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

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Dear APACMed Members,  
 
We hope you are doing well during these challenging times. 
 
We are delighted to bring you the August 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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China
On 18th August NMPA called for comments for updating class I exemption list. Opportunity for industry to declassify for certain medical devices.


On 20th August, NPC (National People's Congress) published Personal Information Protection Law of the People's Republic of China. Members need to review this and make sure they ensure compliance with this new law.

On 31st August, SAMR released Order 48 on Administrative Measures for In-vitro Diagnostic Reagents Registration and Filing. State Administration for Marketing Regulation officially(SAMR) released “Administrative Measures for In-vitro Diagnostic Reagents Registration and Filing (Order 48, SAMR)” and the policy will come into force on October 1st , 2021.

On 31st August , SAMR released Order 47 on Administrative Measures Medical Devices Registration and Filing. State Administration for Marketing Regulation officially(SAMR) released “Administrative Measures for Medical Devices Registration and Filing (Order 47, SAMR)” and the policy will come into force on October 1st , 2021, and the original “Administrative Measures for Medical Devices Registration (Order 4) will be repealed at the same time.
India
On 6th August, CDSCO classified medical devices pertaining to Radiotherapy under provisions of Medical Devices Rules 2017. CDSCO under provisions of Medical Devices Rules 2017 has classified 101 medical devices related to Radiotherapy. Applicants now can refer to this classification for guidance while submitting registration application.

CDSCO Notice No. File No. 29/Misc./03/2020-DC (197): Classification of Medical Device pertaining to Respiratory under the provisions of Medical Devices Rules, 2017 was issued on 6th August. CDSCO under provisions of Medical Devices Rules 2017 has classified 51 medical devices related to Respiratory. Applicants now can refer to this classification for guidance while submitting registration application.

CDSCO Notice No.File No. 29/Misc./03/2020-DC (196): Classification of Medical Device pertaining to ENT under the provisions of Medical Devices Rules, 2017 was issued on 6th August. CDSCO under provisions of Medical Devices Rules 2017 has classified 67 medical devices related to ENT. Applicants now can refer to this classification for guidance while submitting registration application.

CDSCO Notice No. File No. 29/Misc./03/2020-DC (187): Classification of Medical Device pertaining to Ophthalmology under the provisions of Medical Devices Rules, 2017 was issued on 6th August. CDSCO under provisions of Medical Devices Rules 2017 has classified 135 medical devices related to Ophthalmology. Applicants now can refer to this classification for guidance while submitting registration application.

On 23rd August, CDSCO classified medical devices pertaining to dental/dentistry under provisions of Medical Devices Rules 2017. CDSCO under provisions of Medical Devices Rules 2017 has classified 73 medical devices related to dental/dentistry. Applicants now can refer to this classification for guidance while submitting registration application. Please see below link for more details.

On 23rd August, CDSCO classified medical devices pertaining to Obstetrics and gynaecology under provisions of Medical Devices Rules 2017. CDSCO under provisions of Medical Devices Rules 2017 has classified 107 medical devices related to Obstetrics and gynaecology. Applicants now can refer to this classification for guidance while submitting registration application.

CDSCO Notice No. File No. 29/MiscJ03/2020-DC (150): Classification of Medical Device pertaining to Pediatrics and Neonatology under the provisions of Medical Devices Rules, 2017, was issued on 23rd August. CDSCO under provisions of Medical Devices Rules 2017 has classified 136 medical devices related to Paediatrics and Neonatology. Applicants now can refer to this classification for guidance while submitting registration application.

