HTW lab - Since 1980

10/11/2022

What is the Process for Obtaining a FCC Certificate?
Certificate
The FCC has three different processes under the EMC directive for administering certificate of compliances for electronic devices. The process for authorization is dependent upon device and type and power of rf emission. They will determine what method of screening your device will need to go through depending upon what type of device you’re trying to manufacture or distribute.

1. Verification (47 CFR Section 2.902)
Verification is the easiest method of authorization to pass in order to receive an FCC certificate. The verification process is used for digital products that are determined to have Part 15 components in order to obtain a part 15 certification. A device designated as Part 15 means the device either does not contain a radio or that it contains a radio that has already been approved. Part 15 devices only require verification; they do not need to receive approval and they do not need to bear a certified FCC logo.

2. Declaration of Conformity (DoC) (47 CFR Section 2.906)
A declaration of conformity (DoC) is the second easiest compliance process to go through in order to obtain an FCC certification. A DoC is used to test devices that contain or that are considered personal computers or peripherals of personal computers. Products that require DoC are considered Part 18 devices.

In order to receive Doc approval, FCC Part 18 devices must undergo testing in an accredited laboratory in order to measure the levels of radio frequency that are emitted from the product. Products that receive approval must show that they are in compliance with regulations by being stamped with the FCC logo.

3. Certification (47 CFR Section 2.907)
Certification is the hardest FCC approval process to achieve. The type of devices that require a certification have the potential to emit the highest amounts of radio frequency interference and cause the most harm to the public. A certification must be authorized and issued for radio frequency devices by an official Telecommunication Certification Body (TCB).

HTW will help you attain FCC Certification in less than half the time it takes the Federal Communications Commission (FCC). The Federal Communications Commission (FCC) is an independent government agency.

04/11/2022

What Does CE Certificate of Compliance Mean?
Certificate
A CE certificate of compliance allows a product to move and be sold freely throughout the European market. This mark provides proof for the consumer that the product meets the environmental, safety and health requirements set by the EEA. A guarantee of compliance is not a quality assurance. It simply means that the product meets the requirements to be sold in the EU.

It’s important to be aware of the fact that a CE stamp does not imply that a product was made in the EEA. A mark of European conformity means that it has been assessed and passed environmental, safety and health requirements that the EEA has set in order for a product to be sold in the EEA.

CE-marking is a mandatory conformity mark required for a wide variety of products. CE-marking indicates that your products comply with stringent EU product safety directives. Our CE-marking conformity assessment services provide you with the expertise you need to achieve compliance.

01/11/2022

How to Get CE Certification?

Determine which directive(s) are applicable to your product

Fulfill the essential requirements

Establish a monitoring system

Establish an accident reporting system

Declaration of Conformity

Save the documentation for 10 years after a product has been placed on the market

Register with the appropriate governing body within Europe

CE-marking is a mandatory conformity mark required for a wide variety of products. CE-marking indicates that your products comply with stringent EU product safety directives. Our CE-marking conformity assessment services provide you with the expertise you need to achieve compliance.

26/10/2022

Cytotoxicity Testing

The cytotoxicity test is designed to evaluate the general toxicity of medical devices and materials. Testing involves extracting devices in a cell culture media and then exposing the extract fluid to mouse fibroblast cells (L929). The cells are allowed to grow in the extract fluid for a specified amount of time before the cells are evaluated using either qualitative or quantitative methods. The test is performed on all medical devices with patient contact, raw materials, and devices undergoing a cleaning validation or residual manufacturing.

https://htwlab.com/Cytotoxicity-Testing.html

29/09/2022

What is Bioburden Testing?
Testing
For a sterilisation process to be effective on a newly manufactured pharmaceutical product or medical device, manufacturers must be aware of the number, properties and characteristics of microorganisms that occur in the products naturally or while going through the production process. This is a crucial step prior to setting sterilisation parameters such as dosing, temperature etc. to ensure that the process is effective and the product safe when used.

The purpose of bioburden testing is to enumerate the quantity of viable microorganisms on a pharmaceutical product, medical device, component, raw material, or package before sterilisation. Bioburden testing is also an important indicator of problems in the production process which could lead to product recalls later.

20/09/2022

How to Get FCC Certification?


Manufacturers who wish to sell telecom, licensed RF, and low-powered transmitters in the United States must have their products tested by FCC listed or accredited lab and certified by the FCC for EMC/Telecom compliance.

