July 21, 2011 , the EU issued a new version of the RoHS Directive ( Restriction of Hazardous Substances Directive , 2011/65/EU) came into effect. Compared with the original directive , the new directive controls should be extended to all electrical and electronic equipment . In addition , the new directive also adds new restricted substances procedural requirements , stricter enforcement and product recall mechanism, and products to be attached CE Mark ( European Common Market safety signs ) and so on. In this regard , the respondents Insiders said that this policy really play effects may take some time ; same time, many companies today already meet the original product exports to the EU RoHS Directive standards, and also by the European Common Market Safety Mark (CE) certification, short-term impact will not be affected by the new directive .

Compared with the original directive , the new RoHS directive controls should be extended to all electrical and electronic equipment, including medical equipment, surveillance equipment, and are not included in the previous ten electrical and electronic equipment among 11 categories of products . It is reported that , although the new directive will include all the cables and spare parts , including electrical and electronic products are covered by the directive within the scope of the regulation , but given a new section 8 Class II medical devices , Class 9 Monitoring and control instruments ( including industrial monitoring and control instruments ) certain transition period , and these two products gives 20 exemption. However, in accordance with the provisions of the EU member states need to January 2, 2013 to be translated into national law , and to develop regulations and related Penalties .

"All along, China's medical device related standards are not perfect from the number of terms , China's medical equipment industry standard is far from foreign standards and refinement ; qualitatively speaking, China's medical equipment industry standard is also far more foreign low , ie , in our country through the medical device industry-standard products , but not necessarily in a foreign country through the appropriate standard . " CIC drug industry researcher Liu said in an interview , the EU RoHS Directive means that the future of modifying medical device industry will enter a "high standard era ."

However, the Chinese Medicines and Health Products Import and Export Chamber of Commerce official says : "At present , the new beginning of the implementation of the RoHS directive , many companies may not be able to react and respond in a timely manner , this policy really play effects may take some time ."

There are some export business to Europe on the new directive medical device companies are still not well understood. However, because many companies had already done a number of certification , RoHS limited impact of the new directive . Asia-Link Technology Co., Ltd. Beijing Hengtai Director of Operations Gong Qing Gang said , "The new directive on the impact of the medical device industry itself is not great, because the industry Material Safety requirements and testing standards already high ."

Xiamen Comfort Science & Technology ( Group ) Co., Ltd. R & D department certified engineers Cui Pengfei also hold similar views . He told: "We have to get there from upstream producers of raw materials processed combination of these materials has met the original RoHS Directive standards, and also got the CE certification , so our production and R & D is not much impact ."

Of new equipment Shanghai Co., Ltd. Mr. Dong said the company is producing and exporting the EU's medical device products have passed CE certification, is not affected by the new impact of the introduction of the RoHS directive , but has not yet received instructions on this new certification standards matters . " However, he said , if there is certification needs, the company will certainly be prepared in advance .

CE mark for the EU provisions attached , the industry believes that , because of Chinese exports to the EU energy-using products must be certified through the relevant agencies before they can attach the CE mark , so this provision would increase 2% to 5 % of the production costs . According to regulations, electrical and electronic equipment put on the market before the products , manufacturers, importers and distributors must ensure that the modules according to 768/2008/EC Annex II A conformity assessment procedures have been assessed and must be affixed in the final product CE marking .

RoHS Directive is European legislation enacted a mandatory standard , on July 1, 2006 formally implemented. The directive requires all EU sale in the market in electrical and electronic equipment prohibit the use of lead, mercury , cadmium, hexavalent chromium and other heavy metals and polybrominated diphenyl ethers (PBDE) and polybrominated biphenyls (PBB) and other flame retardants .

Liu suggested that the relevant enterprise, because the new directive will be formally implemented in 2013 , so companies should pay attention to collect information related to the new version of the RoHS Directive and developments, to carry out targeted response , new businesses should try on their products comply with the RoHS Directive sex for verification. Meanwhile, we should strengthen communication with relevant technical departments , define their product is affected by the revised directive influence on the declaration of conformity and CE certification needed to prepare the relevant documents necessary for rectification. In addition, to take the initiative to communicate with the customer contact and communication with the industry responses to ensure smooth export the EU market.

( Source: International Business Daily )