Dr. Astro BEST AVAILABLESolutions  
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Why Choose Dr. Astro BEST AVAILABLESolutions  
China & US 24/7 team  
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Sourcing the  
BEST QUALITY  
PPE  
10+ Manufacturer Partners that pass  
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our rigorous Dr. Astro 5-step  
selection criteria  
ENSURE  
Full Compliance  
w/ US FDA  
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LOCAL  
Customer  
Service &  
Product  
Expert team in areas of  
Chinese company DD  
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Medical device quality  
US FDA regulatory compliance  
Import/Export  
Support  
BEST  
In the USA  
Shipping  
Solutions  
International shipping solutions  
SMOOTH  
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Import/Export  
Regulatory  
Customs  
We resolve all the challenges so our  
clients can focus on SAVING LIFES  
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1. Sourcing the BEST QUALITY Respirator, Glove, Isolation Gown  
Dr. Astro 5-Step Due Diligence (DD) Process  
Step 1: Company Information DD (China & US)  
Company history  
Legal records  
Shareholder and equity structure  
Records at NMPA (Chinese FDA)  
Credit history  
Records at US FDA  
Step 2: In depth DD on the Company  
Industry Reputation  
Local Reputation  
Product quality history  
Step 3: On-site Inspection (China)  
Our team will visit the manufacturer and inspect the facilities, manufacturing and quality control processes on-site, and talk with the company  
management. We will learn about the company short-term and long-term plan, understand the culture of the company, and make sure the company has  
a long term vision for the business.  
Step 4: Product documentation (China + US)  
We will check all the product documentations including test reports, registration documentations, instructions and labels, packaging, etc, and translate  
all Chinese materials into English,  
Step 5: Product Inspection (Performed in the US). Samples will be sent to our US team for further inspections.  
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2. ENSURE Full Compliance with US FDA  
Our US team, led by BioSculptor President Mark Mazloff, ensure that the products are in full compliance with current FDA requirements.  
Example A: FDA registration of N95 Respirators under EUA  
NMPA approved GB 19083-2010 (Chinese N95): equivalent to the FDA 21 CFR 878.4040(b) (i-iii.) standard N95 respirators  
GB 2626-2006 (KN95): equivalent to the NIOSH N95 standard  
Example B: Surgical gowns  
Sold as Class I medical device in the US  
• NMPA approved YY/T 0506 “Standard Performance” surgical gown: equivalent to the AAMI PB70 Level 2  
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3. BEST Shipping Solutions  
Shipping Method Speed  
Price  
Dr. Astro’s Uniqueness  
We use Fast Boat Direct service that are 40% faster than the  
normal freight ship, while keeping the cost low and maintaining  
a reliable delivery schedule.  
Global Economy  
3 weeks Low  
Products are delivered in batches continuously using a  
combination of air and fast boat. Clients will start receiving  
quickly, while optimally designed combination will keep the  
shipping cost low.  
ASTRO Plan  
1-3  
weeks  
Medium  
We will select the optimal flight route so as to minimize delays  
in transitour plan is typically 30 faster than FEDEX.  
Global Express  
1 week  
High  
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4. SMOOTH Import/Export/Customs/Regulatory Process  
Life without certainty:  
New Government Regulations enacted every weeksometime even changed during the same day  
U.S.A.  
Government Dept.  
US DEPARTMENT OF  
HEALTH AND HUMAN  
SERVICES  
Date  
Effect  
Regulation  
Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against  
COVID-19.  
2020/1/31 public health emergency  
US CDC  
WHO  
2020/2/29 Includes KN95 from China.  
2020/3/11 Pandemic  
Strategies for Optimizing the Supply of N95 Respirators  
COVID-19 declared as Pandemic  
US White House  
US FDA  
US FDA  
2020/3/13 US COVID-19 National Emergency Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak  
2020/3/25 EUA application guidline V1  
2020/3/28 Did not include China  
Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency  
Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators  
US FDA  
US FDA  
2020/4/3 Specifically designed for China.  
2020/4/3 EUA application guidline V2  
Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China  
Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency  
China  
Government Dept.  
Date  
2020/3/15 A large number of products are  
- exported, and the customs does not  
2020/4/10 strictly examine the qualification  
Ensure product quality and safety,  
Effect  
Regulation  
Non-medical only need product certificate. Medical proudcts need CFDA registration certificate and medical device  
production license.  
Customs of PRC  
For five categories of products: the the novel coronavirus reagents, medical masks, medical protective clothing, respirators  
and infrared thermometers, the company MUST provide written statements to customs promising that the export products  
Ministry of Commerce of  
PRC  
Customs head office  
CFDA  
standardize export order, and  
2020/3/31  
prevent export of medical products have obtained the registration certificate of medical devices in China, and in conformity with the quality standards of the  
by non-medical manufacturers.  
To strengthen the supervision of  
2020/4/10 the export quality of medical  
materials  
importing countries (regions).  
Export commodity inspection shall be carried out for medical products under the HS# of "63079000000"  
Customs head office  
Medical use and non-medical use cannot be wrongly claimed or else goods confisticated with severe punishment. Strict  
requirement for packaging specifications and qualification certificates, the inner packing and outer packaging shall be  
regulations for protective products printed with the quality standards of the exporting country and no sticker or sharpies can be used on the label. A lot list of  
Ministry of Commerce of  
PRC  
Customs head office  
CFDA  
2020/4/10  
Special commodity inspection  
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2020/4/16  
certificate and reports required.  
Administration of market  
supervision, PRC  
Customs head office  
Export of small express parcels have been requested for strictly inspection. Mainly checking whether the labels and  
packages are in compliance with the regulations and whether they are fake. In case of any doubt, the items will be  
withheld. Purchase invoice need to be shown to prove the authenticity of the products.  
2020/4/16 Strictly check the export  
-now qualification of medical supplies  
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4. SMOOTH Import/Export/Customs/Regulatory Process  
Our experienced team will manage the ever-changing environment to ensure a smooth process.  
When there are situations, we will work 24/7 so you don’t have to lose your sleep:  
Our normal hours of work: 7 days/week  
In urgent situations (ie. new regulations released), our team will work around the clock  
We deliver certainty in the uncertain environment:  
1 project manager with direct contact information designated for your order  
Daily update on order statusif delays are expected, we will switch to twice or more updates daily  
24/7 emergency line response  
best response time to changes in government regulations  
We are the best team in navigating through the regulations, and the first to get the PPE (Personal Protective Equipment) to you.  
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5. Local Customer Service & Product Support in the USA  
BioSculptor will provide post-marketing support locally in the US.  
BioSculptor is a Class II medical device manufacturer in Hialeah, FL, with FDA FEI #1000560772. The company was incorporated in  
1972, with medical products sold in the US, EU, and China.  
Client log-in website for detailed product information  
Customer Service & Product Support  
Phone: 305-823-8300  
The designated manager’s mobile phone # will be provided upon PO.  
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