A Circular has been published1 that outlines the policy for the implementation and enforcement under the Medical Device Act 2012 (Act 737) of the recognition and listing of institutes or laboratories that are capable of carrying out and providing data…
Minor revisions1 have been made to Appendix 1 of the Circular Letter of the Medical Device Authority No 2 Year 2014, Conformity Assessment Procedures for Medical Device Approved by Recognised Countries. In Table 1 (Recognised foreign regulatory authorities and notified…
Three consultations on regulatory changes that could affect the medical device industry were held in Australia in the final quarter of 2016: Regulatory framework for advertising therapeutic goods1. Comments were solicited on the appropriate body or bodies for the handling…
Enforcement of the new, stricter conformity assessment procedures for medical electrical equipment in Brazil has been delayed again, this time until 30 April 20171. These new conformity assessment requirements are contained in Ordinance No 54 of 1 February 2016, which…
Swissmedic, the Swiss Agency for Therapeutic Products, has decided to follow the harmonised European approach for handling CE mark certifications of manufacturers affected by the de-designation of their Notified Bodies1. Like its counterpart in France, Swissmedic has established a period…
In anticipation of the implementation of the new European Regulations on medical devices and in vitro diagnostics, Sweden has proposed to transfer responsibility for Notified Bodies from the Swedish Board for Accreditation and Conformity Assessment (SWEDAC) to the Medical Products…
The French National Agency for the Safety of Medicines and Health Products (ANSM) has issued steps1,2 for medical device manufacturers to follow if their Notified Bodies cease operations, either voluntarily or following a de-notification decision. Currently, there is no European…
On 16 February 2017, the Court of Justice of the European Union delivered its judgment1 on the case concerning breast implants manufactured by Poly Implant Prothèse (PIP) using inferior quality industrial silicone. The Court found that, under Directive 93/42/EEC, a…
All imported medical devices, food supplements, medical cosmetics, herbal products and other allied healthcare borderline products that are controlled by the Pharmacy and Poisons Board (PPB) must comply with the Pre-Export Verification of Conformity (PVoC) to Standards programme implemented by…
Manufacturers have been provided with guidance on determining when a change to a marketed product constitutes a ‘substantial change’ and therefore requires prior notification to, and assessment by, the Therapeutic Goods Administration under the conformity assessment procedures1. The guidance also…
Interested parties had until 30 June 2017 to comment on a proposal from the Therapeutic Goods Administration (TGA) concerning the use of marketing approvals from comparable overseas regulators to support inclusion of devices in the Australian Register of Therapeutic Goods…
The Medical Device Authority has officially recognised1 the Institute for Medical Research (IMR) as one of the institutions or laboratories capable of conducting, and reporting on, clinical evidence or performance evaluation for conformity assessment by a Conformity Assessment Body (CAB)…
The European Commission has published a draft Implementing Regulation1 on the list of codes and corresponding types of devices for the purposes of specifying the scope of the designation as Notified Bodies in the field of medical devices under Regulation…
What is MDSAP? The regulatory environment of the medical device industry is constantly evolving which means it is not always clear which changes must be responded to. Among these changes is the Medical Device Single Audit Program (MDSAP), which impacts…
Normative Instruction (IN) No 22 of 20 October 20171 approved updates to Annexes I and II to IN No 4 of 24 September 2015. Annex I to IN No 4/2015 contains a list of technical standards to be adopted in the certification…
Commission Implementing Regulation (EU) 2017/2185, which was published in November 20171, lists the codes and corresponding types of devices for the purpose of specifying the scope of the designation as Notified Bodies under Regulation (EU) 2017/745 on medical devices and…
On 21 February 2018, the fees chargeable by registered Notified Bodies for auditing manufacturing sites in accordance with the Medical Devices Rules, 2017 were published by the Drugs Controller General (India)1. These fees have been approved by the Ministry of…
Updates to chapter 4 (on medical devices) of Annex 1 to the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment have been published in the Official Journal of the European Union1.…
