What certifications and information are required to import medical plastic products into the United

Starting from FDA certification, you will gradually find the doorway.

It belongs to the food contact category and needs to be certified by FDA.

Well, just do an FDA test, we are a testing and certification company, you can do FDA testing, you need to find, the information has information.

CE definitely wants it, and then it depends on what kind of product you are, and what is the HS code.

Take a look at the regulatory conditions.

It mainly depends on what kind of product you have, medical devices must be FDA, because the product is exported to the United States, and CE is usually not needed as a barrier to EU import and export. msn：

Is it brand new? In general, the following information is required:

Equipment's **, nameplate, equipment technical parameters, end use, Chinese instructions, etc., import medical equipment registration certificate and business license, some equipment requires automatic import license (o certificate), packing list, invoice, contract, bill of lading,

It is estimated that foreign suppliers do not have foreign supplier AQSIQ registration certificate and CCIC certification, because the following materials need to be provided to apply for foreign supplier AQSIQ registration certificate;

Application for registration.

Notarized tax registration documents, if there are business registration documents, also need to provide notarized business registration documents, a description of the organization, department and job responsibilities.

Color copies of ISO9001 quality management system or RIOS system and other certification certificates and related work instruction documents.

The submitted written materials must be in Chinese or Chinese and English.

It is estimated that the other party does not have aqsiq

I can come out of CCIC if needed

Yes. Different countries have different product certification requirements. Passing the FDA can only be said to meet the food safety level requirements of the United States, but China has China's product quality requirements, and QS certification is still required.

FDA is the abbreviation of Food and Drug Administration (Food and Drug Administration). FDA sometimes stands for the U.S. FDA, that is, the U.S. Food and Drug Administration, the U.S. FDA is the international medical review authority, authorized by the U.S. Congress, that is, the federal **, the highest law enforcement agency specializing in food and drug administration; It is a monitoring body composed of professionals such as doctors, lawyers, microbiologists, pharmacologists, chemists and statisticians dedicated to protecting, promoting and improving the health of the people. Many other countries seek and receive help from the FDA to promote and monitor the safety of their products.

According to the Announcement of the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China on Matters Concerning the Use of Enterprise Food Production License Marks (Announcement No. 34 of 2010 of the General Administration of Quality Supervision, Inspection and Quarantine), the enterprise food production license mark is indicated by the abbreviation "QS" of the pinyin "qiyeshipin shengchanxuke" of "enterprise food production license", and is marked with the Chinese word "production license".

Sales in China should also be GMP certified in China.

FDA CertificationFDA's role is to ensure the safety of food, cosmetics, drugs, biologics, medical devices, and radiological products manufactured or imported in the United States. This certification has the highest usage rate. Applicable Products:

Medications, food (all utensils), medical equipment (glasses, knee pads), toys, etc.

DOT CertificationThe DOT certification system is the Federal Motor Vehicle Safety Standard (FMVSS). DOT certification is mandatory, that is, all motor vehicles and accessories sold in the United States must pass DOT certification and have the DOT mark. Applicable Products:

Motor vehicle and spare parts products, auto lights, auto parts, etc.

UL certification UL certification is a non-mandatory certification in the United States, mainly for the testing and certification of product safety performance, and its certification scope does not include the EMC (electromagnetic compatibility) characteristics of the product. If a consumer buys a product with the UL mark and has adverse consequences due to product quality problems, the consumer can complain to the seller, and the seller can easily get compensation from the insurance company. The certification cycle is usually about 2 months.

Applicable products: lamps, household appliances, communications, power tools, wires and cables, etc. FCC Certification: FCC stands for Federal Communications Commission.

The FCC coordinates domestic and international communications by controlling radio broadcasting, television, telecommunications, satellites, and cables. It involves more than 50 states in the United States, Colombia and the United States to ensure the safety of radio and wire communication products related to life and property. Many radio applications, communications and digital products require FCC approval to enter the U.S. market.

