A comprehensive summary of medical device registration, application, and market entry requirements in China, the United States, and the European Union!!

Recently, the state has continuously issued a number of new medical device policies, aimed at promoting the rapid development of the medical device industry, improving and stabilizing the quality of medical device products, effectively preventing and controlling product risks, and promoting the effective implementation of product market access. Currently, China's medical device regulatory system is becoming increasingly perfect, and the gap with developed countries has narrowed considerably. Different countries have different requirements for the regulation and market entry of medical devices. If you want to export overseas, you must comply with the national medical product access regulations of the importing country. Today, we will take the United States, the European Union, and China as examples to understand the management models and market access requirements of different countries.

Management Model

 

United States

 

Adopts a pharmaceutical management model

 

The United States was one of the earliest countries to begin regulating medical devices. The core of the US medical device management system is the Food, Drug, and Cosmetic Act (FDCA), which is characterized by a scientifically logical pharmaceutical management model; its breakthrough lies in being the first to simultaneously propose pre-market and post-market supervision of products, and establishing a medical device classification and management system based on product risk, classifying more than1,700types of medical devices into three categories for management.

 

FDA’s medical device management model can be summarized as follows:

 

Based on a product classification and review principles database; proposes a comprehensive definition of medical devices, providing a basis for defining medical devices and distinguishing between drugs and medical devices; proposes a risk-based medical device classification system and the concept of market access; supervises medical device manufacturers' compliance with regulations; requires manufacturers and users to provide feedback on the use of medical devices; employs a centralized and expert-supported approach to managing medical devices.

 

European Union

 

Strives to achieve coordination

 

As the world's second-largest producer and consumer of medical devices, the EU has a long history of medical device management and valuable experience worth learning from. With the promulgation of the EU Single Market Treaty, the unified and coordinated European Medical Device Directive (MDD) was officially published in1993year, aiming to eliminate trade barriers, achieve mutual recognition, and coordinate technology within EU member states.

 

MDDIt is one of the most important relevant legislative instruments in the EU, aiming to achieve consistency of laws within the EU. As part of the single market plan,MDDestablishes a unified regulatory system for the management of medical devices in the EU, mainly consisting of directives on active implantable medical devices, medical devices, and diagnostic reagents3directives.

 

MDDIt is also the most influential medical device regulation to date, implemented in all EU member states and achieving good results. This directive is considered a model that embodies the globalization of medical device regulations.

 

This directive introduced the following new concepts:

 

Classifying medical devices into four categories according to classification rules, each following different conformity assessment procedures; management of combination products of drugs and medical devices; setting out basic requirements as fundamental conditions for ensuring the safety and performance of medical devices, and using medical device standards to refine the technical specifications of products; requirements for risk assessment of medical devices; requirements for clinical data related to the safety and effectiveness of medical devices; the obligation of manufacturers to report adverse events and to test their marketed medical devices; the concept of third-party review institutions, implementing decentralized management.

 

China

 

Laws and regulations are gradually improving

 

Relatively speaking, the establishment of medical device regulations in China started later. Although1991year was when the first governmental regulation on medical devices was issued, it has since maintained a good momentum of rapid development and continuous improvement.

 

Overall, the requirements for medical device management in China can be summarized into three points:

 

Pre-market management of medical devices is divided into three stages (namely, medical device product registration application, production enterprise license application, and medical device operation management or self-operated bidding), adopting a compulsory licensing system; corresponding to pre-market access for medical devices, medical devices also face post-market management and control, the main methods being quality supervision spot checks and license inspections; currently, the management of medical device quality systems and post-market management are in the initial stages of legislation, and there is a lack of experience; a combination of centralized and decentralized regulatory models is adopted, with decentralized management for low-risk products and centralized management for high-risk products.

 

Market Access Model

 

United States

 

Medical devices are classified into three categories according to their risk level,93%Iclass and9%IIclass devices510(k) exempted products do not require substantive technical review.7%IClass (510(k)81%IIClass (510(k) devices and a small number ofIIIclass regulations are general controls and special controls, pre-market notification, which is commonly referred to as510(k)510(k) The prerequisite for application is that similar products have already been legally marketed in the United States.IIIClass medical devices are subject to general controls and pre-market approval (PMA). ForI、IIandIIIclass products, manufacturers need to register their companies and list their products.

 

FDA 510(k) process

 

1.According toFDAregulations, determine whether the device is a medical device.

 

2.If eligible for small and medium-sized enterprise qualifications, the product registration fee can be reduced to half the price.FDARequires manufacturers to independently meet21CFR 820system requirements.

 

3.Classify products intoI、IIandIIIcategories. The vast majority ofIproducts and a small number ofIIproducts are exempt from pre-market notification and do not requireFDAregistration.

 

4.Regarding product market access510(k)PMAor exemption confirmation, usually510(k)

 

5.Prepare510(k) document list, prepare and review the documents.510(k) divided intotraditional，specialandabbreviation。

 

6.Submit documents toFDA，generally within1-2months, a review opinion will be issued, and the license will be approved within3-6months.FDAThe number of times formal questions are raised shall not exceed2times, and a response is required within the specified time limit. Otherwise, the registration will be deemed unsuccessful. Applicants may also apply for a six-month extension, and failure to respond to questions after the extension will also be deemed as registration failure.