FCC Certification (FCC ID ) :

Specifically for wireless products, the certificate is issued by the TCB agency in the United States. When applying for certification, the company first needs to apply for a Code code. We issue a test report after the product has been tested, and the TCB agency reviews and issues the certificate.

FCC VOC (FCC verification):

This type of product is specially certified for ordinary electronic and electrical products, mainly testing radiation.

FCC DOC (Declaration of Conformity):

Mainly for IT products, computers and computer peripheral products.

HTW will help you attain FCC Certification in less than half the time it takes the Federal Communications Commission (FCC). The Federal Communications Commission (FCC) is an independent government agency.

14/09/2022

What is the SaSo certificate?
certificate
SASO is the abbreviation of Saudi Arabian Standards Organization (Saudi Arabian Standards Organization), and CoC is the abbreviation of Certificate of Conformity (Certificate of Conformity). Since August 2004, all products except for prohibited and exempted products are imported into Saudi Arabia. All need to obtain CC to clear customs smoothly. The goods that have not obtained the CoC will be detained during customs clearance, and the certificate can be issued after the spot inspection is qualified. The cost and time are much higher than that of obtaining the customs clearance certificate before shipment.

SASO is the abbreviation of Saudi Arabian Standards Organization (Saudi Arabian Standards Organization), and CoC is the abbreviation of Certificate of Conformity (Certificate of Conformity).

06/09/2022

What is FCC certification?
certification
It is the compulsory certification of the United States. Electronic and electrical products exported to the United States must pass the FCC certification before they can pass the U.S. customs and be sold in the United States!

Manufacturers who wish to sell telecom, licensed RF, and low powered transmitters in the United States must have their products tested by FCC listed or accredited lab and certified by the FCC for EMC/Telecom compliance. We provide independent FCC certification and testing services that will help get your products to market faster, enabling greater sales and revenue potential overall.

FCC certification and recognition: FCC certification is applicable to more than 50 states in the United States, Colombia and regions in the United States

https://www.htwlab.com/product-certification/fcc-certification-usa.html

HTW will help you attain FCC Certification in less than half the time it takes the Federal Communications Commission (FCC). The Federal Communications Commission (FCC) is an independent government agency.

30/08/2022

Each year, the Bluetooth SIG member community strives to deliver innovations that enhance the capabilities of Bluetooth technology and help shape new market trends. The upcoming adoption of LE audio will be the latest in a long line of Bluetooth enhancements that will have a significant impact on the wireless market.

According to SIG forecasts, annual Bluetooth device shipments will exceed 7 billion units for the first time in 2026. And peripheral devices will drive significant growth in single-mode Bluetooth LE devices. The Bluetooth market holds great promise!

CCIC-HTW provides "one-stop" service to help you solve the international Bluetooth market testing and certification problems, welcome to learn more.

https://www.htwlab.com/bluetooth-wifi-devices-testing.html

25/08/2022

Introduction to TGA Medical Device Registration in Australia

Australia has a strong health care system and a complete medical management and insurance system to provide people with complete health care services. At present, all medical supplies (drugs and medical devices) listed in Australia must be registered or registered with the Australian Register of Therapeutic Goods (ARTG) in accordance with the relevant requirements before they can be legally listed, to ensure the safety and effectiveness of medical devices are guaranteed.

Learn more-https://www.htwlab.com/TGA.html

16/08/2022

What is NMPA certification?

The NMPA is formed by integrating the responsibilities of the Food Safety Office, the responsibilities of the Food and Drug Administration, the production-level food safety supervision and management responsibilities of the General Administration of Quality Supervision, Inspection and Quarantine, and the circulation-level food safety supervision and management responsibilities of the State Administration for Industry and Commerce. It is responsible for drugs, medical devices, and cosmetics. And supervision and management of food safety in the consumer sector. CFDA was formally established on March 22, 2013, and Zhang Yong, director of the Office of the Food Safety Commission of the State Council, served as the first director and party secretary of the State Food and Drug Administration.

The CFDA certification has been changed to an NMPA certificate.

https://www.htwlab.com/China%20NMPA%20Certification.html

09/08/2022

What Is HSA？

With a well-established healthcare infrastructure and advanced healthcare system, Singapore is one of the most important markets for medical devices in Asia.

All companies must obtain a Dealer's License before manufacturing, importing, or supplying medical devices in Singapore to engage in related business activities.

Relevant companies can apply for a Dealer's License by submitting the documents required for each role online through HSA's Medical Device Information and Communication System, MEDICS.

Singapore's medical devices/IVD products are classified into four risk classes, A/B/C/D.

Learn more-https://www.htwlab.com/Singapore-HSA.html