Importing medical devices from China requires full compliance with all applicable safety standards and regulations in the destination market. For many Startups looking to import medical devices, it can hard to even know where to look for information.
So, we decided to ask an expert.
In this Interview, Jason Lim, co-founder of Stendard, explains everything that you must know before importing and selling any product that may be classified as a medical device.
Jason, please introduce yourself and Stendard
I’m Jason Lim, CEO and co-founder of Stendard, a cloud-based platform that help companies generate documents to meet international regulations, such as ISO 13485 and US FDA 21 CFR of the medical device industry.
Having experience working with the local government, technology incubators and innovative companies here, I personally feel there are still a lot of improvements to be done when it comes to the entire compliance ecosystem (both from the industries’ and authorities’ standpoint).
That’s why I started the company together with Vincent Lim, COO of Stendard.
Our aim is to make compliance easily understood for businesses so to encourage standards adoption. This includes the usage of technology to accelerate the speed of document creation and management.
We are also planning to include partners to make the entire training, certification and registration process a breeze, and that’s what we meant by the term “compliance ecosystem”!
How do you (and regulators) generally define a Medical Device?
The medical device definition is quite well defined, but slightly varies between different countries. This means that a medical device may be classed as one in a particular country but not as one in the other.
One example of the medical device definition that is set by the Singapore’s Health Science Authority (HSA) can be found here.
It is also harmonised to the one proposed by the Global Harmonisation Task Force (GHTF), now represented by International Medical Device Regulator’s Forum (IMDRF). Their aim is to harmonise regulations across countries to promote trade.
What regulations do European importers need to be aware of?
The new European Regulations for Medical Device and In-vitro Diagnostics (IVD) have just been officially released earlier this year. It will take 3 and 5 years respectively for companies to move from the current directives to the new regulations.
The Notified Bodies (auditors) are also getting themselves prepared so they can begin auditing companies based on the new regulations.
As I know, most Notified Bodies still require another 12 months or so to be ready. Nevertheless, companies intending to market their medical devices in the European market should first go for ISO 13485 certification, except those that are exempted.
For product specific standards, companies can also identify the list of applicable standards here.
The objective is to review this list of standards and identify those that are relevant for your medical device, including symbols used in labels, electrical safety, EMC standards and etc. It is important to start this exercise early in your design and development phase.
With the company’s’ ISO 13485 processes in place, they should have 3 main product-specific files maintained – Medical Device File, Design and Development File and Production Records.
For CE Marking, the Technical File and the Safety and Performance Equipment Checklist is additionally required for auditor’s evaluation.
Companies can get the details of the technical file and checklists from the Annexes of the new Medical Device and IVD Regulation published.
For foreign companies that do not have a local presence, a European Authorised Representative (EAR) should also be appointed.
What regulations do American importers need to be aware of?
The US has one of the longest history in medical devices regulation. Their regulation is slightly different as well. For example, instead of recognising the ISO 13485 certification, they have their own regulation – US FDA 21 CFR.
The US FDA have their own enforcement officers that perform audits directly on companies, even when they are not based within US. Only recently, they are recognising the ISO 13485 framework but only to certain medical device types.
Generally, medical devices are categorised into Class I, II or III. I being the lowest and III the highest risk. Companies can first search and identify the product code and product classification that best fit their medical device through the US FDA database.
With this information, companies can identify the relevant standards that are applicable for their product classification here.
Most are internationally accepted standards, such as those from the ISO, IEC and etc. The most common pathway to a medical device approval in US is via the Class II 510(k) pathway.
The US FDA has recently updated this very useful guidance document to help companies identify the content required to file a 510(k) submission, including a detailed document checklist.
Say that I am based in Singapore. Is compliance with EU or US standards sufficient, or are there local regulations?
In this part of the world, Singapore is the first to put in place the Medical Device Regulation – a framework to control medical device sales within the country in 2010. Thus, local approval is required.
Pre-approvals in Europe or US can help to speed up the approvals by the Singapore authority though.
Although most of the countries have put in place their own regulation and framework, there is one thing that is really helpful – the recognition of the ISO 13485 certification as the de-facto international standard that medical device companies need to achieve. To explain further, ISO 13485 is a certification for medical device companies.
Being certified with ISO 13485 shows that a company has put in place a set of processes that meets the customers as well as regulatory requirements.
However, in recent years, we have also seen more companies adopting ISO 13485 as a differentiative factor to set themselves apart from their competitors and to attract international clients.
Do you generally need to get a pre-approval when importing Medical Devices?
Generally, yes! Pre-approval is required in most countries where they are regulated. However, there are some exceptions where some medical devices are of very low risk and do not require pre-approvals for sales.
Nevertheless, some form of licensing requirement is still required, although the medical device do not require the authority’s evaluation and approval.
Thank you Jason. How can Stendard help businesses looking to import Medical Devices and related products?
Stendard First™ helps companies generate customised documents to meet international regulations, such as ISO 13485 and US FDA 21 CFR requirements. Conventionally, most companies spend hundred over hours and tens of thousands of dollars on generating such documents.
With Stendard First™, the company goes through a series of Q&A and receive a set of customised documents within couple of hours. Click to watch introductory video.
This translates to more than 10 times cost and time saving spent on handling compliance documents.
Several consultancy firms have also leveraged on our technology to help them run their business more efficiently and productively. Give it a try today.