On the back of the World Economic Forum, Swiss Federal Councillor Alain Berset and Zhang Yong, the minister responsible for the China Food and Drug Administration (CFDA), signed a bilateral agreement relating to medical devices on 21 January 2015.
What is a Conformity Assessment?
When looking at this term in the specific category of medical devices and in the context of CE marking (for example), the term basically come out to the following:
“A medical device manufacturer’s claim that a product meets the essential requirements of all relevant European Medical Device Directives and meets legal requirements to place a device on the market in the European Union”. TforG discussed the topic of CE marking already in several earlier blog articles.
Depending on the type of device to be marketed, there are different procedures for manufacturers to demonstrate conformity assessment and some are easier than others.
Devices are divided into several categories depending on their complexity and risk factors, for example, class I devices are considered to be low risk equipment like crutches or wound dressings.
These type of devices are usually exempt from complex regulatory processes and conformity assessment consists basically on the manufacturer filling out a technical file declaring that the device in question meets directive requirements.
Class IIa, IIb and III devices must provide the above declaration with the additional back up of assessment testing and compliance with several contract annexes that are beyond the scope of this blog.
One can say that the system is quite complex and that in many cases partners with expertise in this area are extremely beneficial in helping to get products on the market.
We have explored conformity assessment in Europe and it is important to note that a series of variations on this type of quality control exists in different regions (e.g. Swissmedic for Switzerland, the China FDA for China, the FDA for the U.S., Medical Devices Bureau of Health for Canada etc.)
Partnership between China and Switzerland
With the high levels of complexity involved in conformity assessments and the lack of standardized requirements across countries doing business together, it is a smart move to form strategic alliances and partnerships that can help commercial deals run in a smoother and more efficient manner.
An excellent example of this type of partnership is illustrated in the recent alliance between China and Switzerland with the signing of their “Agreement on Cooperation in the Areas of Foodstuffs, Medicinal Products, Medical Devices and Cosmetics”.
China and Switzerland have always enjoyed close ties and evidenced by their history of shared views and collaboration.
- In 2005, a “Memorandum of Understanding” was established between the two countries.
- Both governments have expressed a commitment to promote, develop and facilitate access to high-quality medicinal products and medical devices to improve population health.
- Both countries have reaffirmed their belief in the importance of international standards.
- In 2013, a free trade agreement was signed between the two countries.
A recent article by Clinica Medtech Intelligence, talks about the latest in this series or partnership affirmations between China and Switzerland, namely, the signing of a bilateral agreement in the area of medical devices. The main goal of the agreement is to understand and harmonize the two country’s regulatory environment.
According to the same article, collaboration specifics will focus on:
- Building understanding and confidence in each other’s inspections reports and test data.
- Understanding each other’s post surveillance practices.
- The active exchange of information of medical devices.
- Sharing relative administrative level information on any violations that may occur in this field
Additionally a steering committee has been set up to supervise compliance with this agreement and serve as a liaison between Swissmedic and China’s FDA.
No doubt, that partnerships like this will become more ubiquitous in the future, aiding in the expansion and development of global partnerships.
For further quantitative information on the Chinese and Swiss healthcare system and the macroeconomic climate, please look into our Business intelligence platform or order the TforG Deep Dive report s containing the volumes of 620 surgical procedures in 13 specialisms.
About Ritza Suazo
Researches and creates Clinical Pathways and Country Deep Dive Reports at TforG. With almost a decade of experience in Clinical Market research she also manages and recruits the TforG advisory board. She graduated with a double major in psychology and international business management from Stony Brook University in New York and continues to apply her experience in research specializing in the US, UK, Spain and South American Markets.