Medical device testing and certification requirements in different countries

Medical device standard 

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

Medical device instruction list 

The EU directive contains many basic health and safety regulations, as well as the procedures for assessing the compliance of products. Each directive will specify the detailed basic provisions in the harmonization of European standards set by regional standard-setting bodies.

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

The instructions that form the basis of the "new method" include a wide range of product categories (horizontal instructions) or a specific product category (vertical instructions).

For all products entering the EU market, enterprises must have the CE mark of self-compliance statement, so as to show that the products comply with the relevant directives formulated by the EU.

The instructions that medical devices need to meet are:

Active Implantable Medical Devices Directive (AIMDD, 90/385/EEC), Medical Devices Directive (MDD,93/42/EEC) and In Vitro Diagnostic Devices Directive (IVDD, 98/79/EC).

Medical Device Directive (MDD), which applies to most medical devices that enter the European Union for sale. According to different requirements, it is divided into six grades for evaluation by certification bodies.

On April 5, 2017, the European Parliament and the Council officially issued the EU Regulation 2017/745 (MDR, EU2017/745) on medical devices, and on May 5, the official journal of the European Union officially published the regulation. On May 25th, 2017, MDR came into effect, replacing the original medical device directive (MDD, 93/42/EEC) and the active implantable medical device directive (AIMD,90/385/EEC). For details, please refer to "Introduction to the Main Changes of MDR, the New EU Medical Device Regulation"

Unified assessment of certification bodies includes technical documents according to the basic requirements specified in the directive and quality system according to the standard EN 46001 or EN/ISO 13485.

As the United States, Canada and Europe generally take ISO 9001, EN 46001 or ISO 13485 as the requirements of quality assurance system, it is suggested that the establishment of quality assurance system should be based on these standards.

In vitro Diagnostic Medical Device Directive (IVDD). The requirements of IVDD are similar to those of MDD, which can be applied according to the following categories:

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

In Canada, CMDCAS requires medical device manufacturers to obtain the quality system audit of third-party organizations recognized by CMDCAS, such as UL, in advance, to prove that their quality system conforms to CMDCAS ISO13485/ISO13488 standards. Knowledge of CMDCAS certification is very helpful to complete FDA‘s Quality System Registration (QSR), because the QSR mentioned above is based on ISO 9001 and ISO 13485 standards.

Most medical devices that belong to Class I or Class II need to obtain a 510(k) or listing notice. Only low-risk Class I devices can be exempted from 510(k). FDA requires that medical devices to be marketed must have the same safety and efficacy as those that have been approved (referring to those that have been approved for sale in the market). Therefore, manufacturers should provide reports to explain the detailed comparison between their products and similar products on the market.

It is the manufacturer‘s responsibility to obtain and verify the relevant information of the confirmed instruments, such as the catalogue, instruction manual and other information required by 510(k).

 Generally, there are three situations that need to apply for a 510(k):

① Traditional audit is suitable for introducing new instruments, and the applicable performance report should be submitted when applying.

② Special audit, applicable to instruments with minor modifications according to design control procedures.

③ Simplify the audit and submit it to the manufacturer. The manufacturer must ensure and declare that its products meet the existing FDA-approved standards.

FDA 510(k) review

 Since October 1, 2002, the user fee has to be paid directly to FDA. After the initial examination by FDA, the applicant will receive a product defect report or statement from FDA, which usually takes 90 days. After correction and/or supplement of other materials, FDA will conduct another 90-day review.

To shorten the cycle of 510(k) review and reduce the workload, the third-party 510(k) review is another option to complete the review. If you choose a third-party review body such as UL, the whole review can be completed within four weeks.

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

Medical equipment has the largest consumer market in Japan, China and South Korea. In Japan alone, the sales of medical equipment in 2001 reached 23 billion dollars.

