We are pleased to present the September 2021 issue of Asia Pacific MedTech Regulatory Intelligence

If you can't see this email click here. Dear APACMed Members,     We are delighted to bring to you the Aug-Sept issue of the 2021 Asia Pacific MedTech Regulatory Intelligence Watch steered by our Regulatory Intelligence Working Group in partnership with Cortellis.    The objective of this Watch, is to provide our members with up to date regulatory briefs and actionable insights which can contribute to key regulatory decision making processes for all markets across Asia Pacific.    Sincere thanks to the Editorial Committee and the Working Group for all their contributions.   Please feel free to reach out to us directly for any further information or questions.                         Best wishes,  APACMed Secretariat India CDSCO issued guidance document for registration of non-notified medical devices under provisions of Medical Devices Rules 2017. CDSCO issued guidance document for registration of non-notified medical devices under provisions of Medical Devices Rules 2017. Importers/manufacturers can follow this guidance for registering the products. After voluntary registration, from October 1, 2022 for Class A & B devices and from October 1, 2023 for Class C&D, respectively, devices will fall under licensing regime. On 13th Sept, CDSCO classified medical devices pertaining to Nephrology and Renal Care under provisions of Medical Devices Rules 2017. CDSCO under provisions of Medical Devices Rules 2017 has classified 44 medical devices related to Nephrology and Renal Care. Applicants now can refer to this classification for guidance while submitting registration application. Please see below link for more details. On 13th Sept, CDSCO classified medical devices pertaining to General Hospital under provisions of Medical Devices Rules 2017. CDSCO under provisions of Medical Devices Rules 2017 has classified 57 medical devices related to General Hospital. Applicants now can refer to this classification for guidance while submitting registration application. Please see below link for more details. On 13th Sept, CDSCO classified medical devices pertaining to Personal Protective Equipment under provisions of Medical Devices Rules 2017. CDSCO under provisions of Medical Devices Rules 2017 has classified 32 medical devices related to Personal Protective Equipment. Applicants now can refer to this classification for guidance while submitting registration application. Please see below link for more details. On 13th Sept, CDSCO classified medical devices pertaining to Software under provisions of Medical Devices Rules 2017. CDSCO under provisions of Medical Devices Rules 2017 has classified 60 medical devices related to Software. Applicants now can refer to this classification for guidance while submitting registration application. Please see below link for more details. On 13th Sept, CDSCO classified medical devices pertaining to Pain Management under provisions of Medical Devices Rules 2017. CDSCO under provisions of Medical Devices Rules 2017 has classified 26 medical devices related to Pain Management. Applicants now can refer to this classification for guidance while submitting registration application. Please see below link for more details. Malaysia Guideline MDA/GD/0058 - Personal Protective Equipment (PPE) - Requirements, First Edition, September 2021. This publication is intended to provide clarification on PPE that are regulated under the Medical Device Act 2012 (Act 737). All PPE Listed in Table 1 are classified as medical device if the intended use can fit the definition in Section 2 of the Act 737. An application for the registration of a medical device shall be made according to the requirements in Act 737 and in the manner determined by the Authority in Medical Device Regulations 2012. The person responsible for registering a medical device under Act 737 is the manufacturer or an authorized representative. Class A PPE registration does not require an assessment from the CAB. However, for the purpose of registration, the complete test report shall be submitted. Pakistan Online submission of Licence Applications of Medical Devices. On 26th Aug, it was notified that Drug Regulatory Authority of Pakistan has developed an online system for processing of applications of establishment licence to import or manufacture medical devices. The portal is for new applicants as well as for renewal applications of establishment licence. Sri Lanka Accepting applications manually that were carried out through e-NMRA digital platform. On 28th Aug, it was published that NMRA has started accepting application manually as online system is not working; applicants have to refile applications as per instructions issued which will impact review and approval timeline. APACMed Regulatory Intelligence Editorial Committee APACMed Regulatory Intelligence Working Group  Cerline Tsai (Abbott), Crystal Nie (JNJ), Bu Fan (Roche), Seungmi Han (Roche), Leslie Kim (Stryker), Juliana William (Baxter), Wendy Lin (JNJ), Rhoel Laderas (Baxter), Shiho Tanaka (JNJ), Sahjogita Kathuria (Terumo), Deepali Deshmukh (Baxter), Cerline Tsai (Abbott), Wendy Lin (JnJ), Sylvia Ho (BSCI), Lynn Tseng (Hologic), Sinart Gearanantranon (JnJ), Kaiye Wang (Baxter), Jaclyn Teoh (Baxter) Data powered by Cortellis Regulatory Intelligence, a suite of intelligence offerings from Clarivate. Please click here to find out more. Powered by Glue Up All-in-one CRM Software for Growing Communities