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Necessity Certification (Beijing) Co., LTD.

Necessity Certification (Beijing) Co., LTD.

Necessity Certification (Beijing) Co., Ltd. is a third-party certification body with independent legal person status approved by the National Certification and Accreditation Administration Commission (approval number: CNCA-R-2021-892), and has implemented industrial and commercial registration. It is a legal entity with dual national accreditation qualifications for product certification and quality management system certification.

Won the trust of medical device supervision and management departments, various medical device manufacturers and the majority of medical device users

Won the trust of medical device supervision and management departments, various medical device manufacturers and the majority of medical device users

Nasaiwei conscientiously implements relevant national laws and regulations, operates in a standardized manner and certifies according to the requirements of the national certification body accreditation criteria. Nasevi has inherited all the qualifications of the original China Medical Device Quality Certification Center, and has an experienced team of nationally registered auditors, auditors and experts, and has accumulated rich certifications in product certification and quality management system certification for many years. Experience.

Keep pace with the world's medical device certification level

Keep pace with the world's medical device certification level

Nasaiwei conscientiously implements relevant national laws and regulations, operates in a standardized manner and certifies according to the requirements of the national certification body accreditation criteria. Nasevi has inherited all the qualifications of the original China Medical Device Quality Certification Center, and has an experienced team of nationally registered auditors, auditors and experts, and has accumulated rich certifications in product certification and quality management system certification for many years. Experience.

Draft for comments on "Key Points of Technical Review for the Registration of Class II Medical Device Dressing Products in Hunan Province"

Draft for comments on "Key Points of Technical Review for the Registration of Class II Medical Device Dressing Products in Hunan Province"

In order to guide the registrants in our province to develop, verify and register the second-class medical device dressing products, unify the review scale, and improve the quality and efficiency of the registration review, our center organized and drafted the "Hunan Province Second-class Medical Device Dressing Products". Key Points of Registration Technology Review (Draft for Comment)", which is now open for comments.

Hubei Province Medical Device Quality Announcement (Issue 1, 2022)

Hubei Province Medical Device Quality Announcement (Issue 1, 2022)

Hubei Province Medical Device Quality Announcement (Issue 1, 2022)

Anhui Province Medical Device Quality Announcement (No. 3, 2022)

Anhui Province Medical Device Quality Announcement (No. 3, 2022)

Anhui Province Medical Device Quality Announcement (No. 3, 2022)

"Guidelines for Stability Studies of Passive Implantable Medical Devices (Revised 2022)"

"Guidelines for Stability Studies of Passive Implantable Medical Devices (Revised 2022)"

"Guidelines for Stability Studies of Passive Implantable Medical Devices (Revised 2022)"

"Guidelines for Intravascular Guide Wire Registration Review"

"Guidelines for Intravascular Guide Wire Registration Review"

"Guidelines for Intravascular Guide Wire Registration Review"

"Administrative Measures for Inspectors of Shanxi Provincial Drug Administration"

"Administrative Measures for Inspectors of Shanxi Provincial Drug Administration"

"Administrative Measures for Inspectors of Shanxi Provincial Drug Administration"

Won the trust of medical device supervision and management departments, various medical device manufacturers and the majority of medical device users

Won the trust of medical device supervision and management departments, various medical device manufacturers and the majority of medical device users

Nasaiwei conscientiously implements relevant national laws and regulations, operates in a standardized manner and certifies according to the requirements of the national certification body accreditation criteria. Nasevi has inherited all the qualifications of the original China Medical Device Quality Certification Center, and has an experienced team of nationally registered auditors, auditors and experts, and has accumulated rich certifications in product certification and quality management system certification for many years. Experience.

Necessity Certification (Beijing) Co., LTD.

NCE continues to track the development of international medical device certification, keeping pace with the world level of medical device certification, and has a wide range of exchanges and cooperation with medical device certification institutions around the world.

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