Wearable Medical Device Registration in China

Wearable medical devices are the medical devices combined with technic like sensors, wireless communication, multi-media and etc. There are two main features for the wearable medical devices. One is wearable and intelligence. The other is medical device with functions such as monitoring, adjuvant therapy and etc. (Ex: wearable thermometer, wearable glucometer.) And in European and US, the price of wearable medical devices varies from tens to hundreds of US dollars. Also most of the wearable medical devices are accepted by the customers.

I. The general type and development of wearable medical devices

General type: Monitoring, physical therapy and treatment.
Recently, the maximum amount of wearable medical devices are monitoring type, however, the amount of physical therapy and treatment type are increasing steadily. And most of the registered wearable medical device are electrocardiograph monitoring products.

Ex: The local wearable medical device already registered in China that you can compare with your products.

Product Type	Name of the Products	Product Management Type	Intended Use
General Diagnosis instrument	Wireless temperature monitoring system	6820	Apply to continuously human body temperature measurement.
Clinical Analytical Instruments	Wearable blood glucose monitor	6840	Apply to Glucose concentration monitoring in human capillaries
Medical Electronic Equipment	Wearable heart monitor	6821	Remote ecg monitoring and analysis for cardiac patients
Medical electronic equipment	Wearable electrocardioelectric electrode system	6821	Working with ecg monitoring equipment. Apply to Cardiac monitoring under non-strenuous exercise
Medical high-frequency equipment	Medium and low cycle therapy machine	6826	Working through electrical stimulation to reduce muscle cramps and improves blood circulation. It is used for relieving shoulder soreness and peripheral nerve palsy

Imported wearable medical device already registered in CFDA that you can compare with your products.

Export country	Name of the Products	Registration type	Wearable method	Intended use
Belgium	Cefaly	FDA registration	Head ring, wearing on head	Headache Prevention and treatment

II) Characters of wearable medical devices registration

Wearable medical devices always have batteries or power supply, so it belongs to active products. And the electromagnetic compatibility and electrical safety testing are required for the wearable medical devices CFDA registration.
Wearable medical devices will touch the skin, so the biocompatibility tests are needed for the materials in contact with the skin.
In general, wearable medical device have software. Companies should be care about the software safety level, software describing documents and software performance tests.
Some of the wearable medical devices are adding the sensor and multimedia. Thus, the clinical tests are necessary.
Industry standards for reference

Related standards	Standard Chinese name
GB/T 191-2008	《包装储运图示标志》(EN: ‘Packaging and Shipping Label’)
GB 4793.1-2007	《医用测量、控制和实验室用电气设备的安全要求第1部分：通用要求》 (EN: ‘Medical Measurement, Control and Laboratory Electrical Equipment Safety Requirement’, part one: general requirement)
GB/T 18268.1-2010	《测量、控制和实验室用的电设备电磁兼容性要求第1部分：通用要求》(EN: ‘Medical Measurement, Control and Laboratory Electrical Equipment electromagnetic compatibility Requirement’, part one: general requirement)
GB/T 14710-2009	《医用电器环境要求及试验方法》(EN: ‘Medical electric appliance environmental requirement and test method’ )
GB/T 16886	医疗器械生物学评价(EN: ‘Medical device biological evaluation’)
YY 0505-2012	《医用电气设备第1-2部分：安全通用要求-并列标准：电磁兼容要求和试验》(EN: Medical electric appliance part 1-2: general safety requirement -- collateral standard: electromagnetic compatibility Requirement and tests’ )
GB 9706.1-2007	医用电气设备第1部分：安全通用要求(EN: Medical Electrical Equipment part one’)

III) Notification procedures and requirements for the wearable medical devices.

Stage	Registration procedures	Imported products	Domestic products	Attention
1	Market listing in the original manufacturing country	√	×	The products registration models and specifications should be the same as the original market listing country.
2	Find a legal representative	√	×	The legal representative should be Chinese local organizations or business entity and approved by the Chinese government.
3	Confirm products management type	√	√	Confirm product type
4	Products registration test	√	√	1.Prepare the products technical requirements according to the products’ characteristic
				2., Prepare the instructions and labels based on requirements of CFDA 6^th Statute
				3. CFDA approved registration test institutions.
5	Commission test	√	√	1. It mainly includes biological evaluation.
				2. Finish the test and biocompatibility evaluation in the GLP labs and follow the ISO standard.
				3. If not satisfy to point 2, companies could do the test and biocompatibility evaluation in Chinese GLP labs that approved by the CFDA.
6	Clinical evaluation	√	√	1. If the products are not in the clinical test exemption category and already finished the clinical test in China, companies could compare the similar products and prepare the clinical evaluation documents based on the ‘medical device clinical evaluation guideline’.
				2. If the products are not in the clinical test exemption category and cannot get the clinical test documents from the similar products, companies should do the clinical test in China and submit the clinical evaluation documents based on the ‘medical device clinical evaluation guideline’.
				3. Clinical evaluation should be included in the original products’ clinical test documents.
				4. Do clinical test in the CFDA approved clinical test institutions.
				5. Physical therapy products generally end in clinical treatment.
7	Registration declaration and obtain certificate	√	√	Imported medical devices: Consistent notarization: registration related documents, original text and certificates. Notarial notarization: Companies signature and stamp
				2. Registration information should be authentic.
				3.Research documents should be detailed that include ISO13485 design, development and verification documents
				4. Products declare documents should be subject to CFDA 43th statute issued in 2014.
				5.Quality system verification: Domestic medical devices: Quality system verification during registration declare. Imported medical devices: Quality system verification if necessary.
Comments： After the registration of domestic medical devices, companies should apply for the medical device production certification before distribution.

* If you have any questions about wearable medical devices, feel free to contact CIRS at md@cirs-group.com.

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