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China Product Certification

China Product Certification


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CFDA
China product certification introduction

The National Maternity and Perinatal Audit (NMPA) is an organization under the State Council of China, and is responsible for the management and supervision of medical devices nationwide, similar to the Korean Food and Drug Administration. Among imported medical devices in China, NMPA target products can be marketed after approval.

The National Maternity and Perinatal Audit (NMPA) was changed from CFDA to NMPA due to the reorganization of the governmental organization in March 2018. It stipulated that health food (health functional food in Korea) is managed and supervised by the National Market Supervision and Administration Bureau.

NMPA can be seen as CFDA in the past and is currently divided into two organizations, but for convenience, it is collectively referred to as NMPA.

What is NMPA registration?

    It refers to the registration process in which the product lines included in the following items are certified by the Chinese NMPA according to Chinese regulations.
    ❁ Medical devices (including in vitro diagnostic devices)

    ❁ cosmetics

    ❁ Raw materials and ingredients for pharmaceuticals and pharmaceutical packaging materials

    ❁ infant formula

    ❁ Health food (nutrients and special dietary supplements)

    ❁ Food for special medical purposes The NMPA certification is a system introduced so that it can match international requirements as international competition intensifies after identifying institutional gaps as China faces globalization.
    Import, sale and use of the above products are permitted only with valid NMPA certification for quality assurance and product safety.

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NMPA related regulations

    The ever-changing laws and increasing regulatory requirements make the application process complex and difficult, not only for first time applicants, but also for companies with extensive application experience.
    This is because the laws related to NMPA certification for certain product lines have been introduced only recently and are constantly being revised.

    NMPA registration rules are similar to international standards.
    ❁ GB standard (national standard)

    ❁ YY standard (industry standard)

    In particular, the guidelines for labeling health food warning phrases are scheduled to be implemented from 2020, so health food must indicate the warning phrase, production date, and quality guarantee period on the minimum packaging (container). In addition, the number of health foods subject to the registration system is expected to increase as the health food ingredient list and health function list management method are implemented.

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What is SAMR?

    ❂ On March 13, 2018, at the 13th National People's Congress, the Chinese Cabinet decided to reduce the number of ministries at the ministerial level, and the related regulations and officials in charge of registration were to remain the same.

    ❂ “Health food” in China refers to foods that can supply nutrients to specific or general consumers or control body functions, and are foods that are not intended for treatment and do not have acute or chronic harm to the human body. SAMR health food license and registration is an essential gateway to export health food to China. Only health food approved by the National Market Supervision and Management Administration (SAMR) can be officially sold in China.

    ❂ State Administration for Market Regulation (SAMR) and China Drug Administration (CDA) have decided to replace CFDA

    ❂ In IGC, since all revisions have not been finalized, they are used interchangeably with the term CFDA.


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Classification of medical devices

    Classification Definition Product
    Class I Medical devices that can guarantee safety and effectiveness through general management Basic surgical instruments
    Ophthalmology/Otolaryngology surgical instruments
    stethoscope
    Medical hammer
    Medical radiation protection equipment and supplies
    Class II Medical devices requiring additional management to ensure safety and effectiveness Medical suture
    Neurosurgery surgical instruments
    Thermometer, sphygmomanometer, spirometer
    Electrocardiogram, diagnostic device
    Disinfection and sterilization equipment
    Contraceptive
    Blood flow measuring device
    Ophthalmic optics
    Magnetotherapy machine
    Medical X-ray accessories and parts
    Ultrasound physiotherapy equipment
    Surface sealing material
    Biochemical analyzer
    ClassIII Medical devices that are used for life support or maintenance, are inserted into the human body, or have a potential risk to the human body and must be strictly managed from the viewpoint of safety and effectiveness.  Needle and electronic needle
    Electronic endoscope
    Ultrasound surgical equipment and treatment equipment
    Laser surgery and treatment equipment
    Medical high frequency equipment and equipment
    MRI, X-ray treatment diagnostic equipment
    Medical radiation therapy equipment
    Blood type analyzer
    Oxygen supply prosthesis
    Medical sealing material and bonding material
    Fluids, transfusion devices and hoses

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IGC’s Competency

    ❀ IGC is able to provide the best service in the field of certification based on long experience and trust accumulated with customers.

    ❀ As the best partner for exporting to China and other overseas certifications, IGC Certification Center accurately supports the issuance of Chinese certificates necessary for Korean companies to enter the Chinese market.

