By Stewart Eisenhart, Emergo Group
Pakistan’s Drugs Regulatory Authority has issued new medical device and in vitrodiagnostic (IVD) regulatory requirements, the Medical Devices Rules, 2015, that have gone into effect.
The new regulations include requirements for conformity assessments, quality management systems, classification guidelines, authorized representation for foreign manufacturers and related registration steps. Publication of the new rules follows legislation established in late 2012 to formally regulate medical devices and pharmaceuticals in Pakistan.
Upon initial analysis, the regulations appear based partially on guidelines from the International Medical Device Regulators Forum (IMDRF) and its predecessor organization, the Global Harmonization Task Force (GHTF), as well as the European Medical Device Directives. However, Pakistani officials have also borrowed elements such as Common Submission Dossier Templates (CSDT) from the Association of Southeastern Asian Nations (ASEAN) regulatory harmonization framework; these incorporations suggest that Pakistani regulators seek to attract manufacturers from markets such as the US, Europe and Canada that are familiar with IMDRF principles as well as firms from developing Asian markets such as Singapore and Malaysia.
Pakistan’s conformity assessment requirements
Medical device registration in Pakistan now entails conformity assessments of registrants’ quality management systems, post-market surveillance systems and technical documentation; declarations of conformity must also be provided.
Quality system conformity assessment requirements depend upon the type of registrant seeking commercialization in Pakistan. Manufacturers must show compliance with ISO 13485 quality system requirements, while importers, authorized representatives and distributors must comply with Good Distribution Practices for Medical Devices (GDPMD).
The Pakistani government has established a Medical Device Board (MDB) that oversees registration of both medical devices and of Conformity Assessment Bodies authorized to conduct conformity assessments of companies authorized to market their devices in the country.
Classification of medical devices and IVDs
The Pakistani Drugs Regulatory Authority has established a four-tier classification system for medical and IVD devices: Class A (lowest risk), Class B, Class C and Class D (highest risk). Regulators have developed distinct classification criteria for medical devices and IVDs based on risk characteristics.
The new regulation also provides guidelines for device classification and grouping based on various characteristics, including non-invasive, invasive, active and short- versus long-term implantable uses.
New, but not unfamiliar
Interested parties should refer to the published regulation (link at the beginning of this post) issued by the Drugs Regulatory Authority for full details of Pakistan’s new registration pathways for medical and IVD devices. Although Pakistani authorities have installed a new medical device regulatory system, it should not be unfamiliar to manufacturers with previous registration experience in other markets.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
