Application for extension of the validity period of a medical device permit license shall be made within six months of the expiration. Those who fail to apply for an extension before the deadline must re-apply for registration and market approval, and may not submit extension applications. However, in the case of Class II and Class III medical device, the re-applying registration may be applied with following documents within six months after the expiration of the original permit license:
1.One copy of each the original and photocopy of the medical device registration and market approval application form.
2.Photocopy of the pharmaceutical firm permit license as a domestic medical device manufacturer, or an imported medical device dealer.
3.Photocopy of the originally-approved medical device permit license.
4.Photocopy of the already approved instruction leaflet and labels stamped with tally impression of the central health competent authority.
5.Two copies of each of the following items: the form for attaching outer box instruction label with all Chinese instruction leaflet catalog packaging, and labeling, instructions for use, and color pictures of the physical appearance of product.
6.The original copy of the manufacture and free sale certificate of the country of origin.
7.Original copy of foreign original manufacturer continual authorization letter.
8.Documents verifying that the manufacturing factory in conformity with the GMP for Medical Devices.
The medical device applying for foregoing paragraph registration is commissioned to manufacture or analysis, it shall be in conformity with the Regulations for Medicament Contract Manufacture and Analysis.
In the event of domestic Class II or Class III medical device applying for registration according to the proviso of Paragraph 1, is exempted from submitting documents specified in Subparagraph 6 and 7 of Paragraph 1.

The following documents shall be attached when applying for extension of the validity period of a medical device permit license:
1.A medical device permit license validity period extension application form approved by the special municipality, county and city health competent authority of the pharmaceutical company's locality.
2.Original copy of the medical device permit license.
3.The original copy of the manufacture and free sale certificate of the country of origin.
4.Original copy of foreign original manufacturer continual authorization letter.
5.Certificate of in conformity with the GMP for Medical Devices. Product items in accordance with the Article 4 Appendix II of the Regulations for Governing the Management of Medical Device are exempted from this subparagraph.
The medical device applying for foregoing paragraph application is commissioned to manufacture or analysis, it shall be in conformity with the Regulations for Medicament Contract Manufacture and Analysis.
In the event of applying for extension of the validity period of a medical device permit license for a domestically manufactured medical device, the applicant is exempted from submitting documents specified in Subparagraph 3 and 4 of Paragraph 1.
In the event of applying extension of the validity period of a medical device permit license of a Class I medical device, in addition to complying this article, Articles 14 and 16 shall be applied mutatis mutandis.
If meeting one of the following circumstances, documents of the Subparagraphs 5 in the Paragraph 1 may be substituted with photocopies of documents verifying compliance with GMP for Pharmaceuticals:
1.The medical device applying for registration was regulated as a pharmaceutical product before. This rule applies within three years from the date of proclamations of listing change.
2.The medical device was regulated as a pharmaceutical product before January 1, 2013. This rule applies within three years from the promulgation date of the September 5, 2014 amendment to this Regulation. The manufacturing factory with valid medical device license shall not be approved for extension if it fails to conform to the GMP for medical device.
For the application for extension of a permit license in accordance with Paragraph 1, the central health competent authority may order submission of relevant documents if there are doubts about the safety and efficacy of the product concerned.