Brazil ANVISA RDC 208/2018 Brazil ANVISA Resolution RDC 208/2018 (Medical) ANVISA ANVISA ANVISA RDC 208/2018 RDC 208/ NCM SUMMARY OF KEY POINTS

Size: px

Start display at page:

Download "Brazil ANVISA RDC 208/2018 Brazil ANVISA Resolution RDC 208/2018 (Medical) ANVISA ANVISA ANVISA RDC 208/2018 RDC 208/ NCM SUMMARY OF KEY POINTS"

诚问郝
5 years ago
Views:

1 NAVIGATION: Brazil Malaysia Saudi Arabia Japan Serbia EER Singapore India Telecom Product 國際市場准入資訊更新 Market Access News Updates Feb 2018 Newsletter

2 Brazil ANVISA RDC 208/2018 Brazil ANVISA Resolution RDC 208/2018 (Medical) ANVISA ANVISA ANVISA RDC 208/2018 RDC 208/ NCM SUMMARY OF KEY POINTS: A new ANVISA resolution has simplified medical device importation requirements for Brazil. Imported devices no longer have to undergo inspections at Brazilian points of entry. Additional changes to simplify ANVISA importation requirements are anticipated in the near future. Brazilian medical device market regulator ANVISA has simplified importation regulations to ease market entry for foreign manufacturers commercializing in the country. Among other changes, ANVISA Resolution RDC 208/2018 (link in Portuguese) removes requirements that devices imported into Brazil must undergo inspection at sites where they receive product clearance, which should result in faster time to market for affected importers. RDC 208/2018: IMPACT ON MEDICAL DEVICE IMPORTERS Other important changes in the new resolution include: Changing deadlines for responses to importation queries to 30 days Labeling requirements that now differentiate information according to product class Device imports no longer require authentication and signature recognition following implementation of electronic signing and petitioning processes Importers must no longer link MERCOSUR Common Nomenclature (NCM) to particular procedures

3 Japan PSE Japan-PSE Appendix 12 standard updated version performed from Dec 1, 2017 J , J , J , J , J , J , J , J , J , J , J , J , J , J55015, J55032 PSE H J , J , J , J , J , J , J , J , J , J , J , J , J , J55015, J55032 standard updated to version H29. The previous standard version will invalid from Nov 30, Singapore CPS Singapore - SPRING had announced the changes to the CPS regulation CPS A 2 CPSR 3 B C SPRING had announced the changes to the CPS regulation which take effective from 15 January Mains changes: 1) reduction in the product categories of Controlled Goods from 45 to 33 due to streamlined categories and removed obsolete products (see attached Annex A). 2) change of the scope for Controlled Goods regulated under CPSR to cover new products such as hair straighteners, styles, curlers, Lamp control gears etc. 3) implement of risk classification (low, medium and high) for controlled goods (see attached Annex B) and change of conformity assessment process (see attached Annex C) for low risk product. There is no changes to the conformity assessment process for medium and high risk product. For more information, please click here. For more information, please click here. For more information, please click here. TÜV 13 SS SS SS RCD SS 145 Part 2 BS IEC SS 403 TUV Rheinland (S) Pte Ltd extends certification scope covering plug and socket outlet as below: 3-pin Rectangular Type 13-Amperes plug: SS 145: Part 1 3-pin Portable Socket-Outlet: SS 145: Part 2 Multi-way Adaptor: SS pin 13-Amperes Socket-Outlet (Socket-Outlet with RCD): SS 145: Part 2, BS 7288 Domestic electric wall switch(13-amperes fused connection units switched): IEC , SS 403

