CHINA Law and Practice Contributed by: Alan Zhou, Coco Fan, Kelly Cao, Stephanie Wang and Rae Zhang, Global Law Office
Prior Authorisations for Importation of Medical Devices The following applies: • imported medical devices must first be filed/regis- tered with the NMPA and obtain marketing authori- sations; • if the imported medical devices fall within the Catalogue of Products Subject to the Compulsory Product Certification System, a Chinese compul- sory certification is required; and • if the imported medical devices fall within the Cata- logue of Commodities Subject to the Automatic Import Licence Administration, an automatic import licence is required. Medical institutions may import a small quantity of pharmaceuticals or medical devices for urgent clinical needs subject to approval by the NMPA or the Pro- vincial People’s Government authorised by the State Council, and to the following restrictions. • The pharmaceuticals for urgent clinical needs should have already been approved and marketed overseas, but not in China, are not produced by any enterprise, or cannot be resumed for produc- tion within a short period of time. If the pharma- ceuticals fall within the scope of narcotic drugs or psychotropic drugs, an additional import permit issued by the NMPA is required. • The medical devices for urgent clinical needs must be Class II or Class III medical devices that are already approved and marketed overseas but have no equivalent product of the same type in China, and must not include medical devices subject to configuration permit management for large-scale medical devices. To meet peoples’ needs for pharmaceuticals and medical devices, more and more policies have been issued by local governments to optimise import approval procedures for designated medical institu- tions to apply for drugs and medical devices in urgent clinical needs, such as nine cities in the Guangdong Province-Hong Kong-Macao Greater Bay Area, Bei- jing, Shanghai and Hainan Boao Lecheng International Medical Tourism Pilot Zone. A tax exemption is also applicable in Hainan.
SAMR (eg, departments responsible for anti-monop- oly, anti-unfair competition, and advertising supervi- sion) jointly govern the operation, distribution and use of pharmaceuticals and medical devices. 7.2 Importer of Record of Pharmaceuticals and Medical Devices The consignee can either entrust a customs broker as the importer of record or act as the importer of record itself. If the importer of record concurrently acts as the appli- cant for the NMPA’s import filing (eg, import permit for narcotic drugs and psychotropic drugs or special approval in exceptional cases as noted in 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices ) and port inspection for import- ed pharmaceuticals, it must maintain a drug distribu- tion licence or a drug manufacturing licence (for active pharmaceutical ingredients and intermediate agents). 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices Prior Authorisations for Importation of Pharmaceuticals The following require prior authorisation. • In general, imported pharmaceuticals must obtain marketing authorisations from the NMPA prior to importation. An additional import permit issued by the NMPA is required for narcotic drugs and psy- chotropic drugs. • In exceptional cases, pharmaceuticals can be imported by means of a special approval from the NMPA: (a) a small number of drugs to be imported by a hospital and used for specific medical purpos- es due to urgent clinical needs; and (b) drug samples and comparator drugs needed for research and development or testing for drug registration purposes. Small quantities of pharmaceuticals within a reason- able range carried by individuals to China for personal use are exempted from these requirements.
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