Navigating database of medical device global
Preface of global database of medical device
For diverse stakeholders of medical device there is a hiding database in global market to explore valuable information of medical device. The name of database and how to search in each market is different. One common purpose is to search approved medical device in subject market.
The following can be interested for sales person, product manager, business manager, regulatory affairs manager, quality manager:
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Approved manufacturer on the same group
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New (cancelled) medical device
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Competitor with same product code
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Applied standards and guidance
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Data of vigilance
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Instruction for use, UDI
Before searching it could be nice to have at least info among certification number (oft on packaging and instruction use), manufacturer name, product name, product code or name of local representative.
From EU to MDSAP and China etc.
Eudamed in EU
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You can find useful info as medical device under MDR, authorised representative, importer, manufacturer, system pack producer, competent authority, Summary of safety and clinical performance (SSCP), basic UDI-DI, certification type, starting and expiration date of certificate.
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UK Public Access Registration Database (PARD)
It is under Medicines and Healthcare products Regulatory Agency (MHRA).
Manufacturer will find UK responsible person, GMDN code MHRA reference number and approved medical device.
Swiss Database on Medical Devices
Planned releases see figure, it will be similar to PARD.
There are different ways to search listed manufacturer, approved medical device under 510k or PMA, medical device reports, post-approval studies.
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Unfortunately in Japan you can just search approved manufacturer and medical device in annual publication.
The authority Anvisa has also a smart tool to search approved medical device, many info in Portuguese as licence holder, product name and even user manual can be downloaded.
In Australia these filter can be used for search: sponsor name, manufacturer name, GMDN, product name, and intended purpose.
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In health Canada you can find valuable info through company name, licence name, device name, licence number and device identifier.
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Actually the database here is useful more for Chinese speaker to search approved medical device in all classes, Chinese standards and Chinese GMP.
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On the Chinese certificate, you could find Chinese agent, model, composition, intended use etc.
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In this database you have to try luck with English term. If you were lucky, you could hit approved medical device with all models, QSD number and classification.
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For professional regulatory - or product- or business development manager
In China and US there is a huge mentality of “equivalent” at product registration. So it is wise to search approved competitor and to use the data in comparison table. E.g. 510k summary is a good summary to study how competitor register similar product.
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For product manager in medtech field is good to know in time in which market competitor has marked which new product with innovative products. These on regional database are good resource as business analysis.
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Even by searching local representative and local distributor, many databases could show the records of approved medical device under searched name. It could leverage to select local partner too.
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For M&A Due Diligence, it is absolute nesseesory to scan one companies international business
It is tough to align with fast pacing global regulation. We dedicate to include all information in our eLearning with interaction with participants with personal coach.
Chose the international session what you want to learn, we will make a personalized eLearning right away for you.
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