Machinery / Industrial Parts & Tools

background

In order to adapt to the rapid development of the medical device health industry and respond to the requirements of the era of deepening reform of the industry regulatory system, on February 9, 2021, the Premier of the State Council signed the State Council Order No. 739 and passed the "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the new " Regulations), which will be officially implemented on June 1, 2021.

The new "Regulations" take leniency, strict management, and heavy penalties as the main principles of the amendment, emphasizing the main responsibility of the enterprise, in product registration, device production, clinical trials, device operation, quality system, adverse events, industry innovation and legal responsibilities. In this regard, various degrees of revision have been made.

Changes in the old and new "Regulations"

Excerpted from Article 14 of the New "Regulations":

For product inspection reports that need to be submitted for product registration, “the first-class product inspection report may be the self-inspection report of the filing person (Article 10). The second- and third-class product inspection reports shall be medical The inspection report issued by the device inspection agency (Article 11)." is changed to "the first, second, and third product inspection report can be the self-inspection report of the medical device registration applicant, the filing person, or the entrusted qualified The inspection report issued by the medical device inspection agency."

At the same time, the main responsibility of the enterprise is emphasized. The enterprise must have the ability of self-inspection and the corresponding quality system management ability, and be responsible for the quality and results of the inspection report.

Medical device registration self-inspection requirements

In order to further clarify the provisions on the self-inspection of enterprise product registration in the new "Regulations", the State Drug Administration recently issued another "Regulations on the Self-inspection of Medical Device Registration" (draft for comments) (2021.7.23), hereinafter referred to as "Regulation".

It is not difficult to see from the above:

1. The "Regulations" have high requirements on the self-inspection capabilities of enterprises. There are strict on-site inspection requirements for personnel, equipment and environmental facilities, samples, inspection quality control, and record control.

2. The "Regulations" have very strict requirements on the company's quality system management capabilities. Need to meet the relevant requirements of ISO 17025 related to medical device inspection capabilities.

This means that if a company wants to register and submit a self-inspection report, it must have the corresponding self-inspection capability and establish a corresponding quality management system. The investment is large, the maintenance cost is high, and self-built laboratories obviously need to bear great risks. Therefore, small and medium-sized enterprises entrust a qualified medical device inspection agency to issue an inspection report that is more cost-effective.

How to choose a medical device inspection agency

With the country's liberalization of third-party inspection agencies for medical devices, more and more inspection agencies have participated in the ranks of medical device product services, resulting in uneven service quality. Enterprises can choose service organizations from the following three aspects:

Check qualifications.

According to Article 75 of the new "Regulations", the inspection agency selected by the manufacturer must have the national CMA qualification accreditation.

Official inquiry website of national CMA qualification: http://cma.cnca.cn/cma/solr/tBzAbilitySearch/list

Check the scope of capability.

The scope of authorization of inspection agencies that have obtained the national CMA qualification is different. Manufacturers must ensure that the authorized scope of their CMA covers the technical requirements of their products.

Assess service capabilities

With the rapid development of the medical device industry, for small and medium-sized manufacturers, their product solutions are often not complete and the technology is relatively immature. In the domestic registration inspection, the testing capabilities of the inspection agency, the ability to find and solve problems, and the legal services Ability dependence is strong. An experienced inspection agency with good service quality can greatly reduce the period required for products to enter the market and win market opportunities for enterprises.

The strength of CCIC Huatongwei

CCIC Huatongwei is a professional medical device inspection agency under CCIC Group. It is a "one-stop shop" integrating medical device product testing, domestic registration/certification, global technical and regulatory consultation, clinical verification, system certification, and self-inspection capacity building. "Medical equipment product quality service platform. It is also the only central enterprise specializing in inspection, inspection and certification.