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4. Product Certification Consultancy

4.1. CE Mark

The Certificate of Conformity Europe (CE Mark) is a mark to indicate that the product to which it is affixed is in conformance with EU Product Safety Directives. These EU Directives apply to all products that are to be put into service for the first time inside the European Economic Area.

 

The CE marking indicates a product’s compliance with EU legislation and so enables the free movement of products within the European market. By affixing the CE marking to a product, a manufacturer declares, on his sole responsibility, that the product meets all the legal requirements for the CE marking, which means that the product can be sold throughout the European Economic Area (EEA, the 28 Member States of the EU and European Free Trade Association (EFTA) countries Iceland, Norway, Liechtenstein). This also applies to products made in other countries which are sold in the EEA.

However, not all products must bear the CE marking, only product categories mentioned in specific EU directives on the CE marking.

 

CE marking does not indicate that a product was made in the EEA, but merely states that the product has been assessed before being placed on the market and thus satisfies the applicable legislative requirements (e.g. a harmonized level of safety) enabling it to be sold there. It means that the manufacturer has:

verified that the product complies with all relevant essential requirements (e.g. health and safety or environmental requirements) laid down in the applicable directive(s) and

if stipulated in the directive(s), had it examined by an independent conformity assessment body.

 

It is the manufacturer’s responsibility to carry out the conformity assessment, to set up the technical file, to issue the declaration of conformity and to affix the CE marking to a product. Distributors must check that the product bears the CE marking and that the requisite supporting documentation is in order. If the product is being imported from outside the EEA, the importer has to verify that the manufacturer has undertaken the necessary steps and that the documentation is available upon request.

 

 

Benefits of CE Marking Certification:

There are a significant number of advantages of CE marking for the manufacturer and for the consumer. In particular:

  • CE marking provides manufacturers with market access to the whole European Economic Area, since countries within this area may not restrict the placing on the market of products bearing the CE marking.
  • It guarantees that the product conforms to the regulations in the specific directive
  • It is a guarantee for the manufacturer that the product is safe for consumers
  • It may significantly reduce damage claims and liability premiums.

4.2. SASO Mark

The Kingdom of Saudi Arabia requires that all consignments of products to be exported to the country should be accompanied by a Certificate of Conformity (CoC).

The Saudi Arabian Conformity Assessment Programme (CAP) is a strict set of guidelines implemented by The Saudi Standards, Metrology and Quality Organization (SASO).

It provides pre-shipment verification of conformity to standards required by Saudi customs officials and verifies that products being imported into the Kingdom of Saudi Arabia conform with applicable safety, quality and technical regulations and standards before shipment.  Standards relating to the Islamic Religion and National culture are also given priority.

The SASO Certificate of Conformity (CoC) is a mandatory document used by Saudi Customs Services for clearance of goods going to Saudi borders and ports.

(Reference : https://www.xds-solutions.com/saso/#)

 

The Saudi Standards, Metrology and Quality Organization (SASO) Certificate of Conformity (CoC) scheme ensures that all products entering into Saudi Arabia are in conformity with national product safety and quality requirements.

Importers require SASO conformity certification at customs to prove product conformity and to clear the shipment from the port. The scheme applies to all types of products, excluding a small scope of non-regulated products.

(Reference : http://www.racs-me.com/saudi-quality-mark/saso-certificate-of-conformity/)

 

Benefits of Saudi Quality Mark:

  • It inspires the continuous development and improvement of the product by following modern scientific methods that improve the product.
  • This enrich competitiveness in international markets.
  • It enhances the reputation and name of establishments locally, regionally and internationally.
  • It facilitates the entry of products through customs ports.
  • It facilitates the export process of the products carrying it.
  • It increases merchant’s sales.
  • It is a way of constructing conventional trade infrastructures that facilitate signing export contracts with other countries.
  • It qualifies establishments to win local and international quality awards.
  • It supports the national economy, increases competitiveness of Saudi products in the local and international markets and increases Saudi exports.
  • The Quality Mark is an important means to guide consumers to products that conform to Saudi standards.
  • Through the Quality Mark, products gain customers satisfaction and trust.

4.3. ESMA Mark

Emirates Authority for Standardization and Metrology (ESMA) is implementing the Emirates Conformity Assessment Scheme (ECAS) and the Emirates Quality Mark (EQM). Under this scheme, local and imported products are verified for compliance against National Standards.

ESMA has established Technical Committees in the fields of food products, construction and building materials products, electrical and electronic products, chemical and plastic products, mechanical products, petroleum products and lubricants, and metrology and information technology.

 

Emirates Conformity Assessment Scheme (ECAS)

ECAS is a Product Certification scheme for government-regulated products as mandated by the Federal Law 28 of 2001.

Under this scheme, all regulated products must meet the requirements for safety and quality specified in the Technical Regulations adopted by the UAE government.

Suppliers must register the products and obtain Certificate of Conformity prior in order to sell inside the UAE.

  • A proof that the product has been approved by the Federal Government through ESMA.
  • One of the documents required when clearing shipments from Ports and Customs Authorities.

Emirates Quality Mark:

The (EQM) is a mark of conformity granted to the products that can demonstrate compliance with the relevant UAE National Standards, Regional and/or International Standards and are manufactured by an organization implementing an effective Quality Management System to ensure continuous compliance.

The process of achieving the license to use the Emirates Quality Mark involves a comprehensive evaluation of the product as well as the quality system used by the manufacturer in production through auditing, testing and inspection.

  • Issuance of License to use Emirates Quality mark for Products and factories According to the technical requirements of Board of director’s decision.
  • The EQM Certificate can be used to clear shipments from Ports and Customs Authorities instead of ECAS Certificate for the certified products only.
  • The Mark can be printed on the certified product as a proof of compliance and approval by the Federal Government through ESMA.

4.4. FDA Registration

Food & Drug Administration (FDA) Registration is the basic requirement for domestic and foreign establishments that manufacture or market food, drug, API or medical device in the USA. FDA registration is not mandatory for cosmetic establishments but can participate in FDA voluntary cosmetic registration program (VCRP).

Reference : https://www.fdahelp.us/, https://www.fda.gov/industry/fda-basics-industry, https://giannamore-law.com/our-services/fda-consultant/ , https://www.registrarcorp.com/)