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.back