Mandatory or Recommended? Demystifying China’s Medical Device Standards

I remember the old days when companies felt like they had conquered the world by holding the approvals for EU EC certificate and FDA clearance.

The company asked the question like, “Why do we still need to file an additional notification or submission in other countries when we got a marketing approval from the country of origin?“ Regulatory/Quality specialists will immediately sit straight up and look confused at the person who asked this question.

Well, this is a valid question for those who do not have a regulatory/compliance background! Developed countries or territories, such as EU, US, South Korea, etc. have invested tremendous efforts to improve and maintain a robust regulatory framework to ensure only safe and effective products are placed in the market.

However, the notion that if someone has an existing approval should not dismiss the credibility and robustness of health regulators from other countries. We have to keep in mind that the potential differences in electrical configuration, anthropological, and other aspects may affect the safety and effectiveness of the product.

Local standards and requirements guide manufacturers in designing a device that is safe for the use of the intended population group of a target country. So, it is crucial to identify what local standards apply to your product.

How many types of China’s standards exist?

There are 5 types of standards in China. This includes National, Industry, Regional, Association, and Enterprise standards. Wait, did I just mention 5 types? Yes! 

The format of China’s standard is similar to ISO standard. It comprises either 2- or 3-alphabet code depending on the standard type, followed by a sequence of numbers and the year of standard approval. GB 9706.1-2020 as an example.

However, only 2 types of standards are applicable for medical devices - National and Industry standards. These two types are further branched into 3 categories, respectively. The types can be shown using a 2×3 matrix as below. Don’t worry, it is simpler than the risk management matrix. 

GB and YY are marked as “Mandatory”, meaning you must comply with the compulsory standards unless you have a robust rationale. GB or YY 9706 series for basic safety and performance is an example.

The letter “T” depicts behind GB and YY signifies “Recommended“, meaning this depends on the characteristics of your products.

GB/Z exists only for national standards. They are guiding standards on top of the existing standards.

This can be weird for those who are familiar with the harmonized standards. There is only one type of ISO standard, although multiple modified versions exist under different jurisdictions.

BUT, there is a distinct difference between harmonized and Chinese standards. The amendment or date of new versions does not stack up like the ISO standards. It replaces the previous version.

Where can you find local medical device standards?

Now it is the exciting part that you’re waiting for.

There are currently 2023 active standards by the end of 2024 according to the official NMPA report. There are 296 national and 1727 industry-specific standards. Among them, 265 are mandatory and 1752 are recommended standards. Compared to 2023, this signifies an increase of 24 national and industry standards in China, respectively. This statistic excludes the amended standards.

Where can you find all the standards? There is a public database with a list of all medical device standards. Sadly, it is only available in Chinese.

1. Go to https://www.nifdc.org.cn/nifdc/index.html
2. Scroll down to locate “Data Inquiry/ 数据查询”
3. Click on the “Medical Device Standard/ 医疗器械标准”

Nevertheless, it is a useful source to cross-check which standards are still valid and whether it refers to any ISO standards. You can use Google Translate plugin to translate the page.

Be sure to click on the “Check/ 查看“ to reveal further details, such as the standard name in English, the list of previous versions, reference to an ISO standard (if applicable), and standard published and effective dates.

There is another nice feature about this database. You can read some standards online for free. I was able to access and download a few standards last year. But the download function was brought down due to copyright concerns.

How can I show compliance with those standards?

Let’s face the truth. Manufacturers usually struggle with local standards when China was not on the radar during their product development and planning. The local standards and requirements were not known, so no assessment has been done. Suddenly, the market demand appears, and you want to enter China’s market. Not another additional market on the table …

According to the “Medical Device Standard Management Order” (Order no. 33 of 2017), it is stated that “Product Technical Requirements (PTR) of the medical devices should align with the features of the product design, intended use, and level of the quality control. The requirements of your product should not be lower than what has been stipulated in the applicable National and Industry Standards.”

So, testing according to a well-formulated PTR is the key to demonstrating compliance with local standards that apply to your product. PTR is one of the most critical documents the registrant needs to prepare as part of the submission.

The market demand might not be obvious at the beginning. Understandable, but reverse engineering does not sound fun either. If you have a strict timeline and your product fails to meet the standards, it is a PANIC MODE!

If you are reading until the end of this post, you are an avid learner like me! Feel free to subscribe to my newsletter and share it if you find this article useful (or not!). I get excited when I see a notification from you on LinkedIn. It fuels me and will keep me pumped to write more good content for you!

Just shoot an email to [email protected] if you have any questions or suggestions on what I should write next!

PS: PTR and local testing relevant topics will be covered in the upcoming weeks.

Disclaimer: This content is created solely in my personal interest and do not reflect the views, opinions, or policies of my employer or any other organizations I am affiliated with. The information provided is for informational purposes and should not be construed as professional advice. Neither I nor my employer is liable for any use of this content. This newsletter is non-commercial and does not compete with my employer’s interests. Any references to regulatory updates or guidance are based on publicly available information and are not intended to infringe upon proprietary or confidential content.