Dear APACMed Members, We are delighted to bring to you the December 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 |
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NMPA Letter: Explanatory Note of Fourteenth Five-Year Plan on National Drug Safety and Promotion of High Quality Development,30-Dec-2021. The document summarizes the country's plan for drugs, medical devices and cosmetics, from 2021 to 2025 and its vision for 2035. CMDE Announcement No.2021/16: Matters Related to Medical Device Registration Application Payment Fee, 01-Dec-2021. After the application for registration of medical devices and in-vitro diagnostic reagents is accepted, if the applicant is required to pay fees, the applicant shall pay the fees as required. If the applicant fails to pay the fees within 15 working days, it shall be deemed that the applicant has withdrawn the application voluntarily, and the NMPA shall terminate its registration procedures. In order to fully implement the requirements of the regulation, the relevant matters concerning the payment of fees for medical device registration applications are hereby announced (read here). This document includes: 1. Applicable scope: Applicable to domestic Class III and imported Class II and Class III medical device registration, change registration, renewal of registration, and approval of clinical trials of Class III high-risk medical devices. 2. Registration fee standards: Follow the CFDA Announcement No. 2015/53: Issuance of the Charging Standards for Registration of Pharmaceutical Products and Medical Devices, 27-May-2015. 3. Payment requirements 4. Appendix: List of medical device registration application items that have been accepted before December 1, 2021 but have not yet paid the registration fee. NMPA Announcement No.2021/157: Issuance of Review and Approval Procedures for Medical Devices in Case of Emergencies, 29-Dec-2021.Although there are not many approved products for emergency approvals, enterprises can know this kind of special procedure. NMPA Announcement No 2021/158: Announcement of the NMPA on Issuing the catalogue of class I medical devices, issued on 30 Dec, 2021. In order to implement the requirements of the regulations on the supervision and administration of medical devices (Order No. 739 of the State Council) and further guide the filing of class I medical devices, the State Drug Administration has organized the revision of the catalogue of class I medical devices, which is hereby promulgated. The catalogue shall come into force as of January 1, 2022 (read announcement). |
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G.S.R. 918(E) - MDR Amendment - The ministry of health and family welfare has decided to extend the date of implementation of the unique device identification (UDI) of medical devices, which was to come into effect from January 1, 2022, till further orders. Under the Rule 46 of the Medical Devices Rules, the Centre has earlier decided that “With effect from 1st day of January, 2022, a medical device, approved for manufacture for sale or distribution or import, shall bear unique device identification which shall contain device identifier and production identifier.” For the purpose of the rule, device identifier means a global trade item number and production identifier means a serial number, lot or batch number, software as a medical device version, manufacturing and expiration date. In the proposed amendment, the government decided not to fix any date of implementation of the UDI and also skipped the implementation of production identifier. In a draft amendment, notified by the Ministry on December 23, this rule is proposed to amend as “With effect from the date as may be specified by Central government, a medical device, approved for manufacture for sale or distribution or import, shall bear unique device identification in the manner as may be determined.” |
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Requirements for Labelling of Medical Devices , MDA/GD/0026, 4th Edition, Oct 2021. Additional labeling requirement on medical devices has been outlined in this latest guidance document. It also includes further details on the labeling FAQ which was published recently. Conformity Assessment Procedures for Medical Device Approved by Recognized Countries. MDA has now added EU MDR and EU ICD as additional approval type issued by notified body. It has also accepted MHRA as one of its recognised foreign regulatory authority (circular). |
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Draft for Comments: Rules and Regulations Governing the Issuance of an Authorization for IVD. FDA CDRRHR requests input to the latest draft version of the rules and regulations governing the issuance of an authorization for IVD. Summary below: - The applicant shall apply for CIVDN (Class A) or CIVDR (Class B, C, D) based on the classification of IVD (based on Annex 3 of the AMDD).
- Approval of application for CIVDR shall be based on compliance with the FDA legal and technical requirements and results of performance evaluation by NRLs
- Reagents, reagent product, calibrator, control material, kit, instruments, apparatus, equipment or systems or software manufactured, sold or represented by manufacturers not for use in in-vitro diagnostic application and general laboratory use purposes are not classified as IVD
- IVD strictly for research, clinical trial, exhibit and/or donated brand new IVD equipment except for the reagents are exempted from notification and registration. However, the researcher, institution and/or user of such devices shall apply for a CIVDL.
- All IVDs shall follow the existing labelling requirements of medical devices.
PHASES OF IMPLEMENTATION: - Phase 1 (6 months after the effectivity of this order): Registration of IVDs based on the latest FDA list of registrable IVDs, Notification of all Class A IVDs, notification of Class B, C and D IVDs that are not included in the latest FDA list of registrable IVDs, and IVD listing.
- Class A – 5 years and shall be renewed every 5 years after initial approval.
- Class B, C and D IVDs – 2 years after which the MAH shall apply for registration.
- Phase 2 (schedule shall be issued in separate FDA Circular): Registration of all Class B, C and D IVDs (Notification of Class B, C and D shall cease during this phase)
- NRL shall inform and update FDA regarding its capability to conduct performance evaluation of IVD.
- FDA shall issue updated list of IVDs that need to undergo performance testing of NRLs prior to registration.
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Guideline: Guide-0101-02: Sterile Medical Device Packaging Quality Control Guidelines, Dec-2021. This guideline aims to help medical device manufacturers to apply Medical Device Manufacturing and Quality Control Standards to medical device packaging to which the sterilization process is applied after packaging with a sterilization protection system, it provides major considerations when designing and developing packaging and performing process validation. Guideline: Guide-1182-01: Guideline for Approval and Review of Catheter for Balloon Dilation Angioplasty, 22-Dec-202. For catheters for balloon dilation angioplasty, relevant international standards (ISO 10555-1,10555-4) were revised in 2017 and 2013, respectively, and domestic application of the latest internationally harmonized evaluation method is required (link). MFDS Guideline: Guide-1184-01: Guidelines for Handling of Medical Devices Subject to Tracking Management, 22-Dec-2021. The purpose of this guideline is to provide information on management of distribution and usage records of medical devices subject to tracking management, including management standards, methods of preparation, preservation and submission of records, etc., manufacturers, importers, sales, leasing companies, and medical institutions. |
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New Advertising Promotion Licensing Regulation - Advertising Promotion and Licensing Regulation is being updated to include digital in the scope, such as the use of internet and social media. Advertising/ Promotion directed to HCP only requires notification to TH FDA while Advertising/ Promotion to public requires advertising and promotion license from TH FDA. It also gives details on what is allowed or not allowed when creating Advertising/ Promotion material in Thailand. |
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Labeling Regulation Update - Decree 111.2021/NĐ-CP to supplement and adjust for Decree 43.2017/NĐ-CP. New Decree 111.2021/NĐ-CP to supplement and amend Decree 43.2017/NĐ-CP is effective from 15th February 2021. Highlighted point: origin label must have information of "Origin of the goods". |
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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), Jaclyn Teoh (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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