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Related Laws and Regulations about IVD Approval in China

Tags: | NMPA | Medical Device | IVD | 药监局 | 医疗器械 | 诊断试剂 |

  

There are the following related Laws and regulations for IVD approval in China:

1. Provisions for the Registration of Medical Devices In Vitro Diagnostic Reagents (IVD)

2. Management Method of In Vitro Diagnostic Reagents Registration (Interim)

3. Principles and Procedures for the Coverage of Products Included in the Quality  Management System Examination for In-Vitro Diagnostic Reagent

4. Guidance for Manual of In-Vitro Diagnostic Reagent


Risky Food Export China Process
In China, the imported food is divided into 4 risk levels from low to high : A, B, C, D ; Different levels of supervision are adopted for foods with different risk levels;

The medium to high risky imported food categories include:Meat products, aquatic products, dairy products, sausage casings, bird nest products, bee products, egg products, edible oils and fats, oilseeds, stuffed wheaten products, edible grains, milled grain industry products and malt, fresh and dehydrated vegetables and dried beans, condiments, nuts and seeds, dried fruits, unroasted coffee beans and cocoa beans, foods for special dietary purposes, and health foods, Animal feed etc.

Dairy
Products

Meat
Products

Aquatic
Products

Animal
Feeds

GMO
Agriculturals

Dietary
Supplements

Infant
Formula

Fresh
Foods
More...

In addition to the above-mentioned general food import procedures, the risky imported food also need to go through other government procedures of Manufacturer Registration / Certifcation, Pre-market approval of the product etc.
 
The common China's government departments include :
Learn More China Pre-market Approval >>>
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