4 Malaysia - SIRIM Malaysia-Secondary Battery SIRIM MS IEC 62133:2017 (IEC 62133:2012) / / SIRIM SIRIM KPDNKK / / The Secondary Battery Safety Compliance Guidelines are in force on 1 February The main purpose of this guideline is to guide industry on compliance with voluntary secondary safety standards. Any rechargeable battery will fall into the scope. Testing standard is MS IEC 62133:2017 (IEC 62133:2012). Test report from any accredited laboratory is acceptable. Importer/ trader / manufacturer must submit the application to SIRIM. All certified product must have SIRIM label. So far there are no regulation from KPDNKK to make it mandatory. However they urge all importer/ trader / manufacturer to get their product as soon as possible. Serbia EMC Serbia safety and EMC change from July 1, 2017 EMC LVD EMC EMC V 4. 3 Serbia new EMC and LVD Rulebooks have come into force in Serbia from July 1st. The biggest change is that certs are now valid for 5 years, previously it was three years. The only other change between old and new Rulebooks is the scope of EMC Rulebook. Pursuant to Article 10. of EMC Rulebook: The certificate of conformity will no longer be needed for the following devices: 1) apparatus supplied on the market without a battery charger or mains network adapter, powered by replaceable batteries or by connection to personal computer; 2) components of personal computers, other than power units; 3) machinery covered by specific legislation, other than transportable tools with electrical motors with alternating voltage up to 250 V intended for household or similar use; 4) for apparatus for which conformity assessment has been carried out in the Republic of Serbia in accordance with Annex 3 of this rulebook, regarding all aspects of essential requirement of this rulebook.

India - IS 16333 (Part 3): 2017 India -Guidelines for implementation of Revised IS 16333 (Part 3): 2017 / CENTRAL MARKS DEPARTMENT III IS 16333 Part 3 2016 IS 16333 Part 3 2017 IS 16333 Part 3 2016

5 India - IS (Part 3): 2017 India -Guidelines for implementation of Revised IS (Part 3): 2017 / CENTRAL MARKS DEPARTMENT III IS Part IS Part IS Part IS Part CENTRAL MARKS DEPARTMENT III has released the latest circular on the revision of the standard from IS (Part 3): 2016 to IS (Part 3): As per this new circular, IS (Part 3): 2016 has been revised as IS (Part 3): 2017 and has been published. The last date for implementation of the revised Standard is 29 May 2018 after which the old Standard shall stand withdrawn. For more information, please click here. Saudi Arabia G-Mark Saudi Arabia Mandatory Implementation of G-Mark (GCTS) for List 2 of LVE SASO GSO 2 G-mark GCTS GSO GSO 2 G-mark GCTS COC 1. GCTS GSO 2. G-mark 3. G-mark G-mark CoC CITC SASO has sent a notification to the registered CABs on the Strict Implementation of G-mark (the GSO Conformity Tracking Symbol (GCTS)) for Products falling into list 2 of the LVE Regulation. No CoC shall be issued for shipments that include Products in List 2 unless the GCTS is affixed on the Product itself and on the packaging. 1. Product itself and Packaging shall affixed with the GCTS (the GSO Conformity Tracking Symbol). 2. The G mark certificate must include a QR Code, Scan the QR Code and verify the authentication of the GCTS and the information extracted from the QR Code shall be compared vs. the actual product in the invoice. 3. In case PSI was performed, the inspectors shall use a QR Code reader (smart phones applications can be used) to verify the authentication of the GCTS and the information extracted from the QR Code shall be compared vs. the actual product. TÜV Rheiland provide one-stop service for product enter into Saudi Arabia market, including G-mark approval, Saudi Arabia CoC, Saudi Arabia Energy Efficiency registration and Telecom(CITC) approval.

EER News Update KSA: New addition to EER Program: Clothes dryers, Water heaters, Washing machines will be fall into EER scope. 2018 1 5 SASO - SASO 2883 25 SASO 2884 SASO 2885 25kg.

