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The pathway from product design to product launch for a new medical device is often unclear and the number of challenges and questions often increase as medical devices become more complex. Generally, medical device regulations are based on risk. Our regulatory consultants have the expertise to help your medical device meet the many challenges of the approval process, for products distribution in China.

Our consultants are well respected by the SFDA and Ministry of Health regulatory bodies and have an excellent rapport with regulatory agency leaders and reviewers earned through years of professional experience. With Airtrust as your partner, you will gain a deep understanding of the regulations and requirements applicable to your medical device, often beyond what is available in published guidance documents and other materials.

We will work with you to design and implement a competitive and cost-effective regulatory strategy, prepare and submit a "reviewer-friendly" marketing application, and serve as your liaison from start to end, helping you to prepare the necessary documentation, respond to questions and negotiate with regulatory agencies quickly and effectively.

A well-crafted regulatory strategy considers SFDA medical device regulations, but also development costs, development cycles, and profitability concerns. Airtrust will consider the current regulatory environment, relevant guidelines, and ongoing SFDA and/or international medical device initiatives that could influence your regulatory pathway. Our goal is to facilitate a timely, competitive, and successful product clearance or approval.

We will consider information about your medical device, including, the device description and specifications, its intended clinical applications and labeling claims, available test data, and any literature references. We will also review information about possible predicate devices that may be similar to yours, along with standard methods, procedures and/or practices, SFDA guidance documents, and other medical device regulations and policies that could apply to your product.

Our consultants and project managers are well respected by the SFDA and other regulatory agencies. Airtrust staff has excellent rapport with agency leaders and reviewers, earned through years of professional experience and almost daily interactions. With Airtrust as your partner, you will gain a deep understanding of the relevant medical device regulations often beyond what is available in published materials, directives, and FDA guidance documents.

Our goal is to provide you with a clear understanding of the types of regulatory and clinical trial requirements you will encounter as you work towards launching your medical device in CHINA. We will define a strategy that will move your device along the appropriate pathway more easily and reduce the cost and time to bring your innovation from the bench to the bedside – and meet your ultimate goal of bringing safe and effective medical technology where it is needed, to the patient.

Depending upon the classification of your device and your current stage in the medical device development process, there are a variety of medical device submissions that may be required by the SFDA.

Airtrust will work with your team to review, prepare and submit a "reviewer-friendly" document, designed to effectively address SFDA concerns and minimize additional questions. Airtrust will assist to prepare and submitted the following documents:

The certificate of the legal production qualification of the Manufacturer
The qualification certificate of the applicant
The certificate recognized or approved by the government of the Country (Region) of Origin to authorize the products as medical devices to enter into the market of the country
The Standards of the Products to be Registered shall apply the Provisions for the Management of the Medical Devices Standards
Operation Manual of the Products
The Type test Report presented by the medical devices quality test agency recognized by the State Drug Administration within the recent one year (Applied to the Products of Class II and Class III)
The clinical trial report of medical devices, the methods on the provisions of the report should be applied in accordance with the "Provisions for the 'Subitem of Clinical Reports' for the Registration of Medical Devices". The clinical trial shall be implemented in accordance with the "Provisions for the Clinical Trial Management of Medical Devices"
The Product Quality Guaranty presented by the Manufacturer, to promise that the quality of the products registered and sold in China are unanimously the same as that of the identical products put into market in the Country (Region) of Origin
The certificate of commission for the After-Sale Service Agency designated in China, the letter of commitment and business certificate of the commissioned agency
The Self-Guarantee Declaration on the authenticity of the materials submitted

The majority of medical devices commercialized in the United States require a 510(k) submission, which is used to demonstrate that the medical device is at least as safe and effective, or substantially equivalent, to a predicate device, meaning a device that is legally marketed.

The SFDA receives nearly 10,000 submissions annually. The Branches and Test institutes under SFDA within these offices are organized according to medical scientific disciplines and are staffed by FDA reviewers. These reviewers, who are biomedical engineers, physicians, microbiologists, chemists, and other professionals, will determine whether a new medical device is substantially equivalent and can be marketed in China.

In general, information contained in a 510k includes a description of the device, clinical and preclinical/nonclinical performance data, device labeling and instructions for use, comparative products and/or standard methods documentation, and, if applicable, a description of any software or firmware used in the medical device will be very helpful in determine the preparation and application in China. Airtrust will help you to:

Perform a 510k like assessment to identify or confirm the most appropriate predicate device(s)
Assist to develop and prepare a written argument for "substantial equivalence" that will compare your device to a predicate device(s)
Identify any applicable FDA Guidance Documents
Communicate directly with SFDA staff and test institutes to identify any special requirements that may impact the review of your 510(k) alike documents, if necessary
Prepare and submit the document to the SFDA
Coordinate any communications and negotiations with the FDA reviewer, and prepare responses to FDA questions, if necessary

Airtrust helps clients with combination products, such as drug/device and biologic/device applications in which the primary mode of action is either the drug or biologic component, and correspondingly, the SFDA Department for Drugs or Department for Biologics will have primary jurisdiction. Airtrust can help clients identify how their particular product will likely be regulated by SFDA, and facilitate the preparation of documentation for agency review.