Regulatory Affairs

In the registration dossier CH3.5.01, it is required to provide the basis for determining the performance indicators in the Product Technical Requirements (PTR). The manufacturer shall provide the Verification and Validation Report instead of the factory inspection report. NMPA reviewers often ask the applicant to explain how the performance indicators were defined in the PTR during the supplementary phase. To avoid such issues, BradyKnows will refer to both Chinese standards and the client’s V&V reports while drafting the PTR to ensure that the performance indicator is compliant and retrievable.Takeaway: The performance indicators listed in the PTR could be considered during type testing, hospital bidding, random national inspection, and even be referenced by the stability study reports in the research materials.

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When using self-testing report to replace a type testing report, the following requirements need to be considered: Make sure that the self-testing report refers to the current Chinese standards that are acceptable by the NMPAThe lab where the self-testing will be conducted should possess the corresponding qualifications, tools, and personnel per NMPA requirements and guidelines.On July 23, 2021, the China NMPA issued the further modified draft guidance on the Self-testing of Medical Devices for China Registration based on previous comments collected from the public. NMPA is now releasing the second draft guidance for public opinions. The final version of the guidance has not been released yet. Takeaway: It is recommended to perform self-testing at your local laboratories with the help of consultants who are experts in running type-testing in China. There are a lot of details to consider making sure your self-testing reports are compliant with NMPA requirements.

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Registration strategy is a roadmap to the success of NMPA approval. It relies heavily on the input information provided by the manufacturer and the experience of the consulting company from the perspective of the registration process, cases of similar products approved in China, the mastery of past and current regulations, and the judgment of new policies. A qualified consulting company should help clients find a balance between the client’s needs and NMPA requirements at the strategy phase, such as the registration unit, indication, clinical requirements/pathways, standards, testing requirements, and any potential risks along with the registration. The consulting company shall also be able to communicate with the NMPA reviewer on behalf of the manufacturer.Takeaway: Some consulting companies only provide a simple quotation disguised as a registration strategy, which will be revised or even overturned in the later registration process.

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China NMPA requires medical device manufacturers to provide the product lifetime or shelf-life and related research material to support such claims.For active medical devices, the lifetime can be determined by key component test, whole machine test, post-marketing experience data, or choose the most suitable one for your product.For passive medical devices, the shelf life can be determined by real-time or accelerated aging tests. In the test, we should use three batches of products and pick three checkpoints. At each checkpoint, tests from the Product Technical Requirements (PTR) should be performed to examine the product’s performance.Takeaway: Currently, it is unlikely to obtain NMPA approval without providing the lifetime or shelf-life research materials.

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Active medical device consumables can be registered independently. In most of cases, commonly used consumables should not be included in the registration unit and are not included in the registration unit. For consumables of particular use, we need to refer to relevant NMPA guidance.Takeaway: Medical device consumables in the same sterile packaging might be registered as one single registration unit.

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Smallest sales unit and registration unit are two different concepts. As part of the registration dossier, NMPA requires manufacturers to provide the label sample of the smallest sales unit. We usually need to modify the label as per NMPA requirements.Takeaway:NMPA has a guideline for the determination of a registration unit for medical device registration. Do not confuse the concepts of the smallest sales unit with the registration unit.

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In China, combination products are defined as a single entity that consists of both drug and medical devices. If the medical device plays the leading role, it will be classified as a device-based combination product. Otherwise, it will be classified as a drug-based combination product. NMPA has issued a draft guideline for the registration review of Device-based combination products. It is also recommended to submit a request to NMPA to get the official classification for your combination product.Takeaway: The drug part of the device-based combination product should be already approved in China.

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When you submit the registration dossier to NMPA, the reviewer will perform a preliminary review. You will likely receive a pre-submission supplementary notice at this stage. It is also expected that you will receive several pre-submission requests until the reviewer thinks you are eligible for official submission acceptance. There is no due date for addressing the pre-submission requests. After official acceptance, you need to pay the application fee, and the first-round technical review will be performed. After several months, you will receive post-submission supplemental notice from the reviewer, for which you will have one-year time limit to address all the issues.Takeaway: The reviewer who performs the pre-submission review is the same reviewer for the official technical review. As per NMPA statistics, an applicant receives 2.73 pre-submission supplemental notices on average.

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