CDSCO Notice No. File No. 29/Misc./03/2020-DC (145): Classification of Medical Device pertaining to Urology under the provisions of Medical Devices Rules, 2017, was issued on 23rd August. CDSCO under provisions of Medical Devices Rules 2017 has classified 88 medical devices related to Urology. Applicants now can refer to this classification for guidance while submitting registration application.
Malaysia
Importation and distribution of COVID-19 self-test kit through conditional approval. The Medical Device Authority (MDA) wishes to inform that any company wishing to import and distribute the Covid-19 Self-Test Kit must apply through a Conditional Approval Application. Please be informed that any company wishing to import and distribute covid-19 self-testing kit, must have a valid establishment license issued by MDA.Covid-19 Self-Test kits that have received Conditional Approval from MDA can only be sold at licensed community pharmacies or health facilities only. Sale of Covid-19 Self-Test Kits online is only allowed to registered pharmacies and health facilities subject to manufacturer's instructions regarding safe distribution methods to ensure the safety and effectiveness of test kits can be maintained up to consumers.
Philippines
FDA Circular No. 2020-024-B: Supplemental Guidelines to FDA Circular No. 2020-024-A, Entitled "Amendment to FDA Circular No. 2020-024, Entitled 'Updated Guidelines for Application of Authorizations at the Food and Drug Administration in light of the Community Quarantine Declarations' was released on 22nd July. The regulation provides guidance on the following: 1) Existing licenses, certifications, related documents expiring on 1 July 2021 to 31 Dec 2021 are automatically extended by four (4) months from the original date of expiration. 2) Failure to submit the appropriate renewal applications within the extension period but has done so within 120 days from the extended validity date will only incur surcharges on top of the original renewal fee. 3) Failure to successfully apply for renewal after this period shall render the authorization invalid and subject to initial filing application procedures.
South Korea
MFDS Document for Public Comment: MFDS Announcement No. 2021-251: Administrative Advance Notice on Abolition of Provision on Pre-Review of Medical Device Advertising Materials (Draft) was released on 19th July. This is following regulation change according to Medical device Act change not to require advertisement on medical device anymore and conducted by voluntary review agency.

Law No. 18319: Medical Device Act, Revised version was released on 20th July. The purpose of this Act is to promote the efficient management of medical devices and further contribute to the improvement of public health by providing for matters concerning the manufacturing, import, distribution, etc. of medical devices. The following revisions have been made: 1. The number of members of the Medical Device Committee will be increased from the current 100 to 200, and the chairperson of the committee shall be jointly chaired by the Deputy Minister of Food and Drug Safety and a private member appointed by the Minister of Food and Drug Safety (Art. 5). 2. The manufacturer imposes an obligation not to let the quality manager engage in work if he or she has not received training, and the training must be conducted at an institution designated and notified as an educational institution by meeting the standards according to laws and regulations on professional manpower and facilities (Art. 6-2). 3. The provision of economic benefits is prohibited even for those entrusted with sales or rental promotion business by medical device manufacturers, etc., and an expenditure report on the details of provision is made and disclosed (Art. 13, 13-2 and 18). 4. For medical devices inserted into the human body, medical devices that are likely to deteriorate when opened, the manufacturer/importer is obligated to seal them, and sealed medical devices cannot be opened and sold (Art.18-2 and 25-5) 5. Establishment of legal basis for license revocation and imposing penalties in cases where license, etc. has been obtained by fraudulent or other illegal means (Art. 36). 6. Allowing a penalty surcharge to be imposed on a person who manufactures or imports medical devices for harm, up to twice the sales amount of the relevant item (Art. 38-2). 7. Medical device manufacturers/importers are obliged to purchase insurance or mutual aid in order to compensate for damage caused to patients due to side effects of medical devices (Art. 43-6). This Law enters into force six months after its promulgation. However, Articles 31, 36-1-1-2 through 1-4, 14-3, 14-4, 38-3, 39, 43-2, 51-1 and 52-1 shall take effect from the date of promulgation, and the amended provisions of Articles 36-1-21-2 and 43-6 shall take effect one year from the date of promulgation. Among the amended provisions of Art. 13-2, the disclosure of expenditure reports shall be effective two years from the promulgation. This document replaces Law No. 17978: Medical Device Act, Revised version, 23-Mar-2021 (IDRAC 327959). 
 