 

7.After passing510(k) licensing,FDAthe product andKnumber information will be published in the database, and it can be queried by anyone.

 

8.510(k) After passing,FDAa formal license letter will be sent to the applicant, only one copy. After receiving the license letter, the manufacturer needs to complete the enterprise listing and product registration on the website.

 

9.After completion, if the product involves major changes, a change application needs to be submitted. The process restarts, and a newKnumber is assigned after completion.

 

10.Manufacturers need to pay annual fees toFDAto renew the registration annually.

 

Most Class III devices, and Class I and Class II new devices, if determined not to be“substantially equivalent”to similar devices currently on the market, must undergo pre-market licensing application, review, and approval before they can be marketed, i.e.PMA。PMAThe application does not need to be compared with any products on the market. It mainly proves that the new product is harmless to the human body and can achieve the expected effect.

 

European Union

 

The competent authorities of the EU member states authorize third-party notified bodies to be responsible for review and supervision. Medical devices can be marketed in EU countries, which means that the device meets the basic requirements of the relevant directives within the EU and can be legally used.CEmark, and has completed the conformity assessment procedure, and can be legally placed on the market in EU member states.

 

All medical devicesIIaclass and above pre-market review are carried out by third-party notified bodies in accordance with the relevant directives.IClass products do not require notified bodies to be involved in pre-market approval, and the manufacturer can legally use the93/42/EECdirective to issue a declaration of conformity and legally use theCEmark. In addition, medicinal devices also need to apply to the local competent authorities.

 

Before product certification, the product classification and certification methods should be determined first, and the certification documents should be prepared. The notified body reviews the enterprise quality system and product technical documents.

 

After the initial review, the notified body will point out the problems existing in the quality system and technical documents, and the enterprise should supplement and improve the quality system and technical documents within90days. After the notified body approves, forCEproducts that have been covered by product certificates, theCEmark can be affixed,CEfollowed by the agency code.

 

CEprocess

 

1.According to the EU definition of medical devices, determine whether the device is a medical device.

 

2.Before product certification, it is necessary to authorize an EU representative to be responsible for handling product registration in the EU, handling adverse events of products in the EU market, etc.; before product certification, it is necessary to complete theISO13485quality control system certification.

 

3.Classify products intoI、IIa、IIbandIIIclass.

 

4.Confirm the certification methods for the products, generally certification under a comprehensive quality system assurance; forIproducts without measurement or sterilization requirements, a self-declaration of conformity is made.

 

5.Prepare a list of certification documents. Prepare and review the documents.

 

6.Submit to the notified body for review. Generally, it is divided into on-site review or document review. New products or new models require on-site review, and simple changes can be submitted for document review.

 

7.After the notified body approves,CEproducts that have been covered by product certificates, theCEmark can be affixed,CEfollowed by the agency code; for self-declared products,CEno agency code is required.

 

(1) Sign the “EU Representative Agreement” or “Memorandum” with the EU representative;

 

(2) Request the EU representative to register with the local competent authority and submit the registration documents;

 

(3)WEEEregistration processing.

 

8.End

 

9.In addition to renewal applications, manufacturers must undergo annual surveillance audits, including system surveillance audits and productCEcertificate surveillance audits. Fees are paid to the notified body.

 

China

 

The regulatory basis for the market entry of medical devices in China is the "Medical Device Registration Management Measures," which classifies products into three categories based on risk factors;IClass I medical devices only require registration and filing of production licenses with the municipal drug supervision and administration bureau;IIClass II medical devices require submission of registration applications to the provincial drug supervision and administration bureau, product registration testing (monitored by nationally accredited testing institutions), clinical verification (as required by regulations), and quality system assessment application;IIIClass III medical devices require submission of registration applications to the National Medical Products Administration, product registration testing (monitored by nationally accredited testing institutions), clinical verification of products (clinical exemption can be applied for if stipulated), and quality system assessment application. In addition, Chinese registration certificates differ from those abroad, having an expiration date of4years. After the expiration date, products must be re-registered to obtain a new registration certificate before they can continue to be marketed.

 

Summary

 

Due to years of regulatory experience abroad and the implementation of regulations for many years, foreign manufacturers have a deep understanding of the regulations, and therefore the execution is better. In China, many regulations have not been in place for long, and many are still under revision or consultation. Coupled with the rapid development of the medical industry at this stage, many companies do not have a deep enough understanding of the regulatory requirements, so many problems are encountered during implementation.

With the expanded pilot program of the medical device registrant system, many medical device companies can complete the registration and production of their products through entrusted services. Jincheng Biomedical Technology Co., Ltd., located in the Waigaoqiao Free Trade Zone, Shanghai, is a high-quality third-party service company that provides professional medical deviceCRO+CDMO+CSOservices. In the nearly two years since the pilot program of the medical device registrant system, they have accumulated rich experience in medical devicesCRO/CDMOand have a professional regulatory policy team to provide support for medical device companies, helping them avoid detours and providing customized one-stop solutions for different companies from product R&D to market launch.