What can we do for you?
Our certificate services
In the area of certifications for China, Cisema can offer you practical support in numerous areas.
- Among other things, in determining whether a certification is relevant for your products.
- In case a certification, registration or licenses, are necessary for you, we will accompany you throughout the entire process. From the application until a certificate is issued.
- If changes, extensions for obtained certifications, or a renewal of the validity should become necessary, we shall gladly handle that for you.
- For one-time deliveries to China, or if the product is used for a special purpose – for example in connection with small import quantities – a certification may not be necessary at all and exceptions (waiver) can be applied for. This procedure is part of our portfolio and we are absolutely familiar with it.
National Medical Products Administration
NMPA approval
NMPA approvals (NMPA stands for National Medical Products Administration, formerly CFDA – China Food and Drug Administration) are important for the import of medicines, food, medical devices (including IVDs) and cosmetic products in the P.R. China.
Pressure Equipment Directive in China
SELO pressure vessel license
China has its own regulations and standards for the safety of pressure vessels and pressurized parts. Usually the following devices fall under this directive: stationary and mobile pressure vessels, boilers, kettles, heat exchangers, valves, bursting discs and, to a certain extent, also pipes and tubes. Parts already installed in a plant may also be subject to this obligation.
Proof of compliance regarding energy efficiency criteria
Energy Label Marking for China
For certain products, such as electric motors or household appliances, a marking with the China Energy Label (CEL) is mandatory. The system is similar to a manufacturer’s declaration and resembles the European system in which consumers can find out the energy consumption of electrical appliances at a glance.
China Compulsory Certification
CCC Certification
- Certification: NMPA, CCC, pressure vessels, Energy Label
- Sourcing and quality assurance
- Logistics and customs support
- Sales support
For components of nuclear facilities
HAF 604 Certification
The Chinese HAF 604 certification is mandatory and proves the safety of certain components in nuclear facilities, as well as in other fields of civil use of nuclear technology.
Non-applicability and exemption confirmations
Other certificates and confirmations
Besides our main activities in the area of certification for China, Cisema can also offer you the ideal range of services in other sectors. This applies especially to clearance confirmations and exemption certificates (waivers) concerning the CCC certification, which serve as a proof for the Chinese Customs.
Hong Kong Medical Device Administrative Control System
MDACS Listing
The Hong Kong SAR government launched the Medical Device Administrative Control System (MDACS) to promote the safety and effective use of medical devices (including IVDs), as well as to ensure the prerequisites are met by the importers or traders. The MDACS features a system for manufacturers and importers to list their products and report adverse incidents.
