Medi­cal devices inter­na­tio­nal – Chi­na and India

Regu­la­to­ry chan­ges in Chi­na and India have brought major chan­ges for manu­fac­tu­r­ers of medi­cal devices in the Asi­an mar­ket. China’s Natio­nal Medi­cal Pro­duct Admi­nis­tra­ti­on (NMPA) is now aut­ho­ri­zed to per­form inspec­tions of for­eign medi­cal devices and medi­cinal pro­ducts manu­fac­tu­r­ers. In India, manu­fac­tu­r­ers of medi­cinal pro­ducts will now be allo­wed to include elec­tro­nic ins­truc­tions for use (eIFUs) with their products.

Over­se­as inspec­tions by China’s NMPA

As of the end of 2018, inspec­tions of for­eign medi­cal devices manu­fac­tu­r­ers are among the stan­dard tasks of China’s NMPA. This is desi­gned to ensu­re com­pli­ance with Chi­ne­se qua­li­ty and safe­ty stan­dards. The inspec­tions will cover pro­ducts which are alre­a­dy on the mar­ket in Chi­na as well as tho­se which have yet to hit the market.

Manu­fac­tu­r­ers will have exten­si­ve duties to coope­ra­te with the inspec­tions, such as ensu­ring access to the rele­vant are­as and data.

Con­se­quen­ces of the inspections

Fol­lo­wing each inspec­tion, the aut­ho­ri­ty may deter­mi­ne that the rele­vant pro­duct has pas­sed inspec­tion, will pass inspec­tion after cor­rec­ti­ve mea­su­res are taken, or has fai­led to pass inspec­tion. If a qua­li­ty or safe­ty pro­blem is found, the NMPA may take far-reaching mea­su­res to miti­ga­te the­se risks, inclu­ding e.g. war­nings, (tem­po­ra­ry) import and sales pro­hi­bi­ti­ons and revo­king pro­duct import cer­ti­fi­ca­tes. Ina­de­qua­te coope­ra­ti­on on the part of the manu­fac­tu­rer may also result in the pro­duct fai­ling to pass inspection.

Use of eIFUs allo­wed in India

At the begin­ning of the year, India’s Minis­try of Health and Fami­ly Wel­fa­re added lan­guage to the Medi­cal Devices Rules 2017 under which medi­cal devices may now be dis­tri­bu­ted with elec­tro­nic ins­truc­tions for use. The new rules are desi­gned to sim­pli­fy access to infor­ma­ti­on. Moreo­ver, digi­tal infor­ma­ti­on can be com­pi­led in grea­ter detail and can be con­ti­nu­al­ly updated and multi-media con­tent can be used to make the ins­truc­tions clea­rer. Ano­ther advan­ta­ge of eIFUs is redu­cing paper con­sump­ti­on and prin­ting cos­ts. Howe­ver, the­se advan­ta­ges will only app­ly if users have the infra­struc­tu­re neces­sa­ry to use elec­tro­nic infor­ma­ti­on in a secu­re and effi­ci­ent manner.

Legal situa­ti­on in the EU

The ques­ti­on as to whe­ther ins­truc­tions for use may be pro­vi­ded elec­tro­ni­cal­ly in the Euro­pean Uni­on is not final­ly deter­mi­ned by the Direc­ti­ves curr­ent­ly in effect for medi­cal devices or by the future MDR. Ins­tead, bin­ding rules for eIFUs were estab­lished in 2012 by Regu­la­ti­on (EU) No. 207/2012 for various pro­duct cate­go­ries and user groups. This Regu­la­ti­on sets clear rules with regard to the requi­re­ments for manu­fac­tu­r­ers. For exam­p­le, a risk ana­ly­sis must be per­for­med in order to ensu­re that the level of safe­ty con­forms to the paper ver­si­on and users must be able to recei­ve a paper ver­si­on of the ins­truc­tions in a time­ly and con­ve­ni­ent man­ner upon request.


Due to the prac­ti­cal rele­van­ce of the chan­ges to the legal frame­work in Chi­na and India, manu­fac­tu­r­ers of medi­cal devices should acquaint them­sel­ves with the new regu­la­ti­ons and adapt their inter­nal struc­tures accor­din­gly. The offi­ci­al ver­si­on of the Chi­ne­se regu­la­ti­on is unfort­u­na­te­ly available only in Chi­ne­se (for now). The Indi­an Medi­cal Devices Regu­la­ti­on 2017 and the clau­ses added in 2019 are available online.


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