Certification Test Expert

EU Medical Device Regulation Significant changes ahead for medical device manufacturers Medical device manufacturers will soon be confronted with major changes in the EU’s decades-old regulatory framework which governs market access to the European Union (EU). A new medical device regulation (MDR) is making its way through final tri-party negotiations between the EU Commission, the European Council and the European Parliament. Once final approval is achieved, the MDR will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC). The proposed MDR differs in several important ways from the EU’s current directives for medical devices and active implantable medical devices. The most significant changes in the proposed regulation include: Key changes    Product scope expansion  - The definition of medical devices and active implantable medical devices covered under the MDR...

개인보호용품 새지침 발효 New European Regulation (EU) 2016/425 Thursday 11th May 2017 On March 31st 2016, the European Commission published new Personal Protective Equipment (PPE) legislation as Regulation (EU) 2016/425. This will replace the current PPE Directive 89/686/EEC which has required all PPE placed on the European market since 30th June 1995 to be CE marked. During the last 22 years, hundreds of thousands of models of PPE have gone through the certification process under the current PPE Directive and millions of individual products have subsequently been CE marked and sold all across Europe. However, to continue placing these products on the market they will have to be certified to the new Regulation and after 21st April 2019 it will be illegal to place on the market any item of PPE that has not been certified to the new Regulation. The scale of this recertification task is potentially enormous and will require careful planning and managing to ensure a smooth transition and to m...

ECAS   registration of   Oxo-Biodegradable Plastic Products .  Application is done per Brand and per product category and per intended use. 플라스틱으로 만들어지는 모든 제품류 - 모든 캐리어 백 All Carrier Bags (including shopping bags, garbage bags, garment bags, and any disposable bags). - 택배가방 Courier and Security bags. - 우편가방 Mail Order Bags (Magazine and Newspaper Bags) - 일회용 식기류 Disposable Cutlery such as plastic plate and plastic cups - 비닐포장재 Bubble Wrap and Cushioning Packaging - 꼭 포장재 Flower Wrap - 포장재 Overwrap Packaging - 스트레치 필름 Stretch Film -  (특히 식품 포장용 비닐) 랩  Cling Film - 수축 필름 Shrink Film - Plastic Liners for Cartons - 개인용 도구류 등 Personal Care products made of plastic materials such as gloves, shoe covers, aprons and any disposable personal care products - 플라스틱 백 Plastic bags for seedlings - 폴리에틸렌 시트 Polyethylene Sheets on Rolls such as table covers - 식품용 백 Bags for packaging Bread, nuts, sweets and all bakery items 다음의 자가체크 리스트...

GCC   Gulf Cooperation Council  Mark for toys and Low Voltage Electrical Equipment products. we would like to emphasize about the previous Announcements that regarding of the mandatory application of G-Mark for the products covered   by the "GCC Technical regulation on children toys" and " Gulf Technical Regulation for Low Voltage Electrical Equipment and Appliances" we would like to inform and emphasize that this products should carry G-Mark according to the conformity marking regulation for the GCC countries. conformity marking regulation ( Arabic copy ) official. https://www.gso.org.sa/gso-website/gso-website/activities-ar/conformity/technical-regulations-and-guides /شاره-المطابقه- bd09100501.pdf conformity marking regulation ( English copy ) not official. https://www.gso.org.sa/gso-website/gso-website/activities/conformity/technical-regulations-and-guides/gcc-tr-on-marking.pdf take note the products that carry G-mark are E...

SASO ISO 13006:2016, Ceramic tiles -- Definitions, classification, characteristics and marking We would like to remind you that  SASO's Board of Directors issued Standard(Technical Regulation)  SASO ISO 13006:2016, Ceramic tiles -- Definitions, classification, characteristics and marking ,  this Standard has been published in the Official Gazette on 27/08/1437(3 June 2016).  The mandatory application stage, will be after six months from the date of publishing in the official Gazette (i.e. 28/02/1438H) corresponding (28 November 2016). Therefore SASO confirm the need to emphasize the commitment to the requirements of this standard for issuance the CoC for Ceramic tiles to be exported to Saudi Arabia. You could reach to this  Mandatory  Standard  through the link :  https://wasifs.saso.gov.sa/Pages/User/Default.aspx

Dear CB We would like to inform you that SASO has received numerous reports from related  regulatory authorities  about the fire hazards as a result of liquefied petroleum gas (LPG) due to non-conformity of  Pressure regulators  to related SASO standards. Therefore SASO confirm the need to emphasize the commitment to the requirements of the relevant standard, special requirements relating to the safety,  in carrying out  certification procedures, for  Pressure regulators of   gas, to be exported to Saudi Arabia, according to SASO EN 16129  Note that SASO issued a "Technical Regulations for gas appliances and accessories" that published in the Official Gazette on 27/08/1437.  The mandatory application stage, will be after six months from the date of publishing in the official Gazette. You could reach to this technical regulation through the link : http://www.saso.gov.sa/en/conformity/Technical_regulations/Pages/Regulati...

With reference to recognition program, Please find attached clarification   for understanding  SASO 2663:2014 , concerning with energy labeling and minimum energy performance requirements for Air-Conditioners (Clause 4&5), a s shown in the attached file. So it shall be noted