgrdw/englishnpc/Law/2007-12/11/content_1383540.htm
Standard Institute	Standardization Administration of China (SAC) | https://www.sac.gov.cn/
HS Codemember	Yes