Export concerns: foreign access requirements for medical devices

medical instruments 

Medical devices are products closely related to human life and health, and countries all over the world attach great importance to the development of the medical device industry. In recent years, with the implementation of the "supply-side reform" strategy of my country's economic development, the development of the medical device industry has been included in the national development strategy. The medical device industry has entered a period of rapid development, gradually entering the international medical device industry, and gradually transforming from a major consumer country It is a major manufacturing country and a major exporting country.

With the increase of global public health awareness, medical service organizations have continuously increased their requirements for high-quality medical devices. Governments of various countries have formulated corresponding laws and regulations to improve the safety of medical devices to protect the lives of people.

Therefore, when my country’s medical device industry goes abroad, it is necessary to understand the laws and regulations of relevant countries, and to know the corresponding regulatory requirements and the direction of market demand, and to adopt corresponding strategies and measures in a targeted manner, steadily advancing, and continuously improving product performance. Energy level, and gradually expand overseas markets. In this issue, the editor has compiled the access requirements of China's major exporting countries and regions for medical devices for your reference.

1. Definition of medical devices
Medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials and other similar or related items used directly or indirectly on the human body, including the required computer software.
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2. Customs tariff number and name of common medical device products
Export Concern: Medical Device Foreign Access Requirements Export Concern: Medical Device Foreign Access Requirements


3. Classification and requirements of major countries and regions

▷U.S. FDA
Export Concern: Medical Device Foreign Access Requirements Export Concern: Medical Device Foreign Access Requirements

The U.S. Food and Drug Administration (abbreviation: FDA) is responsible for ensuring the safety of food, cosmetics, drugs, biological agents, medical equipment, and radiological products produced or imported in the United States. It is also responsible for enforcing public health conditions and interstate Inspection of travel and transportation, control of diseases that may exist in many products, etc.
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• Classification
The range of medical devices is very wide, ranging from medical gloves to cardiac pacemakers. They are all under the supervision of the FDA. According to the medical use and possible harm to the human body, the FDA classifies medical devices into categories I, II, and III. The higher the supervision, the stricter.

The first category (low to moderate risk): general management. Refers to products with little or no risk.

The second category (moderate to high risk): ordinary + special management. Its management is based on "ordinary management", but also through the implementation of standard management or special management to ensure quality and safety effectiveness.

The third category (high risk): Pre-market approval management (PMA). Refers to products that have a higher risk or hazard, or support or maintain life, such as artificial heart valves, pacemakers, artificial lenses, artificial blood vessels, etc.
• Access requirements

For Class I products, after the company submits relevant materials to the FDA and passes the review, the FDA only makes an announcement, but no relevant certificates are issued to the company;

For Class II and Class III devices, companies must submit PMN or PMA. The FDA will issue a formal market access approval letter (Clearance) to the company at the same time of the announcement, that is, allow companies to sell directly on the US medical device market in their own name Its products. As for whether to go to the company for on-site GMP assessment during the application process, the FDA will decide based on comprehensive factors such as product risk levels, management requirements, and market feedback.
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▷ European Union CE

In order to regulate its market and unify product standards and specifications, the EU stipulates that the "CE" mark is a mandatory certification mark in the EU market. Whether it is products produced by EU enterprises or other countries, if they want to circulate freely on the EU market, they must add Affix the "CE" mark to show that the product complies with the basic requirements of the EU "New Method of Technical Coordination and Standardization" directive. This is a mandatory requirement of EU law on products. Medical devices exported to the EU cannot be cleared without CE certification.

Export Concern: Medical Device Foreign Access Requirements Export Concern: Medical Device Foreign Access Requirements
• Classification

According to the new EU medical device regulations "Medical Device Regulations" (2017/745, MDR) and "In Vitro Diagnostic Devices Regulations" (2017/746, IVDR), medical devices in the EU are now only divided into two categories: medical device MD and In vitro diagnostic equipment IVD.

According to the declared intended use of the product, if the product is invasive or touches the skin, it belongs to the medical device MD under the jurisdiction of MDR; if it is non-invasive or does not touch the skin at all, it belongs to the in vitro diagnostic device under the jurisdiction of IVDR IVD.

According to the "Medical Device Regulations" (MDR), medical devices MD are classified into categories I, IIa, IIb, and III according to their risk levels.

Export Concern: Medical Device Foreign Access Requirements Export Concern: Medical Device Foreign Access Requirements

According to the "In Vitro Diagnostic Device Regulations" (IVDR), IVD in vitro diagnostic devices are divided into four categories: A, B, C, and D according to the risk level from low to high.

• Major changes in the new regulations

One is to upgrade the directives to regulations at the regulatory level;

Second, the two medical device regulations replaced the previous three medical device directives;

Third, the classification rules for in vitro diagnostic devices have changed significantly.

