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EU RoHS Directive revised further affects the export of Chinese medical products

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EU RoHS Directive revised further affects the export of Chinese medical products

  • Categories:Industry News
  • Author:
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  • Time of issue:2012-03-22 10:03
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(Summary description)    EU member states continue to strengthen law enforcement, the impact will inevitably directly affect China. Recently, the European Union's green directive RoHS ("Restriction on the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Directive") has been revised to extend the scope of application to medical and monitoring equipment. In addition, 4 types of hazardous substances have been added as priority evaluation substances, which will It has a major impact on the export of China's home appliance companies. The European Commission issued the "Recommendation on the Rewriting of the European Parliament and Council Directive on the Restriction of the Use of Certain Hazardous Substances (RoHS) in Electrical and Electronic Equipment (COM (2008) 809 Final Edition)", which proposed to rewrite the current Directive 2002 /95/EC (RoHS Directive). The committee’s proposal maintains key elements of the current directive, such as the list of prohibited substances (no addition or removal of substances) and the possibility of granting exemptions for these substances in certain application areas.    The proposal includes the following major changes:    1. Clarified the scope and definition, especially by establishing a binding list of products to define the scope of the RoHS directive.    2. The use of EU product sales, especially the relevant provisions already used in the package of regulations on national sales supervision activities and mechanisms for product conformity assessment.    3. Adapted the exemption procedure, such as granting an exemption by adopting additional socioeconomic standards, and requiring applicants to analyze alternatives before submitting the request, and the maximum validity period is 4 years.    4. A stepwise approach is included in the RoHS scope of medical devices and control and monitoring instruments.    5. Established a clear identification mechanism.   Shanghai Medical Device Industry Association

EU RoHS Directive revised further affects the export of Chinese medical products

(Summary description)
  

EU member states continue to strengthen law enforcement, the impact will inevitably directly affect China. Recently, the European Union's green directive RoHS ("Restriction on the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Directive") has been revised to extend the scope of application to medical and monitoring equipment. In addition, 4 types of hazardous substances have been added as priority evaluation substances, which will It has a major impact on the export of China's home appliance companies.

The European Commission issued the "Recommendation on the Rewriting of the European Parliament and Council Directive on the Restriction of the Use of Certain Hazardous Substances (RoHS) in Electrical and Electronic Equipment (COM (2008) 809 Final Edition)", which proposed to rewrite the current Directive 2002 /95/EC (RoHS Directive). The committee’s proposal maintains key elements of the current directive, such as the list of prohibited substances (no addition or removal of substances) and the possibility of granting exemptions for these substances in certain application areas.

   The proposal includes the following major changes:

   1. Clarified the scope and definition, especially by establishing a binding list of products to define the scope of the RoHS directive.

   2. The use of EU product sales, especially the relevant provisions already used in the package of regulations on national sales supervision activities and mechanisms for product conformity assessment.

   3. Adapted the exemption procedure, such as granting an exemption by adopting additional socioeconomic standards, and requiring applicants to analyze alternatives before submitting the request, and the maximum validity period is 4 years.

   4. A stepwise approach is included in the RoHS scope of medical devices and control and monitoring instruments.

   5. Established a clear identification mechanism.

  Shanghai Medical Device Industry Association

  • Categories:Industry News
  • Author:
  • Origin:
  • Time of issue:2012-03-22 10:03
  • Views:
Information

  

EU member states continue to strengthen law enforcement, the impact will inevitably directly affect China. Recently, the European Union's green directive RoHS ("Restriction on the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Directive") has been revised to extend the scope of application to medical and monitoring equipment. In addition, 4 types of hazardous substances have been added as priority evaluation substances, which will It has a major impact on the export of China's home appliance companies.

The European Commission issued the "Recommendation on the Rewriting of the European Parliament and Council Directive on the Restriction of the Use of Certain Hazardous Substances (RoHS) in Electrical and Electronic Equipment (COM (2008) 809 Final Edition)", which proposed to rewrite the current Directive 2002 /95/EC (RoHS Directive). The committee’s proposal maintains key elements of the current directive, such as the list of prohibited substances (no addition or removal of substances) and the possibility of granting exemptions for these substances in certain application areas.

   The proposal includes the following major changes:

   1. Clarified the scope and definition, especially by establishing a binding list of products to define the scope of the RoHS directive.

   2. The use of EU product sales, especially the relevant provisions already used in the package of regulations on national sales supervision activities and mechanisms for product conformity assessment.

   3. Adapted the exemption procedure, such as granting an exemption by adopting additional socioeconomic standards, and requiring applicants to analyze alternatives before submitting the request, and the maximum validity period is 4 years.

   4. A stepwise approach is included in the RoHS scope of medical devices and control and monitoring instruments.

   5. Established a clear identification mechanism.

  Shanghai Medical Device Industry Association

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