CONSULTING - INTERNATIONAL CERTIFICATE
Wonmed is a European CE (CE Marking) certification consulting organization and provides FDA registration, 510K product announcement, FDA PMA product announcement, 100% Korean owned company. Is a very long-standing certification consulting organization in Korea with a team of experienced international experts in the certification and evaluation industry of ISO, CE, FDA standards.
Present in Vietnam since 2019 with the goal of connecting and helping Vietnamese businesses understand standards, assist in the assessment and certification of CE standards as well as carry out FDA registration activities, contribute to completion of legal procedures. From there, it helps businesses easily export goods to the world's leading markets such as the EU or the United States.
Once mastered the global standards, the standards of product standards and at the same time the products are manufactured according to the highest standards such as CE or FDA. Then there are opportunities and raising the product quality of Vietnamese enterprises to a new level, firmly integrating into the global economy.
Won-Med was established in March 2013 in Guro-gu, Seoul, Republic of Korea. Wonmed has extensive partners throughout Japan, China, Southeast Asia and was present in Vietnam in February 2019. Won-Med provides many consulting services for international certification of ISO, CE Marking, CFS in the field. areas: medical equipment, food, cosmetics, health, construction, information technology, FDA registration, PMA product announcement or US FDA 510K product announcement.
Won-Med has a team of leading experts from Korea (average more than 15 years of experience) who will advise, advise and assist in completing procedures and documents to help businesses achieve their goals. CE or FDA certifications.
Especially, we are officially signed with CMC global. CMC MEDICAL DEVICES & DRUGS, S.L (CMC MEDICAL DEVICES & DRUGS, S.L) is a leading international consulting firm specializing in legal matters and focusing on medical devices. CMC's headquarters in Spain allows operations from Europe to the rest of the world, CMC has many representatives in many countries around the world.
CERTIFICATE SERVICES AND REPRESENTATIONS FOR THE MOST PRESTIGE ORGANIZATIONS.
EU REP - REPRESENTATIVE OF EUROPE
In the event that the manufacturer does not have a registered place of business in the European Community, the manufacturer shall appoint an Authorized Representative in the EU (EC REP) as required by Article 14.2* of the Directive Council 93/42/EEC as amended by Directive 2007/47/EC. CMC is an authorized EC REP with an office in Spain and CMC authorizes us Won-Med to exercise the same rights as an EC REP in Vietnam. The definition of an authorized representative in Regulation 765/2008/EC states that: “Authorized representative” on behalf of the manufacturer to perform specific duties related to the manufacturer’s obligations according to the relevant Community law.
Our duties as European Authorized Representative:
- Registers your devices with the national Competent Authorities before they are marketed, where applicable.
- Acts as your primary contact point for all national Competent Authorities.
- Maintains a current copy of your Technical File available for inspection by the European Competent Authorities.
- Gives you authorization to place our name and address on your device labels, packaging and Instructions for Use.
- Always available to interact between you and the national Competent Authorities.
- Responsible for Incident and Field Safety Corrective Action (FSCA) reporting to Competent Authorities, in cooperation with you and your distributors.
- Protects the confidentiality of your documentation. The European Authorized Representative can only show technical documentation to Competent Authorities as required by law.
- Monitoring changes to the regulations and communicate you only when is applicable.
- Represents you to the European Commission for consultation in case of withdrawal of a medical device by a Member State(s).
- Maintains reports concerning the critical evaluation of all data collected during clinical evaluations for review by Competent Authorities.
- Notifies or is notified by the Competent Authorities of serious device incidents or FSCA.
- Post-market surveillance.
UK RP - UK RESPONSABLE PERSON.
The transition period for the UK to leave the European Union ends on December 31, 2020. After this date, the UK will be considered a third country. It is implied that if you are a manufacturer outside of the UK, you need to designate a UK Responsible Person when your product is placed on the UK market.
We with extensive experience in EC Representative services have extended our customer support and responsible person service offering in the UK.
The responsible person in the UK will perform specific duties on behalf of the manufacturer in relation to the manufacturer's obligations. This includes registering a manufacturer's equipment with the MHRA before it can be placed on the UK Market. The UK responsible person will need to be listed on the product label.
All medical devices, including in vitro diagnostic medical devices, need to be registered on a new basis, however the MHRA has established different renewal periods depending on the product classification. For more information, please contact us.
CH REP - SWITZERLAND RESPONSABLE PERSON.
Switzerland is not part of the European Union, but historically very simple trading relationships with many bilateral treaties and agreements.
However, Switzerland and the EU have not renewed the mutual recognition agreement (MRA) governing products marked CE LABEL - ie CE Marking Certification. This has implications for medical devices. From 26 May 2021, European manufacturers wishing to bring their medical devices to the Swiss market must meet additional requirements: European manufacturers wishing to bring medical devices to the market Swiss schools must appoint an Authorized Representative located in Switzerland or CH-REP . Details of this representative in addition to the "CH-Rep" symbol must be indicated on the product label.
CMC and Won-Med have expanded our offices so that we can continue to support our customers in the Swiss market.
As CH-Rep, we will be the point of contact with the Swiss authorities (Swissmedic). We will perform specific duties on behalf of manufacturers in relation to their obligations. We use all of our expertise to guide them through the process.
Swiss regulations have given different deadlines for all parties to adapt to these changes.
We'll get you ready so you won't have any problems marketing your products in Switzerland.
FSC - FREE SALE CERTIFICATES.
The Free Sale Certificate, or FSC, is an international document used to export medical devices and IVD products. It indicates that your product is marketed in Europe and can be freely sold with no export restrictions.
The FSC is required to export medical devices and IVD products in certain countries. This document serves as proof that your goods meet European regulations and are eligible for export. This certificate is used in the registration or renewal of registration in non-European countries.
Not all FSCs have equal acceptance rates by the authorities in some importing countries. It is therefore important that your FSC is issued by a reference country. Spain is one of the so-called “reference countries” and all our certifications have always been accepted, providing new markets for our customers.
CE FOR MEDICAL DEVICES
We will guide you through the CE Certification route for medical and in vitro diagnostic devices under the new regulations (MDR 745/2017 & IVDR 746/2017) to get CE Marking on your devices.