Aspects to consider when registering in the health registry

 Keep in mind that the activity of your business will determine whether or not you should apply to be included in the registry. FDA Registration India, you will have the responsibility to keep the health organizations up to date regarding any alteration in the physical address of your establishment or changes in ownership.

You must also notify the variations in the characteristics of your facilities or production systems, as well as the cessation of the activity of certain production lines (if applicable)

Depending on the characteristics of your establishment, there are various forms of registration in the health registry. Among these are:

–  Registration of products of animal origin: once the respective documentation is delivered, an inspector will verify that both the facilities and the processes comply with the defined protocols before the establishment can start its activity.

–  Registration of products of non-animal origin: by requesting the responsible declaration, the business may start its production even if it has not received the visit of the inspector. Then, if modifications are presented, they must be considered to continue operations.

–  Direct sale to the consumer: retailers (restaurants, bakeries, butchers, supermarkets, hotels, hospitals…) will also be able to start their activities by making a responsible declaration. Then, they will receive a visit from the health authority.

Benefits of enrolling in the health registry

Sanitary registration is a document that provides extensive benefits to companies. For example, it allows them to market their food products in all the member states of the European Union, and it is public, therefore, any of your clients can check the I3CGLOBAL website to corroborate the information.

In addition, it is important to avoid unexpected visits that could threaten the definitive closure of the establishment by not having this mandatory procedure.

Obtaining the sanitary registration is a necessary step so that your food company can carry out its production legally.

If you do not have the necessary requirements to obtain the sanitary registration or you need advice on food safety and how to carry out this procedure, it is best that you contact us so that we can help you and thus you can start the operations of your company in the shortest time possible in order to avoid serious penalties for a health inspection.

Read More:- FDA Registration India

European Authorized Representative – I3CGLOBAL

 

Selling consumer electronics and telecommunications products in Europe is expected to be more difficult in the near future due to the updating of the EMC LVD and RED (R & TTE) directives in accordance with the New Legislative Framework within the first six months of 2016.

The new legislative framework aims to improve market surveillance and improve the quality of conformity assessments, it also clarifies the use of the CE marking and creates a set of tools to be used in product legislation.

As a result of the experience gained after the application of the, which in 2011 was initially updated in line with the New Legislative Framework, we can say that economic operators have clearly perceived the new measures determined in particular by the high increase in activities of surveillance and consequent penalties imposed due to a high percentage of non-compliance that was found.

The retail chains, being explicitly involved in the directives, have implemented a series of supplier evaluation procedures to select the producers and importers who are able to ensure the correct application of the European directives.

International manufacturers have certainly established technical offices in Europe to handle the requirements of the directives, while some other manufacturers do not have the economic convenience to do so as most importers / distributors are not familiar with the complicated CE marking problems. It means that the economic operators involved need more skills to manage directives efficiently.

A European Authorized Representative acts as a technical / legal body designated by a non-EU manufacturer and represents them in the EU and acts on their behalf in carrying out certain tasks required by the New Approach directives. An authorized representative is not involved in the distribution or sale of the products.

The designation of I3CGLOBAL as an authorized representative of the EU: offers the manufacturer a point of contact in Europe;

Save the cost of opening a technical office in Europe;

Makes it easy to enter the EU market: only one authorized European technical representative such as the I3CGLOBAL is needed in all European countries to deal exclusively with the regulatory issues related to CE marking, while the manufacturer may have many importers, distributors and representative’s sales in Europe.

It reaches the new EU market. Importers, distributors and sales representatives will be easier to buy and sell. They don't need to deal with complex compliance issues and product certifications that require in-depth professional skills;

I3CGLOBAL acts as a contact point for market surveillance authorities and end users in case of compliance issues;

I3CGLOBAL stores and updates the technical files of the products sold in Europe and makes them available only to the competent authorities upon request;

I3CGLOBAL monitors and reports on new developments in European product legislation relevant to customers;

I3CGLOBAL assists with product recalls and issuing advisory notices. Get in touch.

Declaration of conformity and CE / EU marking

 Most industrial products require a CE MARKING to be marketed in the European Union, regardless of their country of origin. The CE Marking or CE Certificate of Conformity should not be confused with the Declaration of Conformity.

 

The CE Certificate of Conformity or CE Marking is the result of making a product comply with all the technical requirements demanded by each of the applicable directives (documentation, tests, and implementation of quality systems in some cases).

 

The EU declaration of conformity is a mandatory document that the manufacturer, or his authorized representative, must sign to declare that his products meet the requirements of the European Authorized Representative. 

 

By signing the declaration of conformity, the manufacturer assumes full responsibility for the compliance of its product with the applicable EU legislation.

 

It is part of the technical documentation that must accompany every product upon entering the EU. This technical documentation provides information on the design, manufacture, and operation of a product, and must include all the data necessary to demonstrate that the product conforms to the applicable requirements, in this case, within the EU.

 

If we are manufacturers and we intend to introduce our product in the EU, or if we are businessmen established in the EU, recipients of products from outside the EU, there are certain rules that we must know, in relation to these issues. 

 

In particular, the manufacturer must, and in the same sense, the recipient of its products must also require:

 

• prepare technical documentation before placing the product on the market.
• ensure that technical documentation (if they request to see it) is made available to market surveillance authorities as soon as the product is placed on the market.
• keep the technical documentation for ten years from the date the product is placed on the market (unless expressly specified otherwise).

 

Know more about declaration of conformity and templates

UK Regulatory Consulting Services by I3CGLOBAL

 I3CGLOBAL UK supports strategic regulatory affairs activities with high added value to more procedural activities aimed at obtaining authorizations quickly and efficiently, guaranteeing both the quality and safety of medicines throughout their life cycle.

