Medical devices are an important component of the medical industry, and the safety and effectiveness of their products are closely related to our life and health. Therefore, countries around the world have established strict control systems. With the technological innovation of related industries in China and the gradual maturity of the industrial chain, the medical device industry is entering a period of rapid development, with market capacity continuously expanding and the demand for product certification increasing day by day.

However, given the diversity of certification types in the current international market and the continuous changes in laws and regulations, many medical device manufacturers are not very familiar with the content and process of product registration/certification. How to smoothly pass registration/certification is still an urgent problem that many enterprises need to solve.

1、 What is medical device registration/certification?

Medical device registration/certification is the process in which the food and drug regulatory authorities, based on the application of the medical device registration applicant, conduct a systematic evaluation of the safety and effectiveness research and its results of the medical device intended for marketing in accordance with legal procedures, in order to decide whether to approve its application.

Medical device filing refers to the submission of filing materials by the medical device filer to the food and drug supervision and management department, and the food and drug supervision and management department archives the submitted filing materials for future reference.

The medical device product registration certificate is a qualified certificate for the sale of medical device products on the market.

2、 Which products require medical device registration/certification?

Products defined as medical devices require registration/certification, typically referring to instruments, equipment, devices, machines, appliances, implants, in vitro reagents, software, or other similar or related items intended by the manufacturer for one or more specific medical purposes for human use, whether used alone or in combination. These purposes include:

Diagnosis, prevention, monitoring, treatment, or alleviation of diseases;

Diagnosis, monitoring, treatment, alleviation or compensation of injuries;

Research, substitution, regulation, or support of anatomical or physiological processes;

Support or sustain life;

Pregnancy control;

Disinfection of medical devices;

Providing medical information through in vitro examination of samples taken from the human body; Its main design function on the surface or inside of the human body is not obtained through pharmacological, immunological, or metabolic means, but these means may be involved and play a certain auxiliary role.

It is worth noting that some products can be considered medical devices in certain jurisdictions, while products that are not considered medical devices elsewhere include:

Disinfectant substances;

Assistive equipment for people with disabilities;

Instruments containing animal and/or human tissues;

Instruments used for in vitro fertilization or fertility assistance.

3、 What are the mainstream regulations for medical device registration/certification both domestically and internationally?

There are three main categories of current international and domestic regulations, namely China NMPA medical device registration, EU CE certification, and US FDA certification:

1. China NMPA Medical Device Registration/Filing

According to the Regulations on the Supervision and Administration of Medical Devices issued by the State Council of China, any manufacturing enterprise wishing to sell or use medical devices (including domestic and overseas devices) within China shall register with the corresponding food and drug supervision and administration department. According to their risk levels, they are mainly divided into three categories:

The first category of medical devices (with low risk, such as gauze, bandages, etc.) shall be subject to product filing management;

The second category of medical devices (moderate risk, such as infusion sets, surgical gloves, etc.) shall be subject to product registration management;

The third category of medical devices (higher risk, such as stents, artificial joints, etc.) require product registration management.

2. EU CE certification

In the EU market, the "CE" mark is a mandatory certification mark. Whether it is products produced by enterprises within the EU or products produced in other countries, in order to freely circulate in the EU market, the "CE" mark must be affixed to indicate that the product meets the basic requirements of the EU's "New Methods for Technical Coordination and Standardization" regulation. The EU CE certification is a passport to enter the EU market, and medical devices exported to the EU cannot clear customs without CE certification. According to the different risks of medical devices, medical devices in the EU market are divided into four categories: I, IIa, IIb, and III

Low risk medical devices belong to Class I, including:

Ordinary Class I medical devices require a CE conformity report;

Special Class I medical devices with sterile and measuring functions require a CE certificate and CE marking on the product packaging.

Moderate risk medical devices belong to Class IIa and IIb, requiring a CE certificate and CE marking on the product packaging.

High risk medical devices belong to Class III and require a CE certificate and CE marking on the product packaging.

3. FDA certification in the United States

FDA certification is a review mechanism established by the Food and Drug Administration (FDA) in the United States to ensure the safety of food, cosmetics, drugs, biologics, equipment, and radiation products produced or imported domestically. In nearly a hundred countries, including the United States, only materials, devices, and technologies that have been approved by the FDA can be commercially used in clinical practice. According to different risk levels, the FDA classifies medical devices into three categories (I, II, III), with Class III having the highest risk level, and the higher the risk level, the more supervision there will be. The FDA has clearly defined the product classification and management requirements for each medical device, and the FDA Medical Device Product Catalog has included over 1700 types of products. The types of FDA registration for medical devices include:

The manufacturer is registered with the FDA;

FDA registration of products;

Product listing registration (510 form registration);

Product launch approval (PMA review);

Labeling and technological transformation, customs clearance, registration, and pre-market reporting of healthcare devices.

4、 What are the application materials required for medical device registration/certification?

1. The following materials are required for the registration of NMPA medical device products in China:

(1) Product risk analysis data;

(2) Product technical requirements;

(3) Product inspection report;

(4) Clinical evaluation data;

(5) Product manual and label samples;

(6) Quality management system documents related to product development and production;

(7) Other necessary documents to prove the safety and effectiveness of the product.

2. The following materials are required for EU CE medical device product certification:

(1) Analyze the characteristics of the device and determine the scope of instructions it belongs to

(2) Determine the classification (risk grading) of the device

(3) Select the corresponding conformity assessment procedure

(4) Select announcement agency

(5) Confirm the applicable basic requirements/relevant coordination standards

(6) Confirm that the device meets the basic requirements/coordination standards and document the evidence

(7) Authorized representative of the European Union.

(8) Registered in Europe.

(9) For devices that require review by a notified body, the compliance procedures of the notified body shall be followed

(10) Draft a declaration of conformity and affix the CE mark

3. The following materials are required for FDA medical device certification in the United States:

(1) Determine the classification of the product. According to CFR TITLE 21 Part 862-892, most medical devices can be classified according to this classification code;

(2) Choose a US agent;

(3) Prepare Class 1 products for direct factory registration and product listing; Category 2 products require 510 (k) documents to be prepared;

(4) Submit 510 (k) documents to the FDA for document review;

(5) Register the factory and list the products.

5、 What are the difficulties and precautions in the medical certification process?

Generally speaking, there are several points to note during the medical device certification process:

One is to analyze the characteristics of medical devices, based on the definition and risk level of medical devices, combined with the expected use, structural composition, and product description of the product, to comprehensively determine the category of the product;

Secondly, based on the collection of product regulations and standards during the input stage of design and development, determine the testing basis for performance indicators in product technical requirements;

Thirdly, the conformity evaluation procedure and registration process in the medical device certification process should be selected based on the classification of the product;

Fourthly, based on the expected use and intended use of the product, the applicable population, contraindications, and adverse reactions of the product, a decision is made on whether clinical evaluation is necessary and an appropriate clinical evaluation pathway is selected;

Finally, post market supervision of medical products, such as conducting adverse event monitoring and re evaluation, is also a difficult point to pay attention to.