Port communicationDetailed introduction of Hong Kong Xintong Peng Yi Aaron said that when applying for medical device qualifications, we need to prepare the corresponding materials in the early stage.，According to the past handling experience of Hong Kong Xintong International, it can be simply divided into the following points:：(1) Cover page and catalog of Class III medical device wholesale application materials (including serial number，Material name，page number)；2、Medical device business license application form；3、business license、Copy of organization code certificate；4、Description of corporate organization and department settings；5、business methods and business scope。
(name according to the medical device classification catalog、code and management categories)；6、List of company personnel (name、gender、age、Educational qualifications、major、job title、Position、ID number)；。
7、Copy of ID card of the legal representative of the enterprise，ID card of the person in charge of the company，Copy of training certificate；Personnel's resume，letter of appointment，ID card，Education certificate，Professional title certificate，Copy of employment certificate and labor employment contract，Quality of certification materials for non-part-time employees 8；The person in charge of quality should also provide the qualification certificate of the medical device operating enterprise，Certificate of practice，Labor employment contract，Copy of proof of non-part-time job；The above-mentioned persons exceed the statutory retirement age，Copies of the retirement certificate and physical examination certificate issued by a medical institution above the second level in Shenzhen that are able to work normally should also be provided.；9、acceptance、repair、After-sales service、ID card of sales personnel、Academic certificate、Copy of job certificate and other related materials；10、Enterprises operating living medical devices and plastic corneal contact lenses should provide medical technician ID cards，Education certificate，Copy of employment contract and proof of non-part-time employment；Over the statutory retirement age，You should also provide a copy of the retirement certificate and physical examination certificate issued by a medical institution above the second level in Shenzhen and able to work normally.；11、Copy of lease agreement for business premises and warehouse，House ownership certificate；Floor plan of the business premises (indicate the actual area used) and geographical location map；Warehouse floor plan (indicate actual usage area and zoning) and geographical location map；12、office，List of facilities and equipment for storage and transportation；List of equipment for handling in vitro diagnostic reagents，Photos of the reservoir area，Cold storage inside and outside view，Refrigerated truck or car refrigerator，Transport vehicle photos，Photos of generators with generators etc.。
should also be provided；13、Medical device manufacturing enterprises applying for medical device business licenses，A copy of the medical device production license or registration certificate should be provided；office，Floor plan of the production site and its warehouse；14、Enterprises that entrust third-party logistics storage and transportation，A copy of the contract entrusting third-party logistics storage and transportation should be provided；15、Basic information and functional description of computer information management system；Enterprises that entrust third-party logistics storage and transportation，The description should include real-time docking with third-party logistics companies，Query，Supervision and other networks and databases；16、About enterprise quality management system，Documentation of working procedures, etc.。
17、Agent authorization letter and copy of ID card；。18、Other supporting materials that need to be provided further；19、Statement on the authenticity of administrative license application materials (administrative confirmation)。20、The relevant Food and Drug Administration has clarified the qualifications and conditions for operating some medical devices that require special management.
Require
of，Materials should be submitted in accordance with its regulations。
Based on the above twenty points, we can know that when applying for a medical device license，A very large amount of information needs to be prepared。When applying, you still need to go through multiple approval processes.，Therefore, when an enterprise needs documents related to medical device qualifications, it can consult Hong Kong Xintong International for processing.。
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。
