Being in accordance with the regulations of China Food and Drug Administration (CFDA), any medical device manufacturer seeking to market their product in China must appoint a local registered legal agent and after-sales service agent to handle the regulatory affairs in China. This is mandatory if you have no China office. The local registered legal agent and after-sales service agent are known as China Authorized Representative (CAR).
Who are qualified to act as your CAR?
Your China Authorized Representative must have a valid business registration, full range service and local residence in China. CIRS is a company duly incorporated and validly existing under the laws of Republic of China with a subsidiary office in Ireland. It has a sufficient background in the practical handling of regulatory affairs of medical device in China. CIRS provides full range of regulatory compliance services for Medical Devices and is qualified for acting as your China Authorized Representative under the laws and regulations of CFDA.
What is the obligation of your CAR?
Having an independent, professional CAR is important to ensure that your regulatory obligations are being met in China. We, CIRS perform all duties that a CAR is required to fulfill and provide three local representative service options upon your request:
Option 1: Medical devices registration agent
CIRS act as your local agent for product registration to assist with you to manage the medical devices registration and finally obtain the registration certificate from CFDA, the work scope of a registration agent are:
- CIRS act as your primary contact point to liaise with CFDA and related authorities;
- Confirmation of the product managed category, regulatory obligations and other requirements;
- Preparation of the required documents in full cooperation with you or your local distributors;
- To coordinate with related institutes or authorities to ensure in scheduling inspections, clinical trial and technical review;
- Compiling and correcting the product standards, instructions, labels and packaging marks;
- To submit the application and obtain the certificates for each medical device from CFDA;
- CIRS protect the confidentiality of client’s documentation and other business information.
- CIRS assist with procurement of renewal registrations (every four years)
Option 2: After-sales service agent
CIRS act as your primary after-sales service agent to handle the post-marketing regulatory affairs and assist with you to find the specific service agent in China, the work scope of a after-sales service agent are:
- CIRS serve as your communication liaison with the local customers and authorities
- CIRS monitor the information of product defects, adverse event, and customer complaints, and raise the proper solutions or report to the proper authorities.
- CIRS assist with you to recall the medical devices which have quality defects.
- Adverse events monitoring and reporting it to the proper authorities.
- Premarket and post-market investigation reporting.
- Assist with you to promote the product and find local distributor.
Option3: China legal representative
Foreign manufacturer can setup subsidiary or branch office in China, designate agent to act as your China legal representative to handle the all regulatory affairs in China, their obligations in legal are:
- Liaise with the medical devices registration management authorities and the overseas applicant.
- Post-market adverse events monitoring and reporting.
- Post-market medical device recall
- Undertake the legal obligations same to the overseas applicant to guarantee the product quality and after-sales service.
Please note that the identification of China legal representative must be printed on the labels of medical device according to the Regulations for the Supervision and Administration of Medical Devices.