    ❀ It is possible to respond quickly to variables in the regulations of the China Sanitation Permit Bureau, which are constantly changing rapidly, and quick feedback on work is possible.

    ❀ It is possible to quickly connect to the laboratory and share the rapid progress through the Beijing branch office direct management system.




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Related Services from IGC

  • 01System certification

  • 02Product certification (Medical devices, Medicine, Food, Cosmetics)

  • 03Product test

  • 04Auditor qualification certification

  • 05Professional auditor training

Food Sanitary Registration
hinese product certification introduction

As food exports to China increase every year, customs clearance issues are becoming very important when exporting food to China.

Currently, exports of various foods such as snacks and ramen, as well as Korean health functional foods, are showing continuous growth.

As food exports to China increase every year, the issue of customs clearance to China is becoming very important. (CIQ检验检疫证明, CIQ inspection and quarantine certificate = sanitation permit)

What is an import export zone?

    In Korea, in the 1980s, only companies with certain licenses were allowed to export and import through the first class trade registration system. This was a system to secure trust in overseas customers and to efficiently manage foreign exchange.

    Currently, even if China has a business registration card equivalent to the Korean business registration card, it is only possible to import and export imports and exports only after obtaining an import-export license.

    The agency system for import and export countries is an official system recognized by the Chinese government. It is not illegal at all, and when the importer does not have an exit permit, it is a system that allows the importer to clear the import and export licensed company, and the actual taxpayer to import under the name of the accidental party.

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Exporter preparation documents

    Number

    Document name (Korean)

    Document name (Chinese)

    Document name (English)

    Issuance

    Issuing agency

    1

    제조증명서(영문)

    制作证明书(英文)

    CERTIFICATE OF MANUFACTURE

    Korea

    Ministry of Food and Drug Safety (MFDS)

    2

    자유판매증명서(영문)

    自由贩卖证明书(英文)

    CERTIFICATE OF FREE SALES

    Korea

    Ministry of Food and Drug Safety
    (MFDS)

    3

    위생증명서(영문)

    卫生证明(英文)

    HEALTH CERTIFICATE

    Korea

    Ministry of Food and Drug Safety
    (MFDS)

    4

    영문 사업자등록증

    英文营业执照

    CERTIFICATE OF BUSINESS REGISTRATION

    Korea

    National Tax Service (NTS)

    5

    공장신고증(영문)

    工厂申报证

    REGISTRATION CERTIFICATION FORM

    Korea

    Competent authority or self-production

    6

    영양성분 검사성적서

    营养成分 检测书

    PRODUCT INSPECTION CERTIFICATION

    Korea

    Manufacturing plant

    7

    제품포장지 도면

    产品包装纸 图面

    WRAPPING PAPER MAP

    Korea

    Exporter or manufacturer

    8

    품질 표시 스티커(중국어)

    食品品种标签

    LABEL STICKER

    Korea

    Exporter or manufacturer

    9

    원산지 증명서

    原产地证明

    CERTIFICATION OF ORIGIN

    Korea

    Korea Chamber of Commerce and Industry (KCCI)

    10

    인보이스

    发票

    COMMERCIAL INVOICE

    Korea

    Exporter

    11

    패킹리스트

    箱单

    PACKING LIST

    Korea

    Exporter

    12

    업체별 제품정보리스트

    货物明细

    DETAIL PACKING LIST

    Korea

    Exporter

    • In addition, several additional documents may be added depending on product characteristics.

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IGC’s Competency

    IGC is contributing to the continuous development of customers by accurately evaluating the suitability of product certifications through the technology and expertise accumulated over the years. IGC has up-to-date knowledge of a wide range of specific scopes and legal requirements in major markets around the world, and provides knowledge and services to support your entire global operations.

    Basically, when exporting to China, you need to check whether the local buyer company has an import license registered in China Customs. If there is no license, normal customs clearance will not take place.

    In this situation, IGC can contact companies from importing and exporting countries to conduct customs clearance on behalf of the importing and exporting countries, and support trade practical work necessary for export, communication with buyers, consulting, delivery, customs clearance, etc. .

    In addition, it is possible to prepare in advance exchange of the most suitable cost and prompt customs clearance method according to the characteristics of the product.


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Related Services from IGC

  • 01System certification

  • 02Product certification (Medical devices, Medicine, Food, Cosmetics)

  • 03Product test

  • 04Auditor qualification certification

  • 05Professional auditor training