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Foreign netizens comment on Chinese protective clothing

Shanghai Sunland Industrial Co., Ltd is the top manufacturer of Personal Protect Equipment in China, with 20 years’experience. We are the Chinese government appointed manufacturer for government power,personal protection equipment , medical instruments,construction industry, etc. All the products get the CE, ANSI and related Industry Certificates. All our safety helmets use the top-quality raw material without any recycling material.

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Foreign netizens comment on Chinese protective clothing
In Vitro Diagnostics | India
In Vitro Diagnostics | India

As a manufacturer of an in ,vitro diagnostic, (IVD) medical device, you must ensure you meet the relevant requirements outlined in the In ,Vitro Diagnostic, Regulation (IVDR) (EU) 2017/746.. An IVD Medical Device is defined in the IVDR as “any medical device which is a reagent, reagent product, calibrator, control material, ,kit,, instrument, apparatus, piece of equipment, software or system ...

In-Vitro Diagnostic Kit
In-Vitro Diagnostic Kit

India regulate Import, Manufacture, Sale, Distribution and Clinical Performance of In-,Vitro Diagnostic, Medical Devices under Medical Device Rules 2017, w.e.f 1 st January, 2018.. ,Diagnostic kits, manufactured in India require to obtain the license from State Licensing Authority (SAL) / Central Licensing Authority (CLA), depending upon their classification.

In Vitro Diagnostic (IVD) Products
In Vitro Diagnostic (IVD) Products

Assays and ,kits, that enable clinical laboratories to create and deploy next-generation sequencing-based molecular ,diagnostic, tests. ... New ACOG ,Guidelines, Recommend NIPT for All. ... ,For In Vitro Diagnostic, Use. Contact an Illumina representative for regional availability.

Guidance on the IVD directive
Guidance on the IVD directive

2.1 What is an in ,vitro diagnostic, medical device? The Directive (see also Regulation 2) defines an IVD as: ‘any medical device which is a reagent, reagent product, calibrator, control material, ,kit,, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by

Overview | Public Health
Overview | Public Health

Directive 98/79/EC of the European Parliament and of the Council on in ,vitro Diagnostic, Medical Devices (IVDMD) On 5 April 2017, 2 new Regulations on medical devices and in ,vitro diagnostic, medical devices establishing a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety were adopted.

In vitro diagnostic medical devices: guidance on ...
In vitro diagnostic medical devices: guidance on ...

Guidance explaining the main features of the In ,Vitro Diagnostic, Medical Devices Directive 98/79/EC. Published 19 August 2013 Last updated 26 February 2019 — see all updates

In vitro diagnostic medical devices: guidance on ...
In vitro diagnostic medical devices: guidance on ...

Guidance explaining the main features of the In ,Vitro Diagnostic, Medical Devices Directive 98/79/EC. Published 19 August 2013 Last updated 26 February 2019 — see all updates

US manufacturing guideline for IVD products.
US manufacturing guideline for IVD products.

1. Med Device Technol. 2000 Oct;11(8):23-4. US manufacturing ,guideline, for IVD products. Donawa M(1). Author information: (1)Donawa and Associates Ltd, Rome, Italy. donawa@srd.it Non-US manufacturers marketing in ,vitro diagnostic, (IVD) products in the United States (US) or planning to do so should be aware of a US Food and Drug Administration (FDA) manufacturing ,guideline,.

Guidance on the IVD directive
Guidance on the IVD directive

2.1 What is an in ,vitro diagnostic, medical device? The Directive (see also Regulation 2) defines an IVD as: ‘any medical device which is a reagent, reagent product, calibrator, control material, ,kit,, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by

Diabetes - In-Vitro diagnostic kits | Cisbio
Diabetes - In-Vitro diagnostic kits | Cisbio

IVD/CE certified ,kits, for Diabetes and related autoimmune diseases. Historical panel of assays with high robustness and precision. Diabetes - In-,Vitro diagnostic kits, | Cisbio

Diagnostic Kits/USA Regulation Review - Commons Based Research
Diagnostic Kits/USA Regulation Review - Commons Based Research

30/6/2010, · 2.1 In-,Vitro Diagnostics, (IVD) ,Kits,; 2.2 Laboratory Developed Tests (LDTs) 2.3 In-,Vitro Diagnostic, Multivariate Index Assay (IVDMIAs) 3 FDA Regulations. 3.1 Classification System of "Medical Devices" 3.2 510(k) Pre-Market Notification (PMN) 3.3 Pre-Market Approvals (PMAs) 3.4 FDA Regulations That Cover IVDs, LDTs, and ASRs. 3.4.1 The "ASR Rule ...

Regulatory Approval and Classification of In Vitro ...
Regulatory Approval and Classification of In Vitro ...

The Regulatory Approval and Classification of In ,Vitro Diagnostics, Rules 2017, was updated by Ministry of Health and Family Welfare, which will come into force on January 1, 2018.This will replace the country’s Drugs and Cosmetics Act for creating effective regulation.. As per the ,guidelines,, In ,Vitro Diagnostics, rules are used for diagnosis in which it is classified based on their level of ...

Veterinary Biologics Guideline 3.19: Guideline for ...
Veterinary Biologics Guideline 3.19: Guideline for ...

In addition to the present ,guideline,, manufacturers that intend to submit an application for regulatory approval of an in ,vitro diagnostic, test ,kit, as a veterinary biologic should review Veterinary Biologics ,Guideline, 3.1E: Guidance for Preparation of New Product Licensing (Registration) Submissions for Veterinary Biologics, for additional information regarding licensing applications and a ...

ISO - ISO 23640:2011 - In vitro diagnostic medical devices ...
ISO - ISO 23640:2011 - In vitro diagnostic medical devices ...

ISO 23640:2011 is applicable to the stability evaluation of in ,vitro diagnostic, medical devices, including reagents, calibrators, control materials, diluents, buffers and reagent ,kits,, hereinafter called IVD reagents.

The Technical Guidelines for In Vitro Diagnostic Reagents ...
The Technical Guidelines for In Vitro Diagnostic Reagents ...

The technical ,guidelines, provide general requirement of in ,vitro diagnostic, reagents only. Due to in ,vitro diagnostic, reagents have the features of developing rapidly, the wide distance between fields of specialization, different intended use, so the clinical trial measure and content are different for the products with different intended use.

The Technical Guidelines for In Vitro Diagnostic Reagents ...
The Technical Guidelines for In Vitro Diagnostic Reagents ...

The technical ,guidelines, provide general requirement of in ,vitro diagnostic, reagents only. Due to in ,vitro diagnostic, reagents have the features of developing rapidly, the wide distance between fields of specialization, different intended use, so the clinical trial measure and content are different for the products with different intended use.

In Vitro Diagnostic (IVD) Products
In Vitro Diagnostic (IVD) Products

Assays and ,kits, that enable clinical laboratories to create and deploy next-generation sequencing-based molecular ,diagnostic, tests. ... New ACOG ,Guidelines, Recommend NIPT for All. ... ,For In Vitro Diagnostic, Use. Contact an Illumina representative for regional availability.