Dear APACMed Members, We hope you are doing well during these challenging times. We are delighted to bring you the June 2021 issue of the Asia Pacific MedTech Regulatory Intelligence Watch. The objective of the Watch, brought to you by our Regulatory Intelligence Working Group, in partnership with Cortellis, is to provide APACMed members with timely regulatory updates and actionable insights for markets across Asia Pacific. Sincere thanks to the Editorial Committee and Working Group for their contributions to this newsletter. Please feel free to reach out to us directly for any further information or questions. Best wishes, APACMed Secretariat |
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On 8th June, Administrative Order 2021-0036: Guidelines on Compliance with Section 35 (b) of Republic Act No. 11223 (Universal Health Care Act) by All Drug, Medical Device, Biological and Medical Supplies Manufacturers to Submit Reports on Disclosure of Financial Relationships with Health Care Providers and Health Care Professionals was signed. This Order shall apply to all FDA-licensed manufacturers, traders, repackers and distributor-importers and distributor-wholesalers of drug, medical device and biological products, including vaccines, and medical supplies registered with the FDA. It was signed June 8 and enforceable 15 days after publication. It requires the companies who have “financial relationships” with HCPs to upload ""Disclosure Reports"" on these relationships twice a year (first disclosure report starts on July 15, 2021 and January 15, 2022). The website for uploading reports: https://odrs.fda.gov.ph/login A Draft Administrative Order: Framework for the Philippine Essential Medical Devices List and Price Reference Index was issued.This Order aims to set the national framework for developing the Philippine Essential Medical Device List (PEMDL) and Price Reference Index for Medical Devices and supplies in the DOH. Proposed actions: provide APACMED input to joint position paper planned by PAMDRAP, HTAP Offices/Bureaus, Centres for Development (CHDs) and all healthcare facilities under the DOH procuring and/or utilizing medical devices, supplies and equipment herein referred to as End-User. The following are its specific objectives: - To establish a system and methods for creating and maintaining a database of essential medical devices;
- To set the price reference index for medical device as the recommended prices for all DOH health facilities; and
- To provide guidelines on the enforcement, implementation, and monitoring of the price reference index system across DOH End-User Units
AMDD issued a Draft FDA Circular: Adoption of the Post Marketing Alert System (PMAS) Requirements, Annex 5 of the ASEAN Medical Device Directive (AMDD). Philippine is adopting the Post Marketing Alert System requirements of the AMDD. Specific guidelines to be published. There will be a 1-year transition period where reporting will be voluntary. After the AO has been effective, reporting will be mandatory. The requirements apply to ALL medical devices, including IVDS, REGARDLESS if they are registrable or not. Proposed actions: PAMDRAP to submit position paper/clarificatory questions. Members encouraged to provide feedback before public hearing on June 25, 2021 |
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On 27th May, Prime Minister Ordinance No. 1700: Regulation on Support and Management of Innovative Medical Devices was released. The purpose of this Ordinance is to support Law No. 16405: Medical Devices Industry Development and Innovative Medical Devices Support Act (Medical Devices Industry Act), 30-Apr-2019 (IDRAC 294090) in strengthening the competitiveness of the medical device industry and promoting the commercialization of innovative medical devices. This Ordinance regulates the support and management of innovative medical devices, etc., procedures, methods, etc. for step-by-step review and priority review of devices are established; standards and procedures for certification of innovative medical device software manufacturers are established and procedures for permitting and reporting changes to innovative medical device software are reported. Methods specifying clinical trial management standards for innovative medical device software are prescribed and procedures and methods necessary for supporting clinical trials for innovative medical device software or standardizing innovative medical device technology are prepared. This regulation covers such topics, as: 1. Procedure and method of step-by-step review of innovative medical devices (Art. 3) 2. Scope and procedure of expedited examination for innovative medical devices (Art. 4) 3. Procedures and methods for establishing audit criteria for innovative medical devices (Art. 5) 4. Procedures and methods of post marketing investigation on innovative medical devices (Art. 6) 5. Certification standards, certification procedures and certification cancellation procedures, etc. of innovative medical device software manufacturing companies (Art. 7 to 9) 6. Procedures and methods for permission to change the innovative medical device software (Art. 11 to 13) 7. Specification of clinical trial management standards for innovative medical device software (Art. 14) 8. Policy support for innovative medical devices (Art. 16 to 18) The revision concerns: 1. Improvement of the procedure for reviewing each stage for innovative medical devices, etc. (Art. 3) Simplified procedures such as deleting unnecessary attached documents when applying for a step-by-step review to improve the efficiency of handling civil complaints are proposed. 