Determine the Regulatory Obligations via Searching Medical Device Catalog

As part of medical device management policies, China Food and Drug Administration (CFDA) has compiled serial catalog corresponding to the legislation of medical device. Those lists are used primarily to determine the regulatory obligations in China.

The following table summarizes the main medical device catalogues in China. if you would like to get the English version of the below catalog, please fill in the Order Form (word) or (pdf) and send it to Ms. Windy | windy@cirs-group.com or MD@cirs-group.com.

No.	Catalog	Unit	Amount	Latest update
1	Catalog of Medical Devices Classification	Category	3181	July 2015
2	List of Medical Device Code	Code	43	Feb. 2014
3	Catalog of Medical Devices Exempted from Clinical Trials	Device	567	Aug. 2014
4	List of Medical Devices for Priority Management	Category	9	Sep. 2014
5	List of Medical Devices Restricted to OEM	Category	4	Sep.2014
6	List of Medical Device Testing Institute Approved by CFDA	Institute	31	July 2015
7	List of Clinical Trial Institute for Medical Devices	Institute	312	July 2015
8	Catalog of Medical Devices Standard	Standard	1381	July 2015
9	List of high risk medical devices	Device	73	Apr.2010
10	List of Medical Devices need to be approved prior to Clinical Trial	Device	15	Sep.2013

• Catalog of Medical Devices Classification

The Catalog of Medical Devices Classification contains over 3000 kinds of medical devices approved in China. It enables you to determine the managing category/class of medical device with regulatory controls by classification code, classification name or product name, and to further determine the regulatory obligations under CFDA regulations.

• List of Medical Device Code

The List of Medical Device Code is compiled according the China medical device regulations to distinguish the different category of medical device. It is best to code the medical device during the supervision and management. This list enables you to know how medical product code distributed in China. Such as the IVD product belongs to code 6840.

• Catalog of Medical Devices Exempted from Clinical Trials

The Catalog of Medical Devices Exempted from Clinical Trials in China is released by CFDA according to “The Regulations for the Supervision and Administration of Medical Devices” and “Administrative Measures for Medical Device Registration”, If you product is listed in this catalog, it would be exempted to conduct clinical trials in China, but the clinical evaluation report would be must.

• List of Medical Devices for Priority Management

The List of Medical Devices for Priority Management is implemented to manage the high risk medical devices during the manufacture and distribution. Any manufacturer produce medical product listed on this list, they will be required to be evaluated by provincial authorities at least once per year via all technical requirements inspecting and onsite auditing.

• List of Medical Devices Restricted to OEM

The List of Medical Devices Restricted to OEM contains several serial of medical devices, any medical devices listed on this list, it can’t be manufactured through sub-contract production (OEM).

• List of Medical Device Testing Institute Approved by CFDA

The Medical Device Testing Institutes are nominated by CFDA directly and are responsible for the examination and evaluation of the premarket product’s safety and effectiveness in the record or registration procedure. Based on the “Regulations for The Supervision and Administration of Medical Devices”, CFDA enacted the “Qualification Determination for Medical Device Inspection Institute”. There are 31 qualified Medical Device Testing Institutes in China, and each testing Institute has its own unique expertise. Any medical devices registration should be performed the registration test (technical requirement partial) and biological evaluation before submitted to CFDA.

• List of Clinical Trial Institute for Medical Devices

The clinical trial institute for medical devices are nominated by CFDA and former accredited in accordance with the GCP for drug. CFDA has promulgated the specified GCP for medical devices under the new medical device regulations (Decree No. 650). Generally, any medical device not listed on the “Catalog of Medical Devices Exempted from Clinical Trials”, it will be required to conduct clinical trial in the CFDA designated clinical trial institute in China.

• Catalog of Medical Devices Standard

Any medical device registered in China, it’s required to comply with the China national standards or industry standards, and to be compiled the document of technical requirements according the Chinese standards. Even if you have got the medical device registration certificate, you are required to rectify the technical of your product once the Chinese compulsory standards updated, it is mandatory.
If you would like to get the English version of relevant Chinese standard, please contact Ms. Windy Jing | Windy@cirs-group.com.

• List of high risk medical devices

The high risk devices are screened based on the “The Management Measures for Imported Medical Device Inspection and Supervision”. It is divided into three classes: A, B, C according to the risk level. Class A refers to the medical devices with extremely high risk, and the product cannot pass the customs unless complete the inspection and the product is qualified. Class B refers to the high risk medical devices with risks controlling. The product must be sampling inspected after pass the customs, and cannot go on sale unless the product is qualified. Class C refers to the high risk medical device with controllable risks.

• List of Medical Devices need to be approved prior to Clinical Trial

Some higher risk medical device are required to be approved by CFDA prior to clinical trial, it is designated by CFDA to ensure the safety during clinical trial. if the Chinese legal agent and the clinical trial institute is in different province, they are required to report to the local FDA where the Chinese legal agent located.