Classification and definition of medical devices

Medical devices refer to instruments, equipment, instruments, in vitro diagnostic reagents and calibrators, materials, and other similar or related items directly or indirectly used in the human body, including required computer software. It can be seen that the scope of medical devices is very broad. Its main purpose is to diagnose, prevent, monitor, treat or alleviate diseases, and so on.

China compliance

Classification and definition of medical devices

Wireless medical device export

Deeplight assists Korean customer to complete medical cosmetic equipment Safety/EMC/Environment/Performance/Cytotoxicity/Anaphylaxis/Skin Irritation etc China CFDA testing certification

As one of the most stringent areas in the supervision of various countries, medical cosmetic equipment are related to the safety of human. They will undergo a series of strict testing and certification before listing. China is also like that, medical cosmetic equipment need to be registered and certified, that is, CFDA certification for short.As a technical service company, Deeplight has sufficient resources to assist customers outside China to complete their CFDA testing and certification in China.

The products involve forehead thermometer, oximeters, pulse diagnosis devices, laser hair growth caps, heartbeat monitors, etc. We have accumulated rich experience in testing, knowing where failures often occur in various test items, we can provide professional services to customers.

Part.1

Under the close cooperation of a team of more than ten of our two parties, this medical cosmetic device project has fully communicated and coordinated. After a series of complex tests, the content involved is complicated, the test items are numerous, the test time is long, and the content includes:

(1) Testing and certification of product medical electrical equipment safety

GB 9706.1-2007 "Medical Electrical Equipment Part 1: General Requirements for Safety"

(2) Testing and certification of product electromagnetic compatibility

Test Standard YY 0505-2012 "Medical Electrical Equipment Part 1-2: General Requirements for Safety Parallel Standard: Electromagnetic Compatibility Requirements and Tests"

Carry out radiation field measurement test below 1GHz, electrostatic discharge immunity test, radio frequency electromagnetic field radiation immunity test, power frequency magnetic field immunity test.

(3) Testing and certification of product environmental suitability

The test standard GB/T 14710-2009 "Environmental Requirements and Test Methods for Medical Electrical Appliances", according to the characteristics of the product is divided into climatic environment, high and low temperature storage, transportation environment and other tests.

(4) Testing and certification of product performance

According to the product technical requirements written by the manufacturer, conduct operability, verification, and functional test tests, and judge whether the requirements are met.

(5) Testing and certification of laser product safety

Test standard GB 7247.1-2012 "Safety of Laser Products Part 1: Equipment Classification and Requirements"

(6) Preparation of pre-evaluation opinions on technical requirements for medical device products

According to national regulations, after pre-assessment, we can see if there are no supplementary or perfect opinions on product technical requirements, and whether the product technology requires further supplements and improvements.

(7) Biocompatibility testing and certification

A. Cytotoxicity test

GB/T 16886.5-2017

B. Allergy test

GB/T 16886.10-2017

C. Skin irritation test

GB/T 16886.10-2017

Part.2

Conclusion,after 2-3 months, debugging and retesting, and finally assisting the Korean customer to complete all necessary test items.

Welcome to consult our medical cosmetic equipment China CFDA testing and certification, we will assist customers with one-stop service from testing to auditing, and successfully obtain the Chinese market access.