Applicable products: electronic products, such as computers and computer accessories, household appliances, power tools, lamps, toys, security, etc. The CE mark is a safety certification mark that is regarded as a passport for the manufacturer to open and enter the European market.

In order for a product to enter the EU, it must be CE certified and the CE mark must be affixed to the product. Applicable products: All products in Europe.

BQB certification All Bluetooth products imported into the United States need to be BQB certified. If your product has Bluetooth function, whether you have a Bluetooth logo on the appearance of your product or not, you need to pass this certification, only recognize the main body, and do not distinguish between products, whether it is headphones, speakers or mobile phones and other products. Applicable Products:

Bluetooth-related products.

A 510(k) is a premarket submission to FDA that certifies that the device is at least safe and effective for sale on the market, that is, substantially equivalent to a legally marketed device (21 CFR a)(3)). Submitters must compare one or more similar legally marketed devices to make their devices and support them substantially equivalent.

FDA510(k) Exempt Registration for Medical Devices:

It consists of two parts: business registration and product listing. After the registration is completed, you can enter the corresponding registration code, query code, or enterprise name to check the relevant information on the FDA official website. The fee consists of two aspects.

One is the FDA annual fee charged by the United States, which is paid directly to the FDA treasury in the form of US dollars, and the annual fee for the next year is renewed from October 1 to December 31 each year to maintain the validity of the FDA registration, and the amount of the annual fee varies every year. The other is the ** fee charged (which includes company registration, product registration, and ** people in the United States).

Panama began using the Medical Supplies Act of 1966 in 1966 to regulate medical supplies, including chemicals, biological products, medical devices, herbal products, vitamins and minerals.

Peru's Medical Supplies Act 1989 is the main act currently regulating medical supplies and is designed to regulate the quality of medical supplies in Australia.

Arab Safety & Effectiveness offers a complete set of national programs. In 2002, Australia promulgated the Medical Device Regulations 2002, which is a special regulation for the management of medical devices.

The TGA implements the responsibilities of product market access and market supervision under the ** Supplies Act and the Medical Devices Regulations 2002, and ensures that medical devices listed in Australia meet the standards, and ensures the further development of Australia's first-class level and the medical device industry.

I also visually checked, it is true that Japan is different, Japan needs to go to the local registration to do it, domestic manufacturers need to go through JPAL certification, all other countries, belonging to the European Union need to apply for ISO13485 and CE certification, MDI class (non-sterilization, non-measurement) can be self-declared, no need to issue a certificate; Other non-EU countries need to apply for a free sales certificate (CFS) on the basis of CE certification, if you need to handle it, you can contact Shanghai Jiushun, certification and sales certificate we can handle. Thank you!

You can consult directly with the Food and Drug Administration, and every week the Food and Drug Administration has a free consultation window, which is available for free consultation, I remember it seems to be a week.

Two, four, you check again.

Except for Japan, which is more special, you can directly do CE registration to get basically all countries.

Of course, the process will vary depending on your product category.

Category I is sufficient as long as the self-declaration meets the requirements of the MDD Directive, while Category III is very cumbersome and requires all technical documents to be submitted to the competent authority of the country where it is located (usually Germany).

You can contact the relevant personnel of TUV SUD Shanghai.

I was doing medical device export this year and encountered the same problem. You've been doing it for so many years, what are the results, can you share it.

Export to Egypt Medical Device Registration Notes:

New, used, or refurbished medical devices must pass safety inspections in the country of origin, be approved by the U.S. Food and Drug Administration or the European Union Standards Agency, and be licensed by the Ministry of Health before they can be imported.

Importers are required to submit the following documents to the Ministry of Health:

Application for import of medical devices.

The safety certificate issued by the official health department of the country of origin of the medical device and the original certificate provided by the manufacturer, etc.

Importers must also demonstrate that they have a service center in Egypt that can provide after-sales services for imported medical devices.