主頁 | 項目與研討會 | How to successfully export medical materials under the pandemic
 
How to successfully export medical materials under the pandemic
 

 The new COVID-19 pandemic affected all over the world. There were over Two million cases diagnosed in the world. All countries are facing shortage of medical supplies. As the main manufacturing location in the world, China has also actively undertaken the important role of manufacturing of PPE medical caused for the world. Since March 2020, China has exported over 3.86 billion pieces of surgical masks, 37.52 million pieces of protective clothing, and 16,000 breathing machines.

Due to the huge amount, there were challenges from stakeholders among these medical supplies, For example: The quality control of the product, different quality standards of China and foreign countries, and differences in usage habits and which would affect overall product quality. Facing with the current situation, relevant China government department had emphasize the need to strengthen the supervision of these exported medical materials. It has focus on five types of products, which needed to fulfil the requirements strictly:

l Testing reagents

l Medical masks

l Medical protective clothing

l Ventilators

l Infrared thermometers

The exporters needed to obtain the registration certificate of medical device produced in China and meet the quality standards of the importing country (region). The medical & PPE products are now mainly exporting to the EU market. These countries have their own import requirements for different medical & PPE products.

It would include CE certification, Medical Device Directive 93/42 / EEC (MDD), Medical Device Regulations EU2017 / 745 (MDR), ISO 13485 Medical Device Quality Management System, Personal Protection Equipment Regulations EU2016 / 425 (PPE), etc.

l What products need to meet what standards?

l How to fulfil the standard requirements?

l Which certification is required for which particular product?

l What is the process to undertake these certificates?

 

On 20th May 2020, Bureau Veritas senior experts in the medical field will give you detailed answers to the knowledge of testing, inspection and certification of the entire supply chain: From procurement, manufacturing, trade to retail so to help the organization to export the medical supplies products (such as surgical masks) to the world successfully.

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   適合人士 :
 

l Medical Device industry (Masks and PPE……etc)

l Medical Device Importers / Exporters

l Manufacturers

l Consultants

l Any other parties interested in Medical Devices Testing / Certification

 
   大綱 :
 

Date:           20 May 2020

Time:          2:30 pm – 5:00 pm

Venue:       Online webinar

Language: Cantonese

Fees:           Free of Charge

Speaker:    Mr. Bryan Lok, Senior Manager, Global Technical Services – Softlines, Bureau Veritas Customer Products Services

Speaker:    Mr. Marvin Ng, Medical Device Product Manager, Senior Auditor; Area manager of Bureau Veritas Certification HK

 
   工作坊詳情 :
 

l Face masks testing standards introduction

l Introduction of Medical Device Requirements in Europe and North America.

l The latest European MDR regulations

l Introduction of ISO 13485:2016 standard

l Q & A

 
   申請表格 :
 
 
*必須填寫          
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聯絡人        
電話        
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代表名稱 1 電話 電郵 職位
       
代表名稱 2 電話 電郵 職位
       
代表名稱 3 電話 電郵 職位
 
 

lParticipation code are limited and on first come first served bases; Max. 5 participates per company.
lParticipation methods are notified by email confirmation
lBureau Veritas Certification Hong Kong Limited reserves the right for final seats reservation decision.
 
Any enquiry, Please don’t hesitate to liaise Ms. Mia Wong, Tel.: 2157 8550 and Email: mia.wong@hk.bureauveritas.com

 
 
 
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