Outsourced testing

Outsourced testing, valid for Chinese NMPA, MDR in EU and global markets

Tags: outsourced testing, verification and validation, clinical trial with multicentres, medical device, CNAS, ISO 17025, ASCA-Accredited, tetsing in China, 器械检验，欧洲临床检验，CE证书

Background of Chinese testing

Do you have headache of Chinese testing of medical device or IVD or medical components or wireless? It goes always unplanned difficult due to unprofessional support, communication, monitoring. It wastes money and time which is sometime even higher and longer than at registration.

Well known is type testing in China which is an important part at Chinese registration. You have to send your product to a certified testing labs or institutes. Actually you need in some cases more labs to cover different microbiological, chemical, environmental testings.

Unknown is that there are more and more certified Chinese labs and institutes (CNAS, ISO 17025, ISO 9001 and ISO 13485). You can have a quick schedule with applied international standards. With the English report you can serve in different markets (US, EU, Asia, Latin America). So don’t limit your satisfaction for a testing of finished medical device. As medical components, wireless parts and packagings, you can always find cost-saving, qualitative Chinese labs during the development or in pre-market stage, better not briefly prior tosubmission.

Benefit of outsourced testing in China

It is worthy to outsource the Chinese testing. You don’t need strain own R&D department or project management. We have a tool of proved certified Chinese testing labs and institutes. Even not, we can have a research with your need to find wished labs and inspect any new partners upon your QM-requirements.

Here are some benefits to outsource Chinese testings:

· Unburden own R&D

· Compliant to either Chinese or international standards or both

· A tool of certified Chinese labs and institutes

· Project management with testing knowledge

· Optimised SOP of Chinese testing

· Bilingual communication in and outside China

· Accompany the local testing and troubleshooting

· Overseas training to know your product

· Fast and cost-saving project

· Support of any follow up actions with distributor or Chinese agent or authority

· Leverage global registrations by checking final report

Service and more

We list the basic standards upon which the test will be executed. Ask us to which international standards you want to test, we will match the testing labs and institutes.

IEC 80601 series
IEC 61010 series
IEC 61326 series
GB/T 14170
IEC 62133, UN38.3
ROHS, Reach
GB/T 25000.51
ISO 11135, ISO 11137, ISO 17665
GB 16886 series (corresponding ISO 10993 series)
GB 9706 series (valid since May, 2023) corresponding IEC 60691 series
SRRC, NCC, FCC, MIC testing
Accelerated & Real-Time Aging

Your outsourced verification test without applied standards

· outsource any Chinese projects as Chinese clinical study

· have tests in any of our international partner labs

· have gap analysis of testing in China of new medical device

Chinese standards mentioned in essential requirements

Workflow of outsourced testing of medical device

Below is a basic workflow. In our offer we will concretise the responsibility, time, cost and milestone meeting of testing.

Testing in Europe and worldwide

医疗器械的出海检验

The testing inEurope in many certified labs (certified to ISO 17025 or Certification Body Testing Laboratory or Accreditation Scheme for Conformity Assessment at FDA) can be used for Chinese and global registration. It makes sense to have a testing project beyond the registration preparation because it can be executed parallel and normally takes longer than expected.

We can support you to do testing in Europe too because we have many partner labs who have sound reports accepted by different authority.

Recently the quality and truthfulness of Chinese lab is decreasing expecially at FDA. After warning it makes sence for Chinese manufacturer to assign testing of medical device in Europe.

We can

· accompany from test plan to final test report review

· edition of test summary addressing country regulatory requirements

· answering deficiency reply (or additional request) by different internal agencies and notified body

· have life cycle control when to repeat testing or revise the testing summary

General testing

Chemical composition
Surface analysis (XPS, SEM, EDX)
Validation of process (sterilization, disinfection, clean room, freeze drying, chemical synthesis and decontamination)

Biological evaluations

· Biocompatibility (ISO 10993 – and ISO 18562 series)

· Toxicology

· Mutagenicity

· Genotoxicity

Some special testings

AAMI ST98

Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices.

V V 40 – 2018

Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices

Customized laboratory testing

Depending on device or IVD or component you need special testing aligning on no standard. We can develop testing method to identify the questions

Clinical study according to ISO 14155:2020

it can be multi-centre international clinical study of medical device. The advantage of clinical trial in Europe is real data from european patients.