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Items: 1 to 20 of 101

1.

[Reference and Innovation: Research on the Construction of Medical Device Registrar System].

Xu L, Lin S, Hu L, Yang Y, Wu Z, Huang J, Jiang H.

Zhongguo Yi Liao Qi Xie Za Zhi. 2019 May 30;43(3):192-196. doi: 10.3969/j.issn.1671-7104.2019.03.010. Chinese.

PMID:
31184077
2.

[Study on the Disclosure System of the Evaluation and Approval Information of Medical Device Review in Japan].

Chen M, Deng G, Liu J.

Zhongguo Yi Liao Qi Xie Za Zhi. 2018 Sep 30;42(5):357-360. doi: 10.3969/j.issn.1671-7104.2018.05.013. Chinese.

PMID:
30358351
3.

[Study on the reform and improvement of the medical device registration system in China].

Wang L.

Zhongguo Yi Liao Qi Xie Za Zhi. 2012 Nov;36(6):426-32. Chinese.

PMID:
23461120
4.

[Administrative reform thinking on the regulations on the supervision and administration of medical devices].

Yue W.

Zhongguo Yi Liao Qi Xie Za Zhi. 2014 Sep;38(5):357-60. Chinese.

PMID:
25597085
5.

Medical device regulation for manufacturers.

McAllister P, Jeswiet J.

Proc Inst Mech Eng H. 2003;217(6):459-67.

PMID:
14702983
6.

[Study on Regulations of Exemption in Medical Device Registration and Approval Process in the United States and China].

Hu K, Yang H.

Zhongguo Yi Liao Qi Xie Za Zhi. 2019 Mar 30;43(2):122-125. doi: 10.3969/j.issn.1671-7104.2019.02.013. Chinese.

PMID:
30977611
8.

Review and approval of medical devices in China: Changes and reform.

Liu W, Shi X, Lu Z, Wang L, Zhang K, Zhang X.

J Biomed Mater Res B Appl Biomater. 2018 Aug;106(6):2093-2100. doi: 10.1002/jbm.b.34031. Epub 2017 Oct 28.

PMID:
29080388
9.

Recent policies that support clinical application of induced pluripotent stem cell-based regenerative therapies.

Azuma K, Yamanaka S.

Regen Ther. 2016 Mar 1;4:36-47. doi: 10.1016/j.reth.2016.01.009. eCollection 2016 Jun. Review.

10.

[Simple Suggestion of Adapting Requirements of Medical Devices New Supervision Regulation System for Medical Device Manufacturers].

Li Y, Chu Z, Fan Y.

Zhongguo Yi Liao Qi Xie Za Zhi. 2017 May 30;41(3):220-223. doi: 10.3969/j.issn.1671-7104.2017.03.017. Chinese.

PMID:
29862773
11.

[Options for a future-oriented innovation policy in the medical devices industry].

Nusser M, Lindner R.

Z Evid Fortbild Qual Gesundhwes. 2010;104(10):709-14. doi: 10.1016/j.zefq.2010.08.004. Epub 2010 Oct 12. German.

PMID:
21147432
12.

[Exploring Flow and Supervision of Medical Instruments by Standing on Frontier of the Reform of Free Trade Zone].

Shen J, Han M, Lu F.

Zhongguo Yi Liao Qi Xie Za Zhi. 2017 Nov 30;41(6):436-439. doi: 10.3969/j.issn.1671-7104.2017.06.012. Chinese.

PMID:
29862705
13.

The current situation and development of medical device testing institutes in China.

Yang X, Mu R, Fan Y, Wang C, Li D.

Expert Rev Med Devices. 2017 Apr;14(4):263-269. doi: 10.1080/17434440.2017.1299572. Epub 2017 Apr 19. Review.

PMID:
28388243
15.

[Medical Device Regulation as current challenge for the legally safe introduction of new technologies].

Klar E.

Chirurg. 2018 Oct;89(10):755-759. doi: 10.1007/s00104-018-0705-3. Review. German.

PMID:
30187174
16.

Orthopaedic surgeons and the medical device industry: the threat to scientific integrity and the public trust.

Gelberman RH, Samson D, Mirza SK, Callaghan JJ, Pellegrini VD Jr.

J Bone Joint Surg Am. 2010 Mar;92(3):765-77. doi: 10.2106/JBJS.I.01164. No abstract available.

PMID:
20194337
17.

[Comments and suggestions on the medical device standardization system from the view point of medical devices test].

Yang X, Wang C, Yang Z, Li D.

Sheng Wu Yi Xue Gong Cheng Xue Za Zhi. 2013 Jun;30(3):546-51. Chinese.

PMID:
23865316
19.

The new collaborative path in medical device development: the medical device innovation consortium.

Kampfrath T, Cotten SW.

Clin Biochem. 2013 Oct;46(15):1320-2. doi: 10.1016/j.clinbiochem.2013.03.021. Epub 2013 Apr 8.

PMID:
23578741
20.

A Comparative Study of Medical Device Regulations:: US, Europe, Canada, and Taiwan.

Chen YJ, Chiou CM, Huang YW, Tu PW, Lee YC, Chien CH.

Ther Innov Regul Sci. 2018 Jan;52(1):62-69. doi: 10.1177/2168479017716712. Epub 2017 Jul 7. Review.

PMID:
29714608

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