2. Application for designation of professional manpower training institutions, etc. (Art. 18-2) Preparation of the application form and designation form for the designation of professional manpower training institution 3. Review-by-stage fee adjustments (Attached Table 2) This is a final version of a draft document MFDS Document for Public Comment: MFDS Announcement No. 2020-583: Legislative Advance Notice on Partial Amendment of Regulation on Support and Management of Innovative Medical Devices (Draft), 30-Dec-2020 (IDRAC 323525). This document replaces Prime Minister Ordinance No. 1617: Regulation on Support and Management of Innovative Medical Devices, 29-May-2020 (IDRAC 312856). On 27th May, MFDS issued MFDS Notification No. 2021-43: Establishment of Provision on Renewal of Medical Device Manufacturing License, Etc. This document provides information on renewal procedures for medical devices. It covers: - Matters concerning the standards for renewal of manufacturing license, etc. (Art. 3)
- Matters concerning the procedures for application for renewal and how to prepare an application (Art. 4 and 5)
- Matters concerning the types, scope of exemption and requirements for renewal submission data (Arti.6 to 8) 4. Matters concerning the supplementation of data, renewal processing, and designation of expiration date of license (Art. 9-12) This document replaces a draft version: MFDS Document for Public Comment: MFDS Announcement No. 2021-112: Administrative Advance Notice on Establishment of Provision on Renewal of Medical Device Manufacturing License, Etc. (Draft), 12-Mar-2021 (IDRAC 326942). Background: Previously Korea product license didn’t have expiry date. However, based on the newly established Article 49 of the Medical Devices Act, 5yrs of expiry has been granted to newly cleared product licenses as of Oct 2020. For the existing registrations, the expiry date will be separately granted by MFDS as per the original approval date.
- Detailed Requirements for License renewal
- Original copy of product license
- Data in each of the following items clarifying that the safety and effectiveness of the medical device is maintained during the previous expiration date
- Documents reviewed to reflect the latest standards set by the MFDS or equivalent international standards (IEC, ISO, etc.)
- Documents that can confirm the performance and safety
- Biocompatibility test or IEC test reports per the latest standard, Or;
- Evaluation data issued by the 3rd party of testing and inspection institution designated by the Minister of Food and Drug Safety, Or;
- Evaluation data issued by an international testing institution accredited by ISO/IEC17025 according to the Mutual Recognition Agreement (MRA) of the International Laboratory Accreditation Cooperation (ILAC) which can test all test items corresponding to the renewal medical device international standards
- History record of the production or importation of the medical device during the previous expiration date
- Safety information and action data collected during the previous expiration date
- Post market safety and effectiveness data, Or:
- Customer complaint handling records (limited to cases where there is an adverse event result) and action data
- For foreign data, the Korean summary (excerpt of the main contents) and the original text should be submitted, and if necessary, the full translation should be submitted. However, data in foreign languages other than English must be accompanied by a notarized full translation.
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On June 15th, NMRAannounced Renewal of expired import licences with valid registration certificates of medicines. The NMRA has decided to accept the applications (following the guidelines published on the NMRA website on June 15,2021) until 4.00 p.m. July 05, 2021. As such we can submit requests (by email: mediext.nmra@gmail.com) to extend import licences that expired on or before June 30, 2021 but have a valid registration certificate. Normal procedure to be followed for obtaining/extending import licences which do not fall under this category. However, as per condition mentioned in notice dated Jun 15,2021 this extension is not applicable for registration certificates which have been extended due to pandemic situation, hence purpose of importing a product on an extended license will be defeated, hence this should be reconsidered by the authorities. |
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Required information - importation - License No.
- Medical device name
- Name and Country of Manufacturer
- Quantity/Volume imported
- Importation
Required information – Sales - License No.
- Medical device name
- Manufacturer name and production source
- Buyer's name
- Quantity/Volume of Sales
- Sales value
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APACMed Regulatory Intelligence Editorial Committee |
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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)
Data powered by Cortellis Regulatory Intelligence, a suite of intelligence offerings from Clarivate. Please click here to find out more. |
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