www.wisecompany.org

Wise Co., Inc. is a young, enthusiastic, rapid extending, and fast growing regulatory consultation firm in South Korea.  

One thing we would like to let you know is, 

We know about medical device and cosmetic certification, registration, approval, whatsoever.  

We have considerable experience with U.S. FDA, CE (European), Russia (Customs Union), Thailand, and Korea.

Call us, email us, let us know what you are curious about.

Let us provide you our quotation with other detailed information that might save your time and money.

We have foreign customers who have never met us in person, but are satisfied with our service quality. We are willing and able to provide you proofs that we are entitled in doing what we are doing.

Besides, is consultation cost too high in your country?

Try Korean consultant. You know Koreans work hard.  

Business Area 

Medical Device

• CE MDD
• MFDS (Former KGMP)
• U.S. FDA (Except for PMA)
• China (Very difficult to foreign manufacturers around these days)
• Russia​

Cosmetic

• CPNP (European)
• ​U.S.FDA
• MFDS (Korea)
• Russia (Customs Union)
• TFDA (Thailand)
• China (Very difficult to foreign manufacturers around these days)
• Ukraine

Other services

• Responsible Person (CPNP, European Cosmetic)
• CE MDD (EC Representative)
• U.S. Agent (U.S. FDA medical Devices)
• Food (U.S. FDA)
• GUDID
• GMDN
• 2nd and 3rd party audit for QMS.
• Free Sales Cert

The post SOUTH KOREA appeared first on CE.way.

Taiwan and China Sinew Consulting Group is a Taiwan based company. They offers services in 4 different areas: sensory analysis, marketing, intellectual property (IP) management and regulatory compliance.

REGULATORY COMPLIANCE/REGISTRATION SERVICES

You will need to comply with the regulations for the market that you plan to get into.

SCG provides Regulation Services in Taiwan and Mainland China for the industries of Functional foods, Cosmetics, Personal cares, and Medical devices. The regulations are different in Taiwan and Mainland China as they are governed by different governments. The products in Taiwan will be regulated by TFDA as the ones in Mainland China will be regulated by CFDA.

Service Items :

• Cosmetics/Personal cares registration with TFDA
• Medical devices registration with TFDA
• Functional foods/Foods certification/approval with TFDA
• Cosmetics/Personal cares registration with CFDA
• Medical devices registration with CFDA
• Functional foods certification/approval with CFDA

Methodology :

1. Classify your products
2. Set up consignment relationship
3. Compile the product information documents
4. Experts review
5. Notification
6. Dialogue with officials
7. Registration/Approval

Advantages :

1. All compliance will be conducted by the experts in each category (Foods, Functional foods, Cosmetics, Personal cares, Agricultural Products, Medical devices).
2. All information documents will be controlled with SOP and kept confidential during the whole process.
3. Team members have expertise and plenty experiences to review necessary documents, properly suggest to the consigner, and properly dialogue with local officials.

We can help you to comply with the regulation as a team.

MARKET & INDUSTRY RESEARCH

You will need to learn the truth for the market that you plan to get into.

We will help you to find the truth.

SCG provides Market Research in Taiwan and Mainland China for the industries of Foods, Functional foods, Cosmetics, Personal cares, Agricultural Products, Medical devices.

Service Items :

• Industry environment & market analysis
• Consumer survey (tendency & behavior)
• Product concept survey (response)
• Competitor analysis
• Competence analysis

Methodology :

1. Questionnaire via e-system, email, post mail
2. Telephone interview
3. Face to Face interview

Charged Fee :

It will depend on the scope of the survey.

Advantages :

1. All survey will be conducted by the experts in each category (Foods, Functional foods, Cosmetics, Personal cares, Agricultural Products, Medical devices) compare to common market research companies.
2. All variables will be controlled with SOP during the whole survey conduction process, including the survey design, questionnaire design, target screening, data collection, and data management.
3. Data will be analyzed with proper statistical methods if needed.

We can help you to find the truth as a team.

The post TAIWAn and CHINA appeared first on CE.way.

www.drsaratal.com

Dr. Sara Tal has been engaged in the regulation and registration of cosmetic products in Israel since the year 2000. She has founded and managed the Israel Cosmetics Registration Department at Aminolab for over ten years. Several years ago, she started an independent business in the same field. She employs five people at her office in Rishon Le’Zion, who show skill, professionalism and seriousness and are fluent in Hebrew and English.

The Ministry of Health in Israel has been working on implementing a new regulation for cosmetic products; mainly switching from pre-market registration to in-market control, similar to the regulation in Europe since July 2013.

