By kingandwood Mallesons’ Healthcare Group
On 31 March 2014, Chinese government released the revised Regulations on the Supervision and Administration of Medical Devices (“Revised Regulations”). The Revised Regulations will come into effective on 1 June 2014, presenting following major changes:
Classification and Supervision System Adjustment
According to the Revised Regulations, medical devices are still supervised and managed under a Class I, Class II and Class III system based on the risk to the users. However, the supervisory system has been changed with below highlights.
- Medical Device Rregistration/Filing
Class I medical devices no longer need a prior registration and a record-filing with the relevant municipal FDA is sufficient. Class II and III medical devices still require a prior registration but for subsequent changes, only a record-filing instead of previous registration modification is required if such changes are non-substantial.
- Clinic Trials Approval
Clinic trials of Class II medical devices no longer need a prior approval as required before. For clinic trials of Class III medical devices, the prior approval is required only for the ones accompanying high risk to human body.
- Distribution Company Approval/Filing
Class I medical device distribution company does not need to complete a record-filing as required before. Class II distribution company no longer needs a prior approval and a record-filing with the relevant municipal FDA is sufficient. Class III distribution company still needs to go through examination and approval procedures and obtain the Medical Device Distribution License.
- Other Modifications
Other main modifications include the cancellation of the approval for medical devices research and development by medical institutions, the cancellation of the compulsory safety certification requirement previously implemented for part of Class III medical devices and etc.
Manufacturing Supervision Adjustment
- Medical Device Registration before Manufacturer License
According to the Revised Regulations, manufacturers shall submit the medical device registration certificate when applying for the manufacturer license.
Although not expressly provided in the Revised Regulations, according to explanations from CDFA officials, medical device manufacturers are allowed to complete medical device registration before obtaining the manufacturing license, which means medical device manufacturers might speed up manufacturing process with a prior completed medical device registration.
However, according to the Revised Regulations, Good Manufacturing Practice (“GMP”) documents with respect to product research and development and manufacturing is required for medical device registration, it is likely that at least a preliminary GMP system shall be established at the time of registration application.
- GMP Compliance Requirement
GMP compliance requirement of medical device manufacturers is expressly provided in the Revised Regulations and medical device manufacturers must establish and operate the system, and periodically report self-evaluation results to the relevant provincial FDAs.
- Contract Manufacturing Provision
The Revised Regulations explicitly set forth an article with respect to contract manufacturing, according to which, entrusting party shall be responsible for the quality of the medical device and entrusted party shall be a medical device manufacturer that is in full conformity with the Revised Regulations and is equipped with corresponding manufacturing conditions. In addition, implantable medical device with high risks are prohibited to be produced under a contract manufacturing model.
In addition, the Revised Regulations impose more obligations on institutions using the medical devices by imposing obligation of safety management of medical devices, enhance control over daily administration and regulate supervisory activities by establishing a monitoring system of adverse event of medical devices and a re-evaluation system of registered medical devices (and etc.), emphasize liabilities by refining the penalties, adjusting the range, and increasing types and intensity of penalties for non-compliance.
After the promulgation of the Revised Regulations, Chinese government has promulgated a series of draft of relevant rules and regulations soliciting comments from public, which covers various perspectives of the supervisory system of medical devices, e.g. the management of registration and filing, supervision of production, operation and quality of use, the classification rules and etc. Together with the Revised Regulations, they will establish a new legal regime of China’s supervision of medical devices upon effectiveness. KWM lawyers will keep close attention to relevant update.