의료기기 이야기

The New Zealand (NZ) Associate Minister of Health announced the intent to repeal the Therapeutic Products Act 2023 (TPA), which otherwise would come into force this year, with most provisions taking effect on September 1, 2026. On May 23, the Associate Minister also released a lightly redacted Cabinet paper and decision meeting minutes outlining the rationale behind the Ministry decision. Develo..

한국의료기기협동조합에서 인도네시아 의료기기 중 이슈사항 변경내용을 발표하였다. ▶ 주요내용모든 의료기기 수입 및 유통업자 CDAKB 인증필수- CDAKB: Cara Disribusi Alat Kesehatan Yang Baik- 국내 제조업체는 새로운 요구사항이 인도네시아 시장 진입에 영향을 미치지 않도록 현지 판매 파트너사 (대리점)의 CDAKB 인증서 보유 확인이 필요한 내용 임- 2024년 07월 01일 부터 모든 신규 의료기기 허가 신청 (AKL)시 CDAKB 인증 필수- 기존 IDAK (의료기기 유통 허가) 라이센스 소지자는 갱신 시 GDPMD 인증 필요  인도네시아 의료기기 시장 이슈 리포트(2024년 상반기) – 한국의료기기협동조합 (medinet.or.kr) 인도네시아 의료기기 시장 이슈 ..

The regulator in Mexico, COFEPRIS, released a 5.0 edition of the Supplement of Medical Devices of the Mexican Pharmacopoeia (hereafter: Pharmacopoeia), which inserted regulatory requirements for Software as a Medical Device (SaMD). Software was included officially in the definition of medical devices and rule 16 was added to Appendix II to classify software according to risk (Class I, II, or III..

Brazilian medical device regulator ANVISA has published new legislation allowing manufacturers of higher-risk devices to leverage registrations from some foreign regulatory authorities when applying for market access in Brazil. According to the new Reliance route which started June 3, ANVISA will now rely on the decisions of authorities from other jurisdictions, but remains independent and respo..

A recent round of inspections by the Dutch Health and Youth Inspectorate (IGJ) has found that more than one-third of European Authorized Representatives (ARs) operating in the Netherlands have yet to meet all requirements applicable under the European Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). European Authorized Representatives under supervisionE..

This week the UK medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the launch of a four-week public consultation seeking the views of various stakeholders to improve safety measures for high-risk IVDs by including Common Specification (CS) requirements in the UK legislation (Medical Devices Regulations 2002 (MDR 2002)). In addition, they also seek..

This is the first in our series on the UK MHRA initial draft recognition policy to leverage international regulatory authorizations for access to the medical device market. The UK medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) hosted a webinar in March on the update of the draft medical devices scope, classification and essential requirements. This was a..

On April 15, 2024, the Medical Device Coordination Group (MDCG) released a new guidance document; MDCG 2024-4 Safety Reporting in Clinical Performance Studies of in Vitro Diagnostic (IVD) under the EU IVD Regulation (2017/746, IVDR). The guidance provides an in-depth look at safety reporting requirements for IVD performance studies under the IVDR. It introduces a tabular performance study Summar..

In recent years, the FDA has embarked on an ongoing journey to develop a premarket review approach for artificial intelligence (AI)/machine learning (ML) software modifications. This journey included the Agency’s 2019 discussion paper and request for feedback on the proposed regulatory framework, several workshops to gather inputs from various stakeholders, as well as the Agency’s action plan re..

We at Emergo by UL are proud to have had one of our senior consultants attend the MedCon Conference in Columbus, Ohio on April 24-26. Here we describe some of our top pre-market consideration takeaways from the conference for those who were unable to make it. We encourage all regulatory professionals to consider attending next year! But if you can’t, no worries. We will report all the medical de..