Once in place, Dr. Sara Tal will represent local manufacturers and importers and will act as your Responsible Person in Israel. The new law is planned to come into action at the latest at the end of the 3rd quarter of 2017.

The service includes:

• They make shore that the products that are marketed in Israel in compliance with all the regulatory requirements, as stated by the Ministry of Health, while making sure that the products are safe for use.
• Preparation of PIF (Product Information File) for each product according to the requirements of the Ministry of Health: production method, compiling information on raw materials, composition of formula, verification of no animal testing, marketing claim review, packaging and labeling of the product etc.
• Guidance for performing microbiological and chemical analyses, as well as stability and challenge test.
• Notification of products as required by the Ministry of Health and ensuring that the products of interest will be placed and circulated in the market without any problems.
• Keeping and updating the PIFs during the period that the products are in the market.
• Presentation of the PIFs to the Israeli Ministry of Health upon their request and reporting of undesirable effects.

The post ISRAEL appeared first on CE.way.

The following interview on cosmetic product claims was conducted as a part of a Datamonitor Consumer Project between Imogen Matthews and CE.way CEO Tadej Feregotto.

1. When working with clients, what steps do you take to ensure compliance of their cosmetic product claims?
First we review their labels and identify the claims that they’re making. We then check these claims to see if any of them are outside of the scope of the definition of cosmetic products, and therefore can’t be made for cosmetic products. Such are for example any claims that say that this product will heal a disease etc. We ask the client to remove those from the label, and provide proof for the remaining claims. We then check the proof provided by the clients, and evaluate whether it seems sufficient and if it supports the claims made on the label. If necessary we also consult with cosmetic claims experts outside of our company.

2. Are there product claims that brands can use without substantiation?
According to the cosmetics regulation, each claim has to be substantiated, except if the claim is a clear exaggeration, or a statement of an abstract nature. A popular example, that is also used in the regulation is “this perfume gives you wings”, other examples could be “you’ll have the most beautiful lips in the world”, “everybody will notice you”, or “you’ll love your new hairstyle”.
Also claims that are obvious don’t have to be substantiated. An example would be “lipstick colours your lips”.

3. Are there areas that are more relaxed so that a brand can come in with a “softer” claim?
Even though all of the claims have to be substantiated (except the ones listed previously), there are differences in the way they can or have to be substantiated and the level of substantiation needed. There are claims that are objective, such as “reduces wrinkles by 20% in a week” or “SPF 20”, which require “hard science” – experimental studies, to substantiate them; and there are more subjective claims, such as “your skin will feel softer” or “creates a wet look of your hair”, for which consumer perception tests would be more suitable. The latter are easier and cheaper to substantiate, and I guess that therefore you could say that they’re “softer”. Secondary claims that appear on the labels, which have no significant influence on consumer’s purchase decision, and are also not the first thing that you notice on a label would probably also consider to be softer claims. Claims which create a considerable competitive advantage or are important from health or safety aspects on the other hand, need to have a strong proof.

4. Which areas should be avoided as they are more likely to be challenged?
If you claimed that your product hasn’t been tested on animals, that used to be such a claim that was more likely to be challenged. However, this claim is now prohibited anyway due to the common criteria on claims (legal compliance), as it means that your product just complies with the minimum legal requirements in the EU, and therefore no cosmetic product placed on the EU market should have been tested on animals.
I can’t say for sure if there are any other areas that are more likely to be challenged, although I can imagine that claims that sound too good to be true are more likely to be challenged, as well as very specific claims, such as “increases the length of your eyelashes by 50% in 10 days” etc.

5. Why do brands get away with putting misleading cosmetic product claims?
Because of the lack of inspections, lack of knowledge, and because of the lack of clarity in the legislation. Obviously brands either aren’t punished for putting misleading claims on the products, or the punishments are not sufficiently high, and they more than cover for them by selling more products due to the claims made about their efficacy before they get caught.
There are also plenty of companies that just rebrand the products produced by someone else. Such companies often lack the knowledge in the legislation and science behind cosmetic products, and their cooperation with the producer in regards to which tests have been conducted and which claims can be sufficiently substantiated is vital.

6. Are there no checks?
Honestly, I don’t know. There probably are, but not that many. We haven’t heard of any or have ever been asked to provide proof for the claims that the companies we’re working with are making on their labels or in any other marketing materials. Safety of the products rather than their efficacy is probably the primary concern of the authorities.

