Influence product certificate of medical device
1.What is product certificate of medical device?
Normally after registration process at different markets, legal manufacturers receive a certificate. Normally there is a unique certification number. The most certificates even validity as 5 or 10 years or even non-expired.
In figure below there are product certificate from Taiwan, EU and Canada.
The elementary contents on certificate are legal representative, legal manufacturer, applied law, classification, product name in subject language and country specific ID. The special elements on certificates are:
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China: info of distributor, expire date of certificate, annex PTR
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Japan: (D)MAH, annex as summary of dossier
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EU: number of notified body, basic UDI, Signature of PRRC
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510k at FDA: K-number, annex 510k summary
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Taiwan: Product name in traditional Chinese, production site
*Marketing authorised holder
2.What is free sales certificate?
A special form of evidence of home country approval is free sales certificate (FSC) in EU or export certificate as Certificate to Foreign Government (CFG) at FDA in US.
The reason of issuing this certificate extra might be that certificate could be easily falsified. The FSC or CFG has extra stamp. They are asked in many countries at application of medical device.
3.Which impact does product certificate have?
Besides acting as home country evidence to get approved in other markets, product certificate is controlled at customs, supply chains and at final users or institutions. 510k cleared or CE are most powerful marketing wording to show high level conformity with critical regulations of medical device.
For product registration, change of critical parts on product certificate triggers change registration.
Usually for sales, different certificates as many as possible is a plus point to win at tender.
4.Trace and decide critical contents on certificate
Due to common and special contents on product certificate, manufacturers should influence them during early stage of registration preparation.
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If any number of components on certificate makes trouble in post market, legal manufactures could summarise only the most critical components
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If legal representative or distributor is not a long years partner, legal manufacturer could chose neutral consulting partner.
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Almost all contents on certificates changeable are critical for triggering change registration or minor change notification. So keep contents simple.
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Because the description of features matter at tender, manufacturer could leave some unique specifications there against common products.
At the same time, the contents on certificate must be consistent with technical documentation submitted. A very usual mistake is to have other contents on labelling which makes in whole supply chains and in worst case at authority troubles.
Do you know that
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You should bundle similar products in one certificate
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You must separate products to increase sales impact and avoid risk of later splitting
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Certification number should be in combination with other country ID and issuance code
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Depending on change registration or renewal, certification number could be different
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