How to search Chinese consultant (partner)?

Background and purpose of good Chinese consultant

It is always difficult to find a reliable and long term consultant or distributor or partner in China in life science sector. Even you have sound supplier qualification process compliant to ISO 13485, 7.4 Purchasing. If you audit your partner in China, there are another Chinese (culture, local policy, communication and language) impact factors.

Based on our experience we highlight some considerations for you to choose Chinese partner. It can be local representative for registration (Chinese agent), primary distributor, outsourced production, outsourced testing, joint venture and supplier of components.

The roles can be diverse and should be controlled with referenced Chinese and international regulation:

·        Communication with authority

·        Interface between overseas stakeholder and Chinese supply chain to end user

·        Accountability during the whole life cycle of products in China

·        Have quality management to monitor the quality of products

·        Protection of Intellectual property

Must have consultant character of Chinese partner

It raises always need to reconsider good consultants during the change of legislative, products and personal. The basic is contract which rules the principle and scope of the business. In the reality the hurdle are often accountable personal, misplanned projects and intransparent communications.

Contract with Chinese elements

We believe that every firm has its own template of contract with Chinese partner after typical NDA. However it is not specific enough to address the detailed service with extra cost, applicable chapter of law and controlling measure for quality.

The key for successful is not only time and cost but also reliable partnership. For the first a rough timeline and extra cost should be listed at beginning of project. It is always rational to put additional cost in a separate annex to avoid open astronomic sum of payment. The reliable partnership can be proved after project start and long term collaboration.

From legal enforcement perspective, we see more and more bilingual contracts. By distribute both parties know their responsibility.

Besides it, we list the basic factors to consider in a bilateral contract:

·        Start date of the project

·        Condition of termination and change of the partner

·        Proprietary right

·        Confidentiality of the data

·        Price of independent service

·        Responsibility and liability

·        Change assessment

·        Distributor management

·        Customer management (complaints)

Actually there are also offers or quotations for easy specular projects. Normally it is superficially formulated. Pay attention to feasibility of offer. It should content the tactic and details of projects. Sometime it makes sense to get a payed good offer.

Manpower is deciding

It is meant for both sites. It must not be fluent Chinese speaker. The manpower at Chinese project should be a person with patient, language, negotiation and flexibility skills. At brains it is better to have two gears to receive ,analysis, resolve and control the untypical questions.

Do you have years of Chinese partners without meeting them in a meeting or in the reality? This is No-GO. In Chinese culture we set value on personal relationship. A regular face to face meet up on - and off the project is recommended.

Project management with basic communication

We suggest to have a kick off meeting with new partner and challenge with some questions. So from beginning you know how Chinese partner handle the question W/O:

·        Hundreds emails

·        Proactive presentations

·        Personal meeting invitation

·        Direct telephone

·        Hundreds person in downstream involved

·        Thousands deciding canals

·        Immediate cost

·        Inefficient talking

What happens during and after project? Definitely you should have a controlling system. The tool can be milestone meeting with manager, meeting protocol to trace the question, communication matrix and KPI of projects.

Lessons learned are code of next successful, because the next project can be similar and the process might be the same.

Premium character of Chinese partner

You cant request your Chinese partners only from your views. Both parties should meet in the middle with each demand. Nevertheless if you wish a premium partner, we have some ideas.

Certification (global and Chinese)

Depending on which partner and in which international dimension, the recognised certification is reputable as ISO 9001, ISO 13485, ISO 15189 and ISO 17025.

At least you should ask a copy of business licence of your partners in China. The sales partner must have Good Sales Practise Certificate, manufacturing partner Good Distribution Practise Certificate and testing lab CNAS.

Otherwise you can inspect your Chinese partner. We are surprised that many small Chinese companies have professional quality management behaviour without paper certification.

High level communication

As said before at project management it is universal chaos, even with increasing interdisciplinary topics, multidepartment and changing manpower. The scenarios for high level communication can be:

·        A project leader with bilingual

·        A key participant with tactic decision

·        An uncomplicated decision policy in both parties

·        Fantastic understanding of 2 contact person

·        Impartial moderator

·        Weekly (monthly) meeting

·        Trouble tracing tool 

·        Pragmatic management of budget and time

In case of Chinese agent and Chinese distributor

1.Regulatory monitoring

The strengthened legislative in medical device and IVD in China forces Chinese agent and distributor not only follow corresponding regulations but also transfer the change of regulation earlier in English to overseas partners.

2.Product information (e.g. Labelling and UDI)

The products after approval in supply chain should be consistent with the model submitted to authority. If product change happens, Chinese agent should support to analysis whether it impacts safety and effective or raise new risk of products.

It is always mysterious which marketing material is at user. So better all involved parties have a backup of final Chinese instruction for use, label, UDI, issuance code, certification number, Chinese product name.

3.Reclamation, serious adverse event and recall

The accountability of post market after product approval needs co-working of both parties (legal representative and distributor) if they are not the same.

The easiest way is to rule these activities at each contract or post market amendment in a process who, till when and what to proactively to do. The outcomes are traceable post market records.

4.Training

Do you train your Chinese distributor in personal course; either in China or in headquarters? We are surprised that many Chinese distributors try to understand the products and troubleshoot on their own. Even the Chinese advertisement and material is limited correct without aligning with legal manufacturer.

5.Inspection

How does your Chinese distributor handle with storage, transport, good receipt, installation, maintenance, non-conformity, vigilance items and labelling of products? As legal manufacturer, you have to inspect your critical Chinese partners.

6.Liability

Regarding liability it means registration as service for Chinese agent and products for Chinese distributor. EU SME might have not own subsidiary and have these 2 roles outsourced. You should ask yourself by drafting the contract: Are the terms of service or products clearly formulated? Who bears liability for regulatory obligatory (post market report) and adverse events?

7.Data protection and privacy

It cant control your partner in term of data protection and privacy with typical national laws. However, the basic requirements should be described to make them aware of data protection of all product- and project  specific data beyond the third party.

8.No-GO with Chinese partners (Best ECA practise)

So we try to be polite to formulate indirectly what is No-Gos in the medtech sector.

·        No original certificate (without translation of key info)

·        No copy of submitted registration dossier

·        Intransparent communication in case of customer-related issuers as complaints

·        More than 50% payment at earlier stage of project

·        No detailed additional services with hourly or flat fee

·        No active regulatory update

·        No specialist with basic English

·        No project management (too much reacting by doing)

·        No notification by sub-contractor

What can we support?

Contact us anyway for the typical regulatory consultant. Otherwise we as neutral party could support to:

·        Chose a Chinese partner

·        Audit your Chinese partner with defined quality management

·        Provide a checklist in customer need for Chinese partner

·        Distributor controlling with regulatory view