7. What do you think should/can be done to overcome these problems about cosmetic product claims?
The problem is already in the vague legislation. Companies don’t even know what claims they can make for cosmetic products, or how to substantiate those that they’re making. Clarity in this field and education of the manufacturers would definitively help.
Besides penalizing the manufacturers that are putting misleading claims on the labels, their dishonesty should also be more widely advertised. A penalty is of course hurting them, but a loss of confidence of consumers in their products would be far worse. Of course such actions shouldn’t be taken for any minor claim that is not (sufficiently) substantiated, otherwise companies may become too afraid to put anything on the labels, and we would only have generic products on the market.
Perhaps even a list of claims that are allowed together with specific tests which have to be done to substantiate them would help. This would definitively simplify matters for everyone involved, but I acknowledge that on the other hand this may inhibit further development and creativity when creating new products.
Another thing that could be done, but which would also require a substantial increase in the personnel employed by the Commission or the competent authorities, would be to check the product information files – including labels, claims and their substantiation, by the authorities before the products can be placed on the market, thereby introducing a registration instead of the notification, and not counting on the responsibility of the manufacturers that they’ll do everything according to law on their own initiative.

The post Cosmetic product claims interview for Datamonitor appeared first on CE.way.

Cosmetics manufacturers that want to start selling their cosmetic products on the EU market need to follow these 5 steps in order to be able to do so:

1. Classify your products

Manufacturers firstly need to determine if their products are indeed cosmetic products or not. Product classification may not be as obvious as it may seem. Certain products that would be classified as cosmetics in other parts of the world could be classified as biocides, medical devices, pharmaceuticals, toys etc. in the EU. Classification often depends on the product’s claims.

In the EU cosmetic products are defined as: ‘cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours. (EU Regulation 1223/2009, Article 2.1.a).

2. Assign the Responsible person

Each product placed on the EU market needs to have a Responsible person assigned. Responsible person needs to be based in the EU, so if the manufacturer is based outside of the EU, then he needs to appoint a company in the EU to act as the Responsible person for his products placed on the EU market. The assigned Responsible person can either be the distributor, importer, a professional Responsible person or any other third company or person. There has to be only one Responsible person assigned per product for the whole EU.
Only cosmetic products for which a legal or natural person is designated within the Community as ‘responsible person’ shall be placed on the market. (EU Regulation 1223/2009, Article 4.1).
In order to establish clear responsibilities, each cosmetic product should be linked to a responsible person established within the Community. (EU Regulation 1223/2009).

3. Compile the Product Information File

Before cosmetic products are placed on the EU market, they need to have a Product Information File (PIF) compiled. Product Information File has to be kept by the Responsible person, and it contains a number of different raw material, finished product, packaging etc. specifications and test described in the Article 11 and Annex I of the EU cosmetics regulation compliant.

4. EU notification to the CPNP portal

Responsible person has to notify the cosmetic products to the EU CPNP portal before they’re placed on the market.
Prior to placing the cosmetic product on the market the responsible person shall submit, by electronic means, the following information to the Commission… (EU Regulation 1223/2009, Article 13.1)

5. Enter the EU market and maintain your products compliant with the EU cosmetics Regulation

After these 4 steps are done, manufacturers can start selling their products on the EU market. They must keep in mind though, that their cosmetic products must always remain compliant with the EU cosmetics Regulation, and that any changes made to the product must be reflected in the Product Information File.

EU cosmetics regulation compliant:

The post 5 steps to becoming compliant with the EU cosmetics regulation appeared first on CE.way.

An important amendment of the Annexes II and V of the EU cosmetics Regulation 1223/2009 was published in April.

The most important changes to the Regulation are the following:

–          Isopropylparaben, Isobutylparaben, phenylparaben, benzylparaben, pentylparaben can no longer be used in cosmetic products

–          Measures on propylparaben and butylparaben are under preparation

–          Triclosan is banned in certain products, restricted to 0.3% in toothpastes, hand soaps, body soaps/shower gels, deodorants (non-spray), face powders and blemish concealers, nail products for cleaning the fingernails and toenails before the application of artificial nail systems; and restricted to 0.2% in mouthwash products

–          Entry 12 of Annex V to Regulation (EC) No 1223/2009 specifies a maximum concentration of 0,4 % for single ester and 0,8 % for mixtures of esters in relation to the use of parabens as preservatives in cosmetic products, under the denomination 4-hydroxybenzoic acid and its salts and esters.

–          The application of the above-mentioned restrictions should be deferred to allow the industry to make the necessary adjustments to product formulations. In particular, undertakings should be granted six months to place on the market compliant products, and 15 months to stop making available on the market non-compliant products after the entry into force of this Regulation, in order to allow existing stocks to be exhausted

The post 5 parabens banned, certain other ingredients restricted appeared first on CE.way.