Port communicationDetailed process for registering a medical device company in Shenzhen，Abbreviated as "Hu" or "Shen"，A municipality directly under the Central Government of the People's Republic of China，national central city，megacity，China's economy、transportation、science and technology、industry、finance、trading、Exhibition and shipping center，The first batch of coastal open cities。
The medical device industry involves medicine、mechanical、electronic、Plastics and other industries，It is a multidisciplinary、knowledge intensive、Capital-intensive high-tech industries，It is an industry that is developing very rapidly in modern society.，There are currently many industries where investors。How to register a medical device company in Shenzhen?
medical device company
Registration process
：
Application conditions
：Warehouse area is greater than 15㎡，The office area is greater than 30㎡ and in accordance with the Food and Drug Administration’s
Require
Layout Step 1 Industrial and Commercial Name Check Required Materials： 1.Application form for pre-approval of name 2. Proof of investor’s identity 3. Registered capital、Investment ratio Processing time：Complete materials，When the names are not repeated，3Working days The second step is to apply for a medical device business license (1) "Notice of Acceptance" Required materials： (1) "Medical Device Business Enterprise License Application Material Registration Form"； (2) "Shenzhen Medical Device Business Enterprise License Application Form"； (3) Certificate of pre-approval of enterprise name issued by the industrial and commercial administration department or a copy of the "Business License"； (4) ID card of the person in charge of quality management of the proposed enterprise、Copies of academic qualifications or professional title certificates and resume； (5) ID card of the quality management personnel of the proposed enterprise、Copy of academic qualification or professional title certificate； (6) The organizational structure and functions of the proposed enterprise or the functions of full-time quality management personnel； (7) Registered address of the proposed enterprise、Geographical location map of warehouse address、Floor plan (specify area)、Copy of property ownership certificate or lease agreement (with property ownership certificate for leased housing attached)； (8) Proposed enterprise product quality management system documents (11 documents) and storage facilities、Device catalog； (9) Business scope of the proposed enterprise，According to the management categories specified in the medical device classification catalog、Class code name determined； (10) Business license and product registration certificate of the entrusted seller of the product to be sold (copy)、power of attorney； (10) Electronic declaration materials；(required for Pudong drug test)； (11) Other supporting documents required。
attached：Specific application materials
Require
： (1) The content of the table cannot be missing items，The handwriting must be clear (2) Submit at the same time the electronic version of the application form (placed on a floppy disk) and the written information in A4 size (fax paper cannot be submitted as information) (3) The application materials submitted by the applicant should be complete、specification、Valid (2) "Medical Device Business Enterprise License" (1) After approval and acceptance，25On-site inspection by the drug inspection department within 10 working days。
(2) The "Medical Device Business Enterprise License" will be issued within 10 working days from the date of decision to grant the license.。
Processing time：After all materials are received,，25working days. The third step of industrial and commercial registration requires materials.： 1、Proof of the designated representative or jointly appointed agent of all shareholders (power of attorney) and a copy of the work permit or ID card of the authorized person； 2、Notice of pre-approval of company name； 3、Legal person qualification certificate or natural person identity certificate of the shareholder； 4、Application form for registration of corporate legal person signed by the chairman or executive director of the company； 5、Shareholders' meeting resolution (stamped by shareholders)、Signature of natural person shareholder)； 6、Board resolution (signed by all directors)； 7、Articles of Association (stamped by all shareholders)，Group limited companies also need to submit group articles of association (stamped by group member companies)； 8、Name company directors、supervisor、Manager's name、Documentation of residence and related delegation、Proof of election or employment，These include： (1) Letter of appointment (solely state-owned)； (2) Letter of appointment (stamped by the appointing unit)； (3) Chairman or executive director of the company、director、supervisor、Manager's employment certificate； (4) Company directors、supervisor、Copy of manager’s ID card； 9、Capital verification report issued by a legally qualified capital verification agency；(After the implementation of the new company law on March 1, 2014，This document is no longer required for subscription enterprises) 10、Proof of company residence，To rent a house, a rental agreement must be submitted (with a copy of the property ownership certificate)； 11、Within the company's business scope，Belongs to the law、Administrative regulations stipulate that projects must be submitted for review and approval，Submit approval documents from relevant departments； 12、law、Administrative regulations stipulate that the establishment of a limited liability company must be submitted for approval，Submit approval documents from relevant departments； 13、A complete set of registration forms and other materials issued by this Bureau。
Processing time：After the materials are complete，5working days
About Hong Kong Xintong
Hong Kong Xintong focuses onGuangdong and Hong Kong license plates、Shenzhen Hazardous Chemicals Business License、Shenzhen labor dispatch licenseandShenzhen Charity Foundationapplication services，Assist customers to applyShenzhen travel agency business license、Shenzhen pawn shop business license、Shenzhen auction house license and other mainstream domestic financial licenses，Support enterprises to achieve compliance expansion of cross-border financial business。Also availableODI overseas investment registration、International travel agency registration and other services，Help enterprises expand their presence in international markets。Provide one-stop compliance solutions for enterprises。To learn more，Please contactHong Kong Information Communications Consultant。
