Medical device certification requirements in various countries

Medical Device Standards

These medical device standards have been widely adopted by many countries.

List of Medical Device Directives

EU directives include many basic health and safety provisions, as well as procedures for assessing the extent to which products comply with regulations. Each directive details the basic requirements in harmonized European standards established by regional standards organizations.

Therefore, manufacturers, importers, and distributors of related products must clearly indicate that the products fully comply with the health and safety regulations listed in the "Basic Requirements" of each directive.

Directives forming the basis of the "New Approach" include a wide range of product categories (horizontal directives) or specific product categories (vertical directives).

Directive Title

European Union

All products entering the EU market must have aCE mark, indicating that the product complies with the relevant directives set by the EU.

Medical devices need to meet the following directives:

Active Implantable Medical Devices Directive (AIMDD, 90/385/EEC)

Medical Device Directive (MDD, 93/42/EEC) In Vitro Diagnostic Medical Device Directive (IVDD, 98/79/EC)

Medical Device Directive (MDD), The MDD directive applies to most medical devices sold in the EU. It is divided into 6 classes according to different requirements for certification body assessment.

Unified assessment by certification bodies includes reviewing technical documents according to the basic requirements specified in the directive and reviewing quality systems according to standardsEN 46001 or EN/ISO 13485.

Since the United States, Canada and Europe generally useISO 9001, EN 4600 or ISO 13485 as the requirements for quality assurance systems, it is recommended that the establishment of quality assurance systems be based on these standards.

In Vitro Diagnostic Medical Device Directive (IVDD), The requirements of IVDD are similar to those of MDD, and can be applied according to the following classifications:

North America

In the United States, the Food and Drug Administration (FDA) is the statutory body that oversees and regulates the sale of food, drugs, cosmetics, and medical devices to consumers. The Center for Devices and Radiological Health (CDRH), a branch of the FDA, specializes in medical devices. It regulates medical devices to varying degrees according to different classes (medical devices are classified as Class I, Class II, or Class III, with Class I being the low-risk category and Class III being the high-risk category):

In Canada, the Canadian Medical Devices Conformity Assessment System (CMDCAS) requires medical device manufacturers to obtain a quality system review from a CMDCAS-accredited third-party organization, such as UL, in advance to demonstrate that their quality system complies with the CMDCAS ISO 13485 and ISO 13488 standards. Understanding CMDCAS certification is very helpful in completing FDA quality system registration (QSR), as the QSR, as mentioned above, is based on ISO 9001 and ISO 13485 standards. Most medical devices belonging to Class I or Class II require 510(k) or premarket notification; only low-risk Class I devices are exempt from 510(k)

The FDA requires that medical devices ready for market must have the same safety and effectiveness as substantially equivalent devices (referring to devices already approved for market sale). Therefore, manufacturers need to provide reports detailing the comparison of their products with similar products on the market. Manufacturers are responsible for obtaining and verifying information related to substantially equivalent devices, such as catalogs, instructions for use, and other required information for 510(k).

Generally, there are three situations that require an application510(k):

① Traditional review, applicable to introducing new devices; applicable performance reports must be submitted during application.

② Special review, applicable to devices with minor modifications made according to design control procedures

③ Simplified review, submitted by the manufacturer; the manufacturer must ensure and declare that its product meets existing FDA-approved standards.

FDA 510(k) Review

FromOctober 1, 2002, onwards, a user fee must be paid directly to the FDA for review. After the initial review by the FDA, the applicant will receive a product defect report or statement from the FDA; this process usually takes 90 days. After corrections and/or supplementary materials, the FDA will conduct a further 90-day review.

To shortenthe 510(k) review cycle and reduce workload, third-party 510(k) review is another option for completing the review. If you choose a third-party review organization such as UL, the entire review can be completed within four weeks.

Asia

The Asian medical device market is one of the markets with the greatest development potential. With the improvement of quality of life and health awareness, Asian consumers are more willing to spend on health products than before.

