April 5, 2022 Regulatory Updates

Medical Devices – Asia Regulatory Updates Roundup, Mar 2022

India (CDSCO)

Classification of Medical Device pertaining to General Hospital under the provisions of Medical Devices Rules 2017

India’s Central Drugs Standard Control Organization (CDSCO) has assigned risk classifications to general hospital and orthopedic instruments such as stretchers, surgical mallets and products used with spinal cage systems. The notice, which continues a wider move to categorize medical devices based on their risks, puts risk classes for146 products into one of four categories ranging from A (lower risk) to D (higher risk). Most of the devices covered by the latest notice fall into class A or B, with a few in class C products and one (chemical cold packs for snake bites) in class D. New class C devices include electronic monitors for gravity flow infusion systems, devices that record the time and date that they are ingested by patients, and ultraviolet radiation chamber disinfection devices.

CDSCO Has posted List of Notified Bodies registered with CDSCO under MDR-2017

List of the notified bodies registered with CDSCO under provisions of medical devices rules 2017

Final GSR 174(E)_Amendment of rule 36(3) MDR to include United Kingdom under MDR,2017

India adds the UK to list of territories that offer a shortcut to import licenses
The Indian government has added the UK to the list of countries that offer importers of medical devices a fast track to the granting of an import license. India previously covered the UK as part of the EU. The change affects the section of the Medical Device Rules, 2017 that deals with the granting of licenses to import products into India. Typically, India grants import licenses after examining documents filed through an online portal and reviewing the inspection report. However, importers with certificates of free sale from certain jurisdictions can obtain licenses without undergoing clinical investigation.

India seeks feedback on draft medical devices policy

India’s Department of Pharmaceuticals (DoP) has released a draft national medical devices policy for consultation. The policy is part of a push to “help the sector realize its full potential by creating a robust regulatory framework with feedback mechanisms.”
Quality standards and safety of the devices” sits alongside regulatory streamlining” on the list of areas of focus identified in the draft. The draft addresses the focus on quality standards, the goal of which is to “provide safe devices to the consumers, in harmony with the global standards,” in a section on DoP’s plans for regulatory streamlining.


S.R.O. 430(I)/2022 Notification of Amendments in Form 6A and Form 7A of the Medical Devices Rules, 2017

DRAP has amended Form 6a Application form for enlistment or renewal of class a medical device or accessory or component for import and Form 7a Application form for registration or renewal of class b, c & d medical device or accessory or component for import


Draft: Abridged Processing of Application for Registration/Notification of Medical Devices Approved by the National Regulatory Authority of any ASEAN Member Country

The Philippine Food and Drug Administration (FDA) is seeking feedback on the expedited review of medical devices that already have been authorized by another national regulatory authority (NRA) in the Association of Southeast Asian Nations (ASEAN).
In line with World Health Organization advice about the benefits of relying on other regulatory agencies, FDA has set out draft guidelines on the abridged processing of fillings for registration and notification of certain medical devices. The expedited pathway will apply to products approved by the NRA of an ASEAN member country under the requirements of the ASEAN Medical Device Directive Common Submission Dossier Template (AMDD-CSDT).

Addendum to FDA Circular No. 2021-002 Re: Full Implementation of Administrative Order No. 2018-0002 entitled “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements

This issuance shall cover Class B, C and D medical devices that are not included in the list of registrable medical devices based on FC No. 2020-001-A entitled “Amendment to Annex A of FDA Circular No. 2020-001 re: Initial Implementation of Administrative Order No. 2018-0002 “Guidelines Governing the Issuance of an Authorization for a Medical Device Based on the ASEAN Harmonized Technical Requirements


Circular of the State FDA on Matters Concerning the Implementation of the “Quality Management Practice for Clinical Trials of Medical Devices” (No. 21 of 2022)

The “Quality Management Practice for Clinical Trials of Medical Devices” (2022 No. 28) (hereinafter referred to as the “Code”) has been released and will be implemented from May 1, 2022. In order to do a good job in the implementation of the “Specifications”, the relevant matters are hereby announced

Announcement of the National Health Commission of the State FDA on Issuing the “Quality Management Practice for Clinical Trials of Medical Devices” (2022 No. 28)

In order to deepen the reform of the review and approval system for medical devices and strengthen the management of clinical trials of medical devices, in accordance with the Regulations on the Supervision and Administration of Medical Devices (Order No. ), the “Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents” (Order No. 48 of the State Administration for Market Regulation), the State Drug Administration, together with the National Health Commission, organized the revision of the “Quality Management Practice for Clinical Trials of Medical Devices”, which are hereby promulgated. Effective May 1, 2022

The State FDA issued three normative documents including “Guidelines for Compiling Annual Self-Inspection Reports for Medical Device Quality Management System”

In order to strengthen the supervision of medical device production and ensure the safety and effectiveness of medical devices, in accordance with the relevant provisions of the “Regulations on the Supervision and Administration of Medical Devices” and “Measures for the Supervision and Administration of Medical Device Production”, the State Food and Drug Administration has recently revised and issued the “Annual Self-inspection of the Medical Device Quality Management System”. Report Compilation Guidelines” and “Catalogue of Prohibited Entrusted Production of Medical Devices”, and formulated and issued “Guidelines for the Compilation of Quality Agreements for Entrusted Production of Medical Devices”. The above three normative documents will be implemented from May 1, 2022.

The State FDA issued a notice on the implementation of relevant matters in the “Measures for the Supervision and Administration of Medical Device Production and Medical Device Operation”

The notice has five main contents: First, it requires regulatory authorities and production and operation enterprises to implement their territorial supervision responsibilities and the main responsibility for quality and safety, and strengthen the publicity and training of the “Production Measures” and “Operation Measures”; The filing is handled in accordance with the time limit and requirements of the new measures, embodying the spirit of “delegating power, regulating and serving”, and providing convenience for enterprises; the third is to clarify the format and printing requirements of licenses and filing certificates, and the filing department can provide first-class medical devices according to the needs of enterprises. Production record certificate, Class II medical device business record certificate; Fourth, clarify the change, renewal and reissuance of license record within the validity period, as well as whether the content of the validity period and number of the certificate has changed; Fifth, require drug supervision and management at all levels The department strengthens the application of information management of license filing, actively promotes the issuance and application of electronic licenses for medical device production and operation licenses, and continuously optimizes the query and sharing of production and business license filing information and data.


Administrative notice of partial revision of regulations on safety information management such as side effects of medical devices

In order to inform the public in advance of the partial revision of Regulations on Safety Information Management such as Side Effects of Medical Devices (Ministry of Food and Drug Safety Notice No. 2020-87, 2020.9.14), the purpose , reason for the revision , and main contents is announced as follows in accordance with Article 46 of the Administrative Procedure Act .
This is to introduce an internationally harmonized standard code for medical device adverse events to improve the speed of reporting, analysis, and evaluation of medical device adverse events and to promote information exchange with overseas adverse events.


Guidance on Requirements for Import / Re-export Medical Imaging Materials

SFDA has published guidance document MDS-REQ 4 on Requirements for the Import and Clearance of Medical Imaging Materials and Particle Accelerators Used in Radioisotopes Formation for Medical Applications
The purpose of this document is to specify and clarify the requirements for importation and clearance of medical imaging materials and particle accelerators used in radioisotopes formation for medical applications


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