The two new regulations promulgated by the EU in 2017 took effect in 2017, but have a certain transition period, which will be enforced in May 2021 and May 2022 respectively.
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• CE certification process

Export Concern: Medical Device Foreign Access Requirements Export Concern: Medical Device Foreign Access Requirements

▷ Australia TGA
The Australian Medicines Agency (TGA) is the regulatory agency for Australian medical supplies, responsible for a series of assessments and supervision to ensure the quality and quantity of Australian medicines. The scope of products regulated by TGA includes medicines, medical devices, blood and blood products.

• Classification
Australia divides medical devices into five major categories according to the degree of risk they pose. The higher the classification level, the more demanding.

Export Concern: Medical Device Foreign Access Requirements Export Concern: Medical Device Foreign Access Requirements

• Access procedures
1. If the medical device is manufactured overseas (ie Class I disinfection; Class I measurement; Class IIa; Class IIb, Class III, AIMD)

1. The manufacturer obtains conformity assessment evidence from TGA or EU certification bodies;

2. The manufacturer prepares the Australian declaration of conformity;

3. The sponsor submits the manufacturer’s evidence to TGA;

4. The sponsor submits an application for registration with ARTG;

5. The organizer can supply equipment in Australia after registration with ARTG;

6. Continuous monitoring of devices after they are on the market.
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2. If the device contains a drug or animal material, microbial or human origin (i.e. Class III and AIMD):

1. The manufacturer decides on the quality regulations to demonstrate that the device complies with the relevant basic principles and prepares the necessary documents;

2. The manufacturer applies for TGA conformity assessment certificate;

3. The manufacturer prepares the Australian declaration of conformity;

4. The sponsor submits the manufacturer's evidence to TGA;

5. The sponsor submits an application for registration with ARTG;

6. The organizer can supply equipment in Australia after registration with ARTG;

7. Continuous monitoring after the device is on the market.
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▷ Canada CMDCAS

Canadian medical device access certification is CMDCAS certification, issued by the Ministry of Health, Canada implements government registration combined with a third-party quality system review. The third party mentioned here refers to a third-party organization accredited by the Canadian Medical Device Certification and Accreditation Agency (CMDCAS).

• Classification

According to CMDR (Canadian Medical Device Management Regulations) SOR/98-282, medical devices are classified into four categories: I, II, III, and IV according to their use risks. For example, Class I devices are the lowest risk, and Class IV devices are the highest risk. . For this reason, the product registration requirements for manufacturers have also been gradually increased, and the system that manufacturers are required to implement is more and more detailed.

• registration process

Class I:

1. Prepare the corresponding technical documents for applying for MDEL (Canadian Medical Device Business License);

2. Submit the MDEL application and pay the administrative fees of the Ministry of Health;

3. If the application is approved, it will be announced on the Health Canada website.

Class II, III, IV:

1. Carry out ISO 13485 audit certification through a certification body accredited by CMDCAS (system audit should include special requirements of CMDR in addition to ISO13485 requirements) and obtain a certificate;

2. Prepare MDL (Canadian Medical Device License) application;

3. Submit the MDL application and pay the administrative fees of the Ministry of Health;

4. Health Canada reviews the MDL application and publishes it on the website after passing the review.
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In addition, Canada also needs to review Premarket review documents for Class III and IV medical devices.

▷ South Korea KFDA

The Ministry of Health and Welfare of South Korea, referred to as the Ministry of Health, is mainly responsible for the management of food, medicine, cosmetics and medical equipment, and is the most important health care department.

According to the "Medical Devices Act", the Ministry of Food and Drug Safety under the Ministry of Health and Welfare of Korea is responsible for the supervision of medical devices.

The Korean Medical Device Law divides medical devices into 4 categories (Ⅰ, Ⅱ, Ⅲ, Ⅳ), and the degree of risk increases from Ⅰ to Ⅳ, namely: Ⅰ is a medical device with almost no potential danger, and Ⅳ is a high-risk medical device. medical instruments.
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• Classification

Class I: Medical devices with almost no potential dangers;

Class Ⅱ: medical devices with low potential risk;

Class III: Medical devices with moderate potential hazards;

Category IV: High-risk medical devices.

• registration process
1. Determine the product category (I, II, III, IV) and select KLH (Korean certificate holders, companies not in Korea need to choose a Korean certificate holder, usually a distributor in Korea);

2. Type II products need to apply for KGMP certificate and accept on-site audit. Type II products are generally authorized third-party auditors and obtain KGMP certificates;

3. For Type II products, samples need to be sent to a laboratory authorized by South Korea's MFDS for South Korean standard testing;

4. KLH submits technical documents (test report, KGMP certificate, etc.) to MFDS for registration approval;

5. Pay the application fee;

6. Rectification of registration documents and registration approval;

7. Designate Korean agents and distributors for product sales.
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