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.
China product certification introduction
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)
❁ 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.
❉ ❉ ❉
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.
❉ ❉ ❉
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.
❉ ❉ ❉
Classification of medical devices
|Class I||Medical devices that can guarantee safety and effectiveness through general management||Basic surgical instruments|
|Ophthalmology/Otolaryngology surgical instruments|
|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|
|Blood flow measuring device|
|Medical X-ray accessories and parts|
|Ultrasound physiotherapy equipment|
|Surface sealing material|
|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|
|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|
❉ ❉ ❉
❀ 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.
❉ ❉ ❉
Related Services from IGC
02Product certification (Medical devices, Medicine, Food, Cosmetics)
04Auditor qualification certification
05Professional auditor training