IVD\u548c\/\u6216MD\u5236\u9020\u5546\uff1f<\/p>\n\n\n\n
\u4f4d\u4e8e\u745e\u58eb\u5883\u5916\uff1f<\/p>\n\n\n\n
\u5728\u745e\u58eb\u9500\u552e\u60a8\u7684\u4ea7\u54c1\uff1f<\/p>\n\n\n\n
\u60a8\u9700\u8981\u745e\u58eb\u6388\u6743\u4ee3\u8868\uff01<\/strong><\/p>\n\n\n\n \u201c\u745e\u58eb\u533b\u7597\u5668\u68b0\u6388\u6743\u4ee3\u8868\u201d\/\u201cCH-REP\u201d\u662f\u6307\u5728\u745e\u58eb\u8bbe\u7acb\u7684\u81ea\u7136\u4eba\u6216\u6cd5\u4eba\uff0c\u53d7\u56fd\u5916\u5236\u9020\u5546\u4e66\u9762\u59d4\u6258\uff0c\u4ee3\u8868\u5176\u6267\u884c\u67d0\u4e9b\u4efb\u52a1\uff0c\u4ee5\u5c65\u884c\u672c\u6761\u4f8b\u89c4\u5b9a\u7684\u5236\u9020\u5546\u4e49\u52a1\u3002<\/p>\n\n\n\n Ensure Your Medical Device Meets Swiss Regulations With a Leading Expert.<\/p>\n\n\n\n Switzerland is not a member of the European Union. Means a EU-REP isn’t valid vor Switzerland. You need a CH-REP. The CH-REP is responsible for compliance with Swiss regulations and laws and must be appointed by July 31, 2022 so that medical devices of class I that are already on the Swiss market can continue to be placed on the market there.<\/p>\n\n\n\n Therefore, medical device and IVD manufacturers without a registered office in Switzerland must now appoint a local Swiss Authorized Representative (CH-REP).<\/p>\n\n\n\n Since May 26, 2021, foreign manufacturers of medical devices have had to appoint a Swiss authorized representative in order to be able to place their products on the Swiss market.<\/p>\n\n\n\n The CH-REP also has access to the technical documentation and must ensure that the products meet the requirements of the Swiss regulatory and supervisory authority for medicinal products and medical devices, Swissmedic.<\/p>\n\n\n\n We can also help you to find the right sales partner and setup a sales network in Switzerland. Up to taking over the sales for you in Switzerland.<\/p>\n\n\n\n We also offer service contracts for your products to ensure your after sales service meets your needs.<\/p>\n\n\n\n We can take over this task for you. If you are interested, just talk to us on WeChat or Ding Talk. By just scann simple one of the QR Code below. <\/p>\n\n\n\n An IVD and\/or MD manufacturer?<\/p>\n\n\n\n Located outside Switzerland?<\/p>\n\n\n\n Selling your products in Switzerland?<\/p>\n\n\n\n A „Swiss authorized representative for medical devices“ \/ „CH-REP“ is a natural or legal person established in Switzerland who is commissioned in writing by a manufacturer based abroad to carry out certain tasks on his behalf in fulfillment of the manufacturer’s obligations arising from this ordinance to perceive.<\/p>\n\n\n\n \u4e0e\u9876\u5c16\u4e13\u5bb6\u4e00\u8d77\u786e\u4fdd\u60a8\u7684\u533b\u7597\u8bbe\u5907\u7b26\u5408\u745e\u58eb\u6cd5\u89c4\u3002 \u4e3a\u4ec0\u4e48\u4f60\u9700\u8981\u745e\u58eb\u6388\u6743\u4ee3\u8868\uff1f \u745e\u58eb\u4e0d\u662f\u6b27\u6d32\u8054\u76df\u6210\u5458\u56fd\uff0c\u610f\u5473\u7740\u6b27\u76df\u6388\u6743\u4ee3\u8868\u5728\u745e\u58eb\u65e0\u6548\uff0c\u56e0\u6b64\u4f60\u9700\u8981\u745e\u58eb\u6388\u6743\u4ee3\u8868\u3002\u745e\u58eb\u6388\u6743\u4ee3\u8868\u8d1f\u8d23\u9075\u5b88\u745e\u58eb\u6cd5\u89c4\u548c\u6cd5\u5f8b\uff0c\u4e14\u5fc5\u987b\u57282022\u5e747\u670831\u65e5\u524d\u4efb\u547d\uff0c\u4ee5\u4fbf\u5df2\u7ecf\u5728\u745e\u58eb\u5e02\u573a\u4e0a\u7684I\u7c7b\u533b\u7597\u5668\u68b0\u80fd\u591f\u7ee7\u7eed\u5728\u90a3\u91cc\u7684\u5e02\u573a\u4e0a\u9500\u552e\u3002 \u56e0\u6b64\uff0c\u5728\u745e\u58eb\u6ca1\u6709\u6ce8\u518c\u529e\u4e8b\u5904\u7684\u533b\u7597\u5668\u68b0\u548cIVD\u5236\u9020\u5546\u73b0\u5728\u5fc5\u987b\u4efb\u547d\u5f53\u5730\u7684\u745e\u58eb\u6388\u6743\u4ee3\u8868\uff08CH-REP\uff09\u3002 \u81ea2021\u5e745\u670826\u65e5\u4ee5\u6765\uff0c\u5916\u56fd\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u5fc5\u987b\u4efb\u547d\u4e00\u540d\u745e\u58eb\u6388\u6743\u4ee3\u8868\uff0c\u624d\u80fd\u5c06\u5176\u4ea7\u54c1\u6295\u653e\u745e\u58eb\u5e02\u573a\u3002 CH-REP\u8fd8\u53ef\u4ee5\u83b7\u5f97\u6280\u672f\u6587\u4ef6\uff0c\u5e76\u4e14\u5fc5\u987b\u786e\u4fdd\u4ea7\u54c1\u7b26\u5408\u745e\u58eb\u836f\u54c1\u548c\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u673a\u6784\u7684\u8981\u6c42\u3002 \u6211\u4eec\u8fd8\u53ef\u4ee5\u5e2e\u52a9\u60a8\u627e\u5230\u5408\u9002\u7684\u9500\u552e\u5408\u4f5c\u4f19\u4f34\uff0c\u5728\u745e\u58eb\u5efa\u7acb\u9500\u552e\u7f51\u7edc,\u5e76\u4e3a\u60a8\u63a5\u7ba1\u745e\u58eb\u7684\u9500\u552e\u3002 \u6211\u4eec\u8fd8\u4e3a\u60a8\u7684\u4ea7\u54c1\u63d0\u4f9b\u670d\u52a1\u5408\u540c\uff0c\u4ee5\u786e\u4fdd\u60a8\u7684\u552e\u540e\u670d\u52a1\u6ee1\u8db3\u60a8\u7684\u9700\u6c42\u3002 \u6211\u4eec\u53ef\u4ee5\u66ff\u4f60\u63a5\u7ba1\u8fd9\u9879\u4efb\u52a1\u3002\u5982\u679c\u4f60\u611f\u5174\u8da3\uff0c\u53ef\u4ee5\u901a\u8fc7\u5fae\u4fe1\u6216\u9489\u9489\u4e0e\u6211\u4eec\u8054\u7cfb\u3002\u53ea\u9700\u626b\u63cf\u4e0b\u9762\u4e00\u4e2a\u7b80\u5355\u7684\u4e8c\u7ef4\u7801\u3002 \u5982\u679c\u60a8\u662f\uff1aIVD\u548c\/\u6216MD\u5236\u9020\u5546\uff1f \u4f4d\u4e8e\u745e\u58eb\u5883\u5916\uff1f \u5728\u745e\u58eb\u9500\u552e\u60a8\u7684\u4ea7\u54c1\uff1f \u60a8\u9700\u8981\u745e\u58eb\u6388\u6743\u4ee3\u8868\uff01 \u201c\u745e\u58eb\u533b\u7597\u5668\u68b0\u6388\u6743\u4ee3\u8868\u201d\/\u201cCH-REP\u201d\u662f\u6307\u5728\u745e\u58eb\u8bbe\u7acb\u7684\u81ea\u7136\u4eba\u6216\u6cd5\u4eba\uff0c\u53d7\u56fd\u5916\u5236\u9020\u5546\u4e66\u9762\u59d4\u6258\uff0c\u4ee3\u8868\u5176\u6267\u884c\u67d0\u4e9b\u4efb\u52a1\uff0c\u4ee5\u5c65\u884c\u672c\u6761\u4f8b\u89c4\u5b9a\u7684\u5236\u9020\u5546\u4e49\u52a1\u3002<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","footnotes":""},"class_list":{"0":"post-298","1":"page","2":"type-page","3":"status-publish","5":"entry"},"_links":{"self":[{"href":"https:\/\/stratos-swiss.com\/company\/index.php\/wp-json\/wp\/v2\/pages\/298","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stratos-swiss.com\/company\/index.php\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/stratos-swiss.com\/company\/index.php\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/stratos-swiss.com\/company\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/stratos-swiss.com\/company\/index.php\/wp-json\/wp\/v2\/comments?post=298"}],"version-history":[{"count":50,"href":"https:\/\/stratos-swiss.com\/company\/index.php\/wp-json\/wp\/v2\/pages\/298\/revisions"}],"predecessor-version":[{"id":476,"href":"https:\/\/stratos-swiss.com\/company\/index.php\/wp-json\/wp\/v2\/pages\/298\/revisions\/476"}],"wp:attachment":[{"href":"https:\/\/stratos-swiss.com\/company\/index.php\/wp-json\/wp\/v2\/media?parent=298"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}\n\n
\n ![\"WhatsApp](\"https:\/\/stratos-swiss.com\/company\/wp-content\/uploads\/2023\/09\/WhatsApp-QR-Code.png\")
\n![](\"https:\/\/stratos-swiss.com\/company\/wp-content\/uploads\/2023\/09\/Wechat-QR-Code-Stratos-Swiss-GmbH.png\")
<\/td>![](\"https:\/\/stratos-swiss.com\/company\/wp-content\/uploads\/2023\/09\/Ding-Talk-QR-Code-Stratos-Swiss-GmbH.png\")
\n<\/tr>\n<\/tbody>\n<\/table>\n\n\n\nSwiss authorised representative (CH-REP)<\/h1>\n\n\n\n
Why Would You Need A CH-REP?<\/h2>\n\n\n\n
If you are:<\/h5>\n\n\n\n
You need a Swiss Authorized Representative!<\/h5>\n\n\n\n
\n\n
\n \n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"excerpt":{"rendered":"