Our experience and versatility in regulatory affairs allow us to offer our customers a service tailored to the situation of each client, making it an easy way for commercialization of the product, saving time and money.

We offer our regulatory affairs services such as fda dmf 510k, European Authorized Representative Services, Medical Device CE Marking, Clinical Evaluation & Reports, UKCA Mark and more at the European level is centralized, decentralized, and mutual recognition procedures, coordinating regulatory activities with all the different member states and Drug Master File agencies supported by our knowledge of the specific requirements and procedures of the different countries of the European Union.

Also, we support foreign companies at the national level, as their local contact to help with all procedures and activities of regulatory affairs.

CLINICAL TRIALS

I3CGLOBAL UK Regulatory Affairs team has the experience and flexibility to provide a reliable and adapted service to our clients to act as a local contact in the UK, managing all regulatory activities to obtain authorization for clinical trials.

During the regulatory affairs phase, it is crucial to have experience and knowledge of bottlenecks to avoid delays in authorization that may have an impact on the development of the clinical trial.

For this reason, we coordinate operations for our clients between the promoter and hospital centers, researchers, ethics committees. Offering an efficient regulatory affairs service by delivery times.

WHAT IS THE CE DECLARATION OF CONFORMITY?

 The Declaration of Conformity is the written document through which the manufacturer or its representative in the European Union declares that the marketed product complies with the essential requirements of the European Directives that apply to it. 

 

I3CGLOBAL GROUP, advises you on the procedure of drafting the Declaration of Conformity of your product correctly to be able to market it without problems in the European Union.

 

The Product Declaration of Conformity is part of the necessary documentation to be delivered to the customer or end-user of the product. This document details the harmonized standards that have been applied so that the product complies with everything provided by European regulations. 

 

It is important in the Declaration of Conformity that the intended use of the product is detailed as it exempts the manufacturer from any accident that occurs with its product in use in another area.

 

A written document by which the manufacturer or his representative established in the European Union declares that the marketed product satisfies all the essential requirements of the different application Directives. 

 

The signature of this document authorizes the affixing of the "CE" marking when so indicated by the Directive.

 

Data to be included in the Declaration of Conformity for CE Marking (see ISO / EN 17050)

 

• Name and address of the manufacturer or its representative established in the European Union.
• Description of the product (sufficiently detailed so that it is easy to identify the specimens covered by it: brand, model, etc.).
• Relevant provisions to which the product conforms (New Approach Directives).
• Reference to the harmonized standards used (it is also possible to include other standards or technical specifications that have been used).
• Name of the Notified Bodies that have intervened in the conformity assessment of the product.
• "CE" type certificate number / s, if required.
• In the case of an importer or marketer, the name and business name of the latter.
• Identification of the signatory (name, surname, and position).

 

To know more about the EU Declaration of Conformity kindly visit i3cglobal.com website.

 

 

 

FDA Authorization for Medical Device Manufacturers

 Manufacturers and importers of medical devices established in the European Union are finding more and more possibilities of exporting these products to third countries. Currently, the American countries are the ones that are showing the most interest in medical devices marketed in the European Union.

Indian companies searching distribution, import, and manufacture of sanitary products are finding great business opportunities exporting their sanitary products with CE markingto countries such as Chile, Mexico, Argentina, Venezuela, or Colombia since the export procedures are accepted with the European CE marking.

They are reduced to obtaining a certificate of free sale for medical devices once the communication of the placing on the market of class IIa, Class IIb, and Class III medical devices.

These free sale certificates are issued by some Chambers of Commerce.

For the export of medical devices to the United States, it is mandatory to register the product with the FDA (Food and drug administration), for this it is necessary to provide documentation similar to that needed to prepare the Technical File that is prepared to obtain the CE marking.

Depending on the product (class I, II, and III) the FDA will require prior authorization for its marketing (PMA, premarket approval) for class III medical devices that have a higher risk associated with their use and simply a prior notification to the marketing Premarket Notification, 510k.

Once the appropriate process has been carried out and the authorization by the FDA (Acceptance Review) has been obtained, the manufacturer must mark the product with the FDA marking, which demonstrates that the product is safe and effective for its intended use and can be exported to the United Stateswithout the need for a certificate of free sale.

To know more about FDA Registration and other regulatory services. Kindly visit the www.i3cglobal.com website

Biocompatibility Testing of Medical Devices – I3CGLOBAL

 When materials such as PVC began to be used, exposure to phthalates was a constant concern due to its harmful effects on health. These are plasticizing substances necessary to make plastic soft, widely used in the manufacture of sexual toys. 

Therefore, the health authorities have found it necessary to regulate these materials, however, some Asian countries use substances with the same properties but which are not regulated. 

Currently, several alternative plasticizers are available for medical applications. These include TOTM, DEHT, DINCH, and BTHC, all approved by the European Authorized Representative for medical applications. 

These new plasticizers allow healthcare professionals and patients to benefit from PVC's unique properties, such as softness, without the use of phthalates of interest.

The ISO 10993-1: 2018 standard establishes a guide on how to evaluate the Biocompatibility testing, this standard constitutes the standard in tests of this nature. The first part of this standard is the test selection guide, the second part includes animal welfare requirements, and the following sections cover specific test processes and other test-related issues.

The biocompatibility of medical devices is investigated using analytical chemistry, in vitro, and animal tests. The biocompatibility of a device depends mainly on the following factors:

• The chemical and physical structure of the component materials.
• Types of patient tissue to expose to the device.
• Exposure time to this device.

The biocompatibility assessment of a medical device is done to ensure patient safety and is necessary whenever the device is in contact with tissue. When scheduling a biocompatibility test, manufacturers must consider their compliance goals and risks. 

Know more at I3CGLOBAL.com, Biocompatibility Testing Main Page