Authorised legal representative for foreign manufacturer of medical device and IVD
What is Authorised legal representative?
Authorised legal representative of medical device is a legal person in most markets who in behalf of legal manufacturer to register medical device to authority. Depending on country Authorised legal representative has different names, roles of submitting or keeping technical documentation, at liability product distribution and at Market Surveillance.
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We just list some typical authorised legal representatives below.
(Designated) Marketing Authorization Holder, Japan
Brazilian Registration Holder
Product licence holder, Taiwan
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Role of authorised representative
The main role of authorised representative is to submit technical documentation to local authority (besides EU legal representative). This might be only way for foreign manufacturer who has no legal representative with fulfilled conditions. Usually legal representative speak local language and acts as liaison between foreign manufacturers.
Here two examples:
Chinese agent:
Article 20
At Regulations on the Supervision and Administration of Medical Device (State council order 2021/739) it stipulates:
Registrants and record holders of medical device shall perform the following duties:
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Establish and adapt product quality management system and applies it effectively;
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Development of post-marketing studies and risk management plan and to ensure the effective implementation;
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Carry out adverse event monitoring and re-evaluation in accordance with the law;
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Establish and implement product traceability and recall system;
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Other obligations stipulated by the drug regulatory department of the State Council. The domestic legal person designated by overseas manufacturers shall assist the registrant and filing party in fulfilling the obligations stipulated in the preceding paragraph.
domestic legal person = Chinese agent
US agents role:
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assisting FDA in communications with the foreign establishment,
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responding to questions concerning the foreign establishment's devices that are imported or offered for import into the United States,
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assisting FDA in scheduling inspections of the foreign establishment and
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if FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.
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The role of authorised representative should be studied, ruled at contract and maintained. At the end, foreign manufacturers want to get product approved through legal representative. So in every market, the main role of legal representative is to register product at authority. Legal representative can be translated to In-country regulatory representativefor product registration.
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Behind the scene of authorised representative, no regulation is written about regulatory monitoring. In this case especially for non-English spoken market, local representative should at least assist to monitor new regulations.
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Besides Marketing Authorization Holder in Japan, no authorised representative in global market has full power of attorney of medical device or IVD. Legal manufacturer has liability for the whole lifecycle of product.
Scenario of authorised representative
Prior to analyzing the scenario of authorised representative, we want to emphasize that no legal representative has primary goal for distribution. For foreign manufacturer, it is very often that the role for legal representative (regulatory) and distributor (sales) is separated. This constellation between legal manufacturer, distributor and legal regulatory representative MUST be considered in contract.
Scenarios of authorised representative as:
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1. Own subsidiary
It is only advantageous
2. Neutral consulting
Most typical for foreign manufacturers without entity at markets.
+ The consulting has experienced regulatory knowledge.
+ The consulting has no interest to involve sales.
- It might need authorization of legal representative for tender.
- It might be difficult to change the consulting if it is written n product certificate.
3. Distributor
+ It is not rare to assign this role to a partners since years
-It is impossible or difficult to change distributor
4. First consulting, then Distributor
+ it is in trend that critical technical document of product is on site of neutral consulting.
+ It is beneficial to outsource consulting for product registration
- Conflict may happen between consulting and distributor.
How to search authorised representative?
So authorised representative are actually door openers to a new market and regulatory guarantors regarding the product registration.
By searching a professional authorised representative for new market entry, the followings should be critical:
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Contract of authorised representative with regulatory elements
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Local obligation of authorised representative (Good supply practise, liability, market surveillance)
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Conflict analysis in term of supply chain
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Labelling on product
It is complex to choose and update best authorised representative. It could be not easy for a start-up or start-up or small and medium enterprises (SME) without huge experience of global registration of medical device.
Our affiliate writes an article about “How to search Chinese consultant (partner)?”. With us you can either have the whole registration project or outsource only regulatory tasks cooperating with your Chinese partners
What can we also support?
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Be your regulatory partner in multi-markets
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Search and analyse legal representatives
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Audit your legal representatives as critical supplier with defined quality management
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Provide a checklist in customer need for legal representatives with assessment
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