Japan‘s health care system is completely different from America‘s. The Japanese government has formulated a strict product certification process, and all foreign medical equipment products newly entering the Japanese market must be strictly observed. In order to enter the Japanese market, medical product manufacturers must first obtain two kinds of documents issued by the Ministry of Health and Welfare of Japan (MHLW)-business license and marketing license. Foreign manufacturers must entrust an agent who has obtained a business license in Japan. Foreign and Japanese agents are also responsible for the certification of import procedures and documents, GMP standards and after-sales supervision applicable to their products. In Japan, products are divided into three categories according to different risk levels (from low to high). UL provides "Type Testing" service to customers according to Japanese domestic standards such as JIS T1001 and JIS T1002.

With China‘s entry into WTO, China began to implement compulsory certification for imported and domestic products. In order to meet the requirements of standardization, the corresponding rules and regulations of medical devices are also facing significant changes. These changes include the classification of products, evaluation methods of product safety requirements, certification marks and certification fees. From August 1, 2003 (originally scheduled for May 1, 2003), China National Certification and Accreditation Supervision Committee will implement compulsory certification, namely CCC certification, for some high-risk medical equipment, officially replacing the original Chinese electronic equipment safety certification certificate, namely CCEE certification and China‘s imported goods safety and quality license, namely CCIB certification. In China, manufacturers can directly apply for CCC certification or be handled by authorized agencies.

According to the Drug Administration Law, all medical devices sold in Korea must obtain the domestic product production and sales license issued by Korea Food and Drug Administration (KFDA). Korea Food and Drug Administration is directly managed by the Ministry of Health and Welfare (MOHW). At present, the only way for foreign manufacturers to obtain sales license is to apply through importers in South Korea. The license can be divided into the following levels:

(1) class I–listing announcement;

(2) Class II–marketing license (including model test);

(3) Class ⑶III–marketing license (including model test and safety performance evaluation);

Importers of Class II and III medical devices shall submit relevant product technical information to KFDA, which is equivalent to the information required when applying for a marketing notice and/or marketing license from FDA. For some Class III products, safety and performance tests are required, and sometimes clinical follow-up. According to the law, the application for production license must be reviewed within 55 days from the date of data submission. Recently, South Korea accepted the concept of third-party audit, and now the entities approved by KFDA can complete the review of the production license of Class II products, except for some radioactive instruments.

Class III products must be "type tested" by a laboratory approved by KFDA and capable of testing, which is similar to the "type test" when Japan applies for a marketing license. Testing must complete the determination of product safety, electromagnetic compatibility (EMC) and performance. All these measurements must be completed in the "type test" stage. In addition, there should be a detailed description of the test methods and product specifications according to international standards in the technical data of the products. Foreign manufacturers can use the CB test report of the International Electrotechnical Commission (IEC) or the test report issued by the laboratory meeting the good experimental practice (GLP).

The new Law on the Use of Medical Devices was promulgated in May, 2003, replacing the original Drug Administration Law, and providing relevant regulations for the management of medical devices. The new law is very close to the FDA management system. Including IDE (Investigation Device Exemption) and foreign manufacturers‘ direct recognition and other legal provisions. 

Australia‘s five types of medical devices I, IIA, IIB, III and AIMD need the permission of TGA Therapeutic Goods Administration before they can be listed. After the manufacturer submits the application materials to TGA, TGA (Therapeutic Goods Administration) will review them according to the compliance review procedure. TGA requires the quality system of medical device manufacturers to meet the requirements of ISO13485:2003 medical device quality system. Certifying the CE certification of the European Union. TGA shall audit the manufacturer‘s quality system. Implement warning system and accident reporting mechanism for medical device products listed in Australia, and ensure that they comply with the regulations by adopting investigation reports of adverse events, laboratory inspection and monitoring activities of listed products. Sponsors and manufacturers are required to report all adverse event information to TGA.

Deeplight, with a group of powerful technical experts and research teams, keeps abreast of the latest trends and technical requirements of certification at home and abroad, and can design the optimal certification scheme for your products. The above is Deeplight introduction to the global medical device testing and certification. If you need this, please feel free to contact us for consultation!