Certifications

Certifications

The certificates are divided into two categories, one is the medical products we support to sell these certificates, and the other is the customs clearance certificates that customers need to handle.

1. Product medical industry certificate
CE, ISO, FDA, KFDA, PMDA, ANVISA, CMDCAS, TFDA, GMP, CFS, TGA, and BSCI are all certificates required by the medical industry. If necessary, you can filter the certificate yourself.

1)CE certification
CE certification that is, only the product does not endanger the basic safety requirements of human, animal and goods safety, rather than the general quality requirements. The coordination directive only specifies the main requirements, and the general instruction requirements are standard tasks. Therefore, the exact meaning is that the CE mark is a safety pass mark and not a quality pass mark. It is the "main requirement" that constitutes the core of the European Directive.

2)ISO Certificate 
The full name of ISO is International Organization for Standardization, translated into English is the "International Organization for Standardization.

3)FDA Certificate
The FDA is one of the executive agencies established by the US government in the Department of Health and Human Services (DHHS) and the Department of Public Health (PHS). As a scientific regulatory agency, FDA's role is to ensure the safety of food, cosmetics, pharmaceuticals, biologics, medical devices, and radioactive products produced or imported in the United States. It was one of the first federal agencies to protect consumers as its primary function.

4)KFDA Certificate
certification refers to the domestic product production and sales license issued by the Korea Food and Drug Administration (KFDA)

5)PMDA Certificate
PMDA is an independent administrative agency in Japan. Its main responsibility is to assist the Japanese Ministry of Health, Labour and Welfare (Health Bureau) in ensuring the safety, efficacy and treatment of pharmaceuticals and medical equipment.

6)ANVISA Certificate
ANVISA, part of the Brazilian Ministry of Health, is responsible for pre-market approval and post-marketing supervision of all medical devices, in vitro diagnostic products and other health-related products.

7)CMDCAS Certificate
CMDCAS is a Canadian-approved third-party organization and all medical devices that enter the Canadian market are subject to approval by Health Canada.

8)TFDA Certificate
TFDA is accredited by accredited laboratories.

9)GMP Certificate
GMP is the abbreviation of English GOOD MANUFACTURING PRACTICE, meaning "good manufacturing practice". The World Health Organization defines GMP as a regulation that governs the production and quality management of food, medicine, and medical products.

10)CFS Certificate
The Certificate of Free Sale refers to a document issued by the competent authority of an EU country that certifies that a medical product can be sold freely in a specific area, referred to as CFS.

11)TGA Certificate
Administration (TGA) is the federal drug authority affiliated with the Australian Ministry of Health.

12)BSCI Certificate
BSCI (Commercial Social Standards Certification) - The full name of Business Social Compliance Initiative, BSCI is the initiative of the Business Compliance Social Responsibility Organization. The Business Compliance Organization ("BSCI") aims to implement a unified set of procedures to monitor and control through continuous improvement of development policies. And the social responsibility performance of companies that promote the production of related products.

2. Customs clearance certificate required by the customer

1)CO certificate
General Certificate of Origin, referred to as CO certificate. The certificate is based on the "Regulations on the Origin of Import and Export Goods. Certificate of Origin issued for export goods.

2)FORM A certificate
There are 39 countries that have given GSP treatment: Britain, France, Germany, Italy, Netherlands, Luxembourg, Belgium, Ireland, Denmark, Greece, Spain, Portugal, Austria, Sweden, Finland, Poland, Hungary, Czech Republic, Slovakia, Slovenia, Estonia, Latvia, Lithuania, Cyprus, Malta, Bulgaria, Romania, Switzerland, Liechtenstein, Norway, Russia, Belarus, Ukraine, Kazakhstan, Japan, Australia, New Zealand, Canada, Turkey, United States (except the United States, others 39 countries have given GSP treatment)

3)FORM B certificate
The members of the Asia-Pacific Trade Agreement are: Bangladesh, India, Laos, South Korea and Sri Lanka.

4)FORM E certificate
ASEAN member countries are: Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam.

5)FORM P certificate
The Pakistan Free Trade Area Certificate of Origin is a legally binding official documentary evidence of the reciprocal reduction of tariffs for specific products between the member states of the Agreement, as required by the Agreement on the Early Harvest Program of the Pakistan Free Trade Agreement. The visa is based on the Pakistan Free Trade Zone Rules of Origin and its Visa Operating Procedures.

6)FORM F certificate
The Chile Free Trade Zone Certificate of Origin is a legally binding official document issued by the Chile Free Trade Agreement that enjoys reciprocal tariff reductions for specific products between the member states of the agreement. The visa is based on Chile Free Trade Zone Rules of Origin and its Visa Operating Procedures.

7)FORM N certificate 
On April 7, 2008, the "Free Trade Agreement between the Government of the New Zealand Government" was officially signed under the witness of the two prime ministers. This is the first free trade agreement signed between  developed countries. Since October 1, 2008, various entry-exit inspection and quarantine agencies have issued certificates of preferential origin of the New Zealand Free Trade Zone.

8)FORM X certificate 
Since January 1, 2009, various entry-exit inspection and quarantine agencies have begun to issue Singapore Free Trade Zone preferential certificate of origin.

9)Form S certificate
Swiss Free Trade Agreement Certificate of Origin (Form S). The Free Trade Agreement between the Swiss Confederation was implemented on July 1, 2014.

10)Free Trade Agreement
The FTA is a free trade agreement between Australia that is under negotiation. Referred to as the Australia Free Trade Agreement.

11)Free Trade Agreement
On December 9, 2015, Vice Foreign Minister Wang Shouwen exchanged a diplomatic note with South Korean Ambassador to South Korea jointly confirmed that the Free Trade Agreement between  the Republic of Korea will come into effect on December 20, 2015. The first tax reduction, the second tax reduction on January 1, 2016. The South Korea Free Trade Agreement has finally taken root.