Export of medical equipment to Europe.
What medical equipment and personal protective equipment do you need to have a CE certificate to be eligible for export to the European market? What is the process, procedure, and cost to get the COR certificate? How to authenticate and which reputable units are eligible for certification related to CE... are questions asked by many manufacturers and exporters in this field.
The complicated Covid-19 pandemic in Europe and America has forced many countries in these regions to step up the import of masks and medical protective equipment, however, for these products to be imported. Importing is required to meet a lot of complicated standards and procedures.
In export activities and procedures, enterprises often face difficulties and embarrassment in meeting the standards and quality of the importing country, especially the EU CE Marking certification process.
Those difficult issues include the outstanding ones:
- The related goods need to be registered or certified, the regulations apply to each specific product line to be eligible for export to the EU.
- Process, procedures, time, cost, validity period of registration and certification (CE marking) for each specific product line.
- CE certification authentication method; units and laboratories that meet the legal standards prescribed by the European Commission.
Won-Med VINA is a CE Marking certification organization with deep knowledge in the medical device field, and with a team of industry experts who understand the laws and standards of Europe and America. Will provide support for medical equipment manufacturers and businesses that are eligible to export to the US and European markets.
To ensure long-term development, enterprises need to invest in professional production according to standards, according to the quality management system, to meet the technical standards of the main export markets. especially the European market, not only for personal protective equipment and medical equipment, but also for products with export strengths, taking advantage of the advantages when the EVFTA agreement officially takes effect.
What are the import conditions of the European market for the goods of the exporter so that they can be prepared to meet in addition to ISO 13485 certification.
On the Vietnamese side, please note Articles 40 and 41 of Decree 36/2016/ND-CP (amended and supplemented by Article 1 of Decree 169/2018/ND-CP):
Article 40. Principles of management of export and import of medical equipment.
1. Organizations and individuals that export or import medical equipment must satisfy the conditions prescribed by the law on export and import and must take responsibility for ensuring the quality of the medical equipment. medical equipment that they export or import.
2. Medical equipment with a free-sale registration number in Vietnam may be exported or imported according to demand, without quantity limitation and without the approval of the Ministry of Health, except medical equipment containing narcotic substances. drugs and precursors.
3. The issuance of a certificate of free sale only applies to exported medical equipment according to the Prime Minister's regulations.
Article 41. Export and import of medical equipment.
1. To encourage domestic enterprises to produce for export.
2. The order and procedures for exporting and importing medical equipment must comply with the provisions of law on customs. Organizations importing medical equipment are not required to prove the satisfaction of the conditions specified in Clause 2 of this Article when carrying out customs procedures.
For medical device manufacturers, in order for their products to be circulated on the domestic market, they must first have the ISO 13485 certification accompanying the manufactured medical device.
The next step is to export to the domestic market, specifically here to the European market, enterprises need to determine what are the requirements of the importer?
If the importing party (Europe) requires medical equipment with ISO 13485 standard, the enterprise only needs to provide proof from the NCC side.
And if required from the business, it must be done. For CE Mark, it is a mandatory requirement for medical equipment on the European side, so it is imperative that businesses do this certification before exporting to Europe.
WONMED VINA CO., LTD
Office in VietNam: P7-43.OT09, Park 7, Vinhomes Central Park, 720A Dien Bien Phu Street, Binh Thanh Dist, Ho Chi Minh City.
Tel: 028 3620 6200 - Hotline: 0325269326
Email: [email protected]
Won-Med is a European standard CE Marking organization, ISO 13485 certified. Accompanying and supporting all Vietnamese businesses step by step to raise their brand and product quality. Reaching the highest standards of the most developed markets in the world such as Europe and the United States. Since then, affirming the position for Vietnamese products with quality comparable to those of global manufacturers, opening up export opportunities to the whole world.