6 EER News Update KSA: New addition to EER Program: Clothes dryers, Water heaters, Washing machines will be fall into EER scope SASO - SASO SASO 2884 SASO kg Clothes dryers, Water heaters, Washing machines will be fall into EER scope. Electrical Clothes Dryers up to 25 Kg will be under EER. SASO has published the Standards SASO 2883:2017 for Electrical Clothes Dryers - Energy Performance Requirements and Labelling on January 5th,2018 as a mandatory Standard. Water Heaters (Electrical, Solar, and Gas Fired) will be under EER. SASO has published the Standards SASO 2884:2017 for Water Heaters Energy Performance Requirements and Labelling on January 5th,2018 as a mandatory Standard. New Energy and Water Performance requirement for Washing Machines up to 25 Kg. SASO has published the Standards SASO 2885:2017 for Washing Machines Energy Performance Requirements and Labelling on January 5th,2018 as a mandatory Standard. Starting from October 1st, 2018 will be the Implementation date at Border.

News Update for Telecom Product Argentina: New Cellular Standard & Local Testing ENACOM 5762-E/2017 ENACOM-Q2-61.03 V17.

7 News Update for Telecom Product Argentina: New Cellular Standard & Local Testing ENACOM 5762-E/2017 ENACOM-Q V ENACOM published Resolution 5762-E/2017, which includes new standard ENACOM-Q V17.1, for User Terminals of Services of Mobile Communications (cellular interfaces). Starting July 4th, 2018, cellular devices will require testing in local test labs. Until this date, new approvals and renewals may be submitted under the old resolution, using foreign certificates and test reports. ANTEL RF ATO 1448 Brazil ANATEL Publishes ATO for RF testing ANATEL MHz MHz; 10 LoRa ANATEL published Act which will complement the existing rule for RF testing in Brazil. A few of the changes brought by the act are described below: For wireless microphone, the frequency range of MHz was adjusted/changed to MHz; A test item inside item 10 was revised and this will help testing and approving devices with LoRa technology Mauritius New Telecommunication Directive ICTA PABX ETSI ICTA in Mauritius has updated the regulations governing type approval and addressing the requirements for licensed dealers in Mauritius. The updated regulation exempts certain BT and WiFi products and PABX systems from mandatory type approval. These newly exempted products are subject to market surveillance, and local dealers must hold compliance files (ETSI standards) on record.

4G/LTE Paraguay 4G/LTE band requirements CONATEL 4G CONATEL 700 MHz 4G/LTE LTE 28 4G/LTE 700 MHz 700MHz CONATEL Paraguay CONATEL confirmed a minimum set of requirements for Type Approval of devices

8 4G/LTE Paraguay 4G/LTE band requirements CONATEL 4G CONATEL 700 MHz 4G/LTE LTE 28 4G/LTE 700 MHz 700MHz CONATEL Paraguay CONATEL confirmed a minimum set of requirements for Type Approval of devices supporting 4G/LTE functionality. Below is a summary: CONATEL has confirmed that any device supporting 4G/LTE operation in the 700 MHz band must support LTE band 28. If a product supports 4G/LTE operation in the 700 MHz band but does not support LTE band 28, CONATEL has confirmed that they will be unable to homologate the device, unless the 4G/LTE function is disabled for Paraguay. Currently, there are no Paraguayan cellular network providers that offer services in 700 MHz; a spectrum auction is underway for 700 MHz and it is unknown which providers will end up offering the service. CONATEL also stated there is no official Regulation in place which outlines these requirements, and have not indicated when an official notification will be published. Nevertheless, they have confirmed that the minimum 4G/LTE requirements are effective immediately and apply to both new Type Approval applications and renewals. TÜV,, TÜV TÜV! TÜV Rheinland is one of the largest international certification bodies in the world. Our strong global service network provides our customers with one-stop-shop global market access. We are happy to announce our new "Market Access News Update," which TÜV Rheinland will release every two months. This update will allow our readers to gain awareness of and understand the latest certification requirements. TÜV Rheinland has specific rights reserved; any use of an article must be referenced back to the Source. Otherwise, this shall be regarded as copyright infringement.

LH_Series_Rev2014.pdf

LH_Series_Rev2014.pdf REMINDERS Product information in this catalog is as of October 2013. All of the contents specified herein are subject to change without notice due to technical improvements, etc. Therefore, please check