Japan

Medical devices have the largest consumer markets in Japan, China, and South Korea. In Japan alone,sales of medical devices reached US$23 billion in 2001.

Japan's healthcare system is completely different from that of the United States. The Japanese government has established a strict product certification process that all new foreign medical device products entering the Japanese market must strictly adhere to. To enter the Japanese market, medical product manufacturers must first obtain two documents issued by the Japanese Ministry of Health, Labour and Welfare (MHLW) -- a business license and a marketing authorization.

Foreign manufacturers must entrust an agent who has already obtained a business license in Japan. The foreign company and the Japanese agent are jointly responsible for the import procedures and documents applicable to their products,GMP standards, and post-market surveillance certification.

In Japan, products are classified into3 categories according to different risk levels (from low to high). UL provides Type Testing services to customers based on Japanese domestic standards such as JIS T1001 and JIS T1002.

China

China's National Medical Products Administration (CFDA) plays a role equivalent to that of the FDA, responsible for the registration and supervision of imported medical devices. In addition, other agencies of the Chinese government have the authority to adjust the relevant regulations governing certain medical devices. The State Drug Administration manages the inspection and quarantine work at customs, such as issuing safety permits for medical optical instruments, dialysis machines, blood purification devices, electrocardiographs, implantable cardiac pacemakers, and ultrasound instruments.

WithChina's accession to the WTO, China has begun to implement mandatory certification for both imported and domestic products. To meet the requirements of standardization, the corresponding medical device regulations are also undergoing significant changes. These changes include the comprehensive standardization of product classification, product safety assessment methods, certification marks, and certification fees. From August 1, 2003 (originally scheduled for May 1, 2003), the China National Accreditation Service for Conformity Assessment will implement mandatory certification, namely CCC certification, for some high-risk medical devices, officially replacing the previous China Electronic Equipment Safety Certification Certificate, namely CCEE certification, and the China Import Commodity Safety Quality License, namely CCIB certification. In China, manufacturers can apply for CCC certification directly or through an authorized agency.

South Korea

All medical devices sold in South Korea must obtain a domestic product production and sales license issued by the Korea Food and Drug Administration (KFDA) in accordance with its Pharmaceutical Affairs Act. The Korea Food and Drug Administration is directly managed by the Ministry of Health and Welfare (MOHW). Currently, the only way for foreign manufacturers to obtain a sales license is to apply through an importer in South Korea. Licenses are specifically classified into the following levels:

（1) Class I - Premarket Notification

（2) Class II - Marketing Authorization (including Model Testing);

（3) Class III - Marketing Authorization (including Model Testing and safety performance evaluation);

Importers of Class II and Class III medical devices must submit relevant product technical data to the KFDA, equivalent to the data required when applying for premarket notification and/or premarket approval to the FDA. For some Class II products, safety and performance testing is required, and sometimes clinical tracking is also required. The law stipulates that production license applications must be reviewed within 55 days of the date of submission. Recently, South Korea has accepted the concept of third-party review, and entities accredited by the KFDA can now complete the review of Class II product production licenses, except for some radioactive instruments.

Class III products must undergo Type Testing 1 by a KFDA-accredited laboratory with testing capabilities, similar to the Type Testing 1 required when applying for marketing authorization in Japan. The test must complete the determination of product safety, electromagnetic compatibility (EMC), and performance. All these tests must be completed in the Type Testing 1 phase. And the technical data of the product should include a detailed description of the test methods and product specifications according to international standards. Foreign manufacturers can use the CB test report of the International Electrotechnical Commission (IEC) or the test report issued by a laboratory that complies with Good Laboratory Practice (GLP).

The new medical device usage law was promulgated inMay 2003, replacing the original "Pharmaceutical Management Law" and stipulating the relevant management of medical devices. The new law is very close to the FDA management system. It mainly includes legal provisions such as IDE (Investigation Device Exemption) and direct recognition of foreign manufacturers.