MFDS Document for Public Comment: MFDS Announcement No. 2021-362: Administrative Advance Notice on Partial Amendment of Provision on Labeling and Management of Unique Device Identifier (UDI) for Medical Devices (Draft) was released on 26th July. The purpose of this document is to solicit public comments on MFDS Notification No. 2018-109: Establishment of Provision on Labeling and Management of Unique Device Identifier (UDI) for Medical Devices, 21-Dec-2018 (IDRAC 288537). The following changes are being proposed: 1. Improvement of the ease of reporting the supply history by requiring readable characters even when displaying or affixing a standard medical device code in the form of a data matrix barcode (Art. 5). Deadline for comments: 16-Aug-2021. 
 
On 27th July, MFDS legislated Law No. 18365: Act on Risk Assessment of Human Body Applied Products. There are safety issues of hazardous substances that the public can frequently be exposed to through various routes such as food, livestock and marine products, drugs and quasi-drugs in daily life, such as fipronil component of the recent pesticide egg wave, humidifier disinfectant, and physiological VOCs (volatile organic substances). Currently, as the risks of products applied to the human body, such as food, cosmetics, pharmaceuticals, quasi-drugs, and hygiene products, are evaluated and managed individually, focusing on the products, according to the laws under the jurisdiction of each product, it is difficult to comprehensively judge the risk. In addition, even if the result of the risk assessment of an individual product is safe for the human body, the total amount of harmful substances ingested and exposed through the entire human body application product may be harmful. Therefore, it is necessary to establish a management system by synthesizing various exposure routes, evaluating the risks of products applied to the human body, and setting safety standards accordingly. It is intended to contribute to the improvement of public health by enacting a separate law and converting it to a system that comprehensively implements the comprehensive risk assessment and management of products that are closely related to the daily life and health of the people. The law is implemented 6 months after its promulgation date 28-Jan-2022. Medical Device is also one of the scope. MFDS can select products or materials which need to assess on toxicological risk.

MFDS released the guideline: Guide-0953-02: GMP Guide for Manufacturing Process of 3D Printing Patient-Customized Medical Devices (Modeling Sector) on 3rd August. As the number of approvals and production of patient-customized medical devices manufactured with 3D printing technology, one of the core technologies of the 4th industrial revolution, increases, this guideline aims to present manufacturing and quality control techniques that can be applied to the manufacture of medical devices. Its purpose is for the device 3D printing manufacturers to easily understand the relevant contents.I. Purpose and Application Scope II. Terminologies III. Related Regulations IV. GMP Application for 3D Printing Process Technology 1. Quality Management System 2. Management Responsibility 3. Resource Management 4. Product Realization 5. Measurement, Analysis and Improvement V. 3D Printing Manufacturing Process (Modeling) VI. References VII. Annex The purpose of this revision was to align the guideline with most current regulations. This document replaces Guideline: Guide-0953-01: GMP Guide for Manufacturing Process of 3D Printing Patient-Customized Medical Devices (Modeling Sector), 28-Jun-2019 (IDRAC 296462). 
Sri Lanka
On 20th August, The National Medicines Regulatory Authority has decided to extend the validity of certificates of registration, manufacturing and import licenses pertaining to Medicines and Medical Devices for a period of one year. This extension can be considered for the certificates of registration and licences expired after 30th of June 2019 and would be expired up to 31st December 2021. This extension is applicable for re registration and renewal applications only. Marketing authorization holders should apply for extension of each certificate of registration and licence before 31st October 2021. Special note instruction for medical device online application 6 month prior to expiry of extension is ambiguous and should be simplified.
Vietnam
Management of import of refurbished goods. This Decree provides for the import of refurbished goods under the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (hereinafter referred to as the CPTPP) and on the List of Used Goods banned from imports from Member Countries into Vietnam.
 
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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