Medical Device Certification Service

Your Industry Medical Treatment Medical Device Certification Service

Medical Device Certification Service

We provide technical certification services for medical device products at home and abroad

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Service Introduction

As an important equipment to protect people's life and health, governments of all countries have set up strict control mechanisms for medical devices which are divided into Class I, II and III in China. For Class II and III products, the registration and inspection are required, and Class I products should be reported for inspection. The GRG Test can provide domestic NMPA registration certification and export testing certification services for different medical device products.

Certification Cycle:

Depend on the service, usually about 4 weeks

Medical Device Certification Service

1. China NMPA medical device registration certification

Medical devices are divided into Class I, II and III in China. For Class II and III products, the registration and inspection are required, and Class I products need to be reported for inspection. Registration and inspection includes security testing, EMC testing, biological testing, clinical trials, etc. and it usually takes several months. For unqualified test items halfway, then rectification and retest shall be conducted, which will make it even more difficult to grasp the overall progress. The medical device technical team of GRG Test started to provide one-stop professional services such as product pre-test, rectification design service and registration agency in 2014 and can always help customers to quickly obtain registration certificates.

2. Medical device export testing and certification

(1) CE Certification

· Medical device directive (MDD 93/42 EEC);

MDD is applicable to most medical equipment entering the EU for sale. It is divided into 6 grades according to different requirements and evaluated by certification bodies.

The testing standards involved in MDD include:

IEC/EN 60601-1 series

IEC/EN 60601-2-X series

In Vitro Diagnostic Directive (IVDD) 98/79 EC Certification

With the adoption of the European In Vitro Diagnostic Medical Devices Directive (IVDD 98/79/EC), the requirements of the Directive are enforced in all EU member States.

(2) US FDA Certification

The export testing and certification of medical devices generally takes a long cycle and high risks. Having cooperated with many foreign certifying authorities since 2010, GRG Test has built up years of experience in system counseling, risk assessment, testing services, rectification design, etc.

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