FDA officially issued the Circular for Initial Implementation of AO 2018-002.

advertising

Circular 2020-001 aims to provide information regarding the acceptance of applications based on AO 2018-002, validity of issued Certificate of exemption, and application fees for marketing authorizations. It also provides guidance regarding the classification of medical devices listed in FDA Memo Circular 2014-005 and 2014-005A according to the risk level.

FDA Circular 2020-001: Initial Implementation AO 2018-002: Guidelines Governing the Issuance of An Authorization for a Medical Device Based on the ASEAN Harmonized Technical Requirements, was issued by the Food and Drug Administration in the late afternoon January 24, 2020.

The Circular aims to provide information regarding the acceptance of applications based on AO 2018-002, validity of issued Certificate of exemption (COE), and application fees for marketing authorizations. It also aims to provide guidance for the medical device industry and all concerned regarding the classification of medical devices listed in FDA Memo Circular 2014-005 and FDA Memo Circular 2014-005A according to the level of risk.

Specific policies and guidelines of the circular are outlined as follows:
1.) FDA CDRRHR shall be accepting applications for the following marketing authorizations:
 Certificate of Medical Device Registration (CMDR) for Class B, C, and D included in the FDA Memorandum Circular 2014-005 and 2014-005A (see Annex A).
 Certificate of Medical Device Notification (CMDN) for all Medical Devices with risk classification A whether or not included in FDA Memorandum Circular 2014-005 and 2014-005A.
 Certificate of Medical Device Listing (CMDL) for research, clinical trial, exhibit, personal use and/or donated, brand new medical devices.
2.) Classification of Medical Devices not included in Annex A shall follow the classification rules of AMDD.
3.) All COE for Class A medical Devices issued from Feb 25, 2014 shall remain valid only until Nov 3, 2021 or within 2 years from date of effectivity of the Circular whichever is earlier.
4.) All CPR issued for Class A Medical Devices shall be deemed equivalent to CMDN only until validity of the CPR. CMDN shall be issued upon renewal of the issued CPR.
5.) Blood collection tube shall be added under the list of IVD since it has been re-classified as in-vitro diagnostic (IVD) medical devices based on definition of IVD in the ASEAN AMDD.
6.) Issuance of COE shall cease. All Class B, C and D medical devices not included in Annex A and IVD not included in FDA Memo Circular 2014-005 shall be considered non-registrable products. The License to Operate of establishment shall be provided in lieu of COE at the point of entry and/or as part of the bidding requirement.
7.) The fees shall be in accordance with AO 50s. 2001, until such time of modification, supersession, and/or revocation, with the following clarification:
a. Initial application CMDN & CMDR is Php 7,500 + 1% Legal research fee (LRF) x 5 years
b. Renewal applications of CMDN & CMDR is Php 5,000 + 1% Legal research fee (LRF)
c. Application for CMDL is Php 500 + 1% Legal research fee (LRF)
8.) Additional details shall be provided in subsequent issuances regarding the succeeding phases.
Effectivity of the circular shall take effect 15 days after its publication in a newspaper of general circulation and upon acknowledgement of receipt of a copy hereof by the Office of the National Administrative Register.

2020-02-03T09:26:13+08:00 February 3rd, 2020|Insight, Medical Regulation Updates, News & Events|

The Role of the Ministry of Health Directorate of Surveillance in improving the Quality, Safety and Efficacy of Medical Devices in Indonesia

advertising

In order to guarantee that medical devices and household health supplies meet quality, safety and efficacy requirements, products must obtain a marketing authorization number. This is evaluated by the Directorate of Assessment, Indonesia prior to product distribution

Based upon the Ministry of Health (MoH) regulatory PERMENKES No. 64 of 2015 (concerning the Organization and Work Procedures of the MoH), the Directorate of Production and Distribution of Medical Devices is divided into two directorates:
1. Directorate of Assessment of Medical Device and Household Health Supplies;
2. Directorate of Surveillance of Medical Device and Household Health Supplies

After a product receives a marketing authorization number from the Directorate of Assessment, it can be distributed. At this stage, it is the task of the Directorate of Surveillance to provide supervision of the distributed product. The purpose of supervision is to ensure that medical devices and household health supplies meet the appropriate standards and/or requirements, thereby preventing and controlling any potential consequences that arise from misuse and abuse. This also provides legal certainty, creates a healthy business climate and furthermore, protects the public from the dangers of using medical devices and household health supplies that do not meet the quality, safety and efficacy requirements.
The activities conducted by the Directorate of Surveillance to achieve the aforementioned purposes are listed below:

1. Sampling and Testing
Sampling and testing are conducted by MoH Surveillance when a product is widely used by the public or, when a product has experienced an adverse event. These aim to protect the public from using products that do not meet quality and safety requirements and to ensure product consistency. It also serves as a way to detect the presence of fake or illegal products.

2. Advertising and Labelling Control
Supervision of advertising and labelling are conducted with the aim of protecting the public from misleading information, avoiding dangers/adverse effects, preventing harm to the environment, and preventing material and immaterial losses due to improper use.  Advertising and labelling are required to be objective, ethical and should not use misleading information or language that can be open to interpretation.

3. Vigilance System Supervision
Vigilance System Supervision is part of the Medical Device Supervision with the aim of preventing the recurrence of the same event and to correct any unexpected event. An unexpected event can still occur with products despite passing the assessment stage. An unexpected event is defined as one in which serious injury, death or deterioration in the health of patients, users or others is caused directly or indirectly by a product defect (damage or failure, decreased performance, or inadequate marking or instructions for use).  Events can be reported by distributors, health service facilities, and the public/patients users of the product.

4. Clinical and Technical Information Audit
This activity is also included in the role of MoH Directorate Surveillance.

2020-02-03T01:34:16+08:00 February 3rd, 2020|Insight, Medical Regulation Updates, News & Events|

A notification from the Ministry of Public Health Thailand: Medical Device Risk Base Classification 2019 Effective date 19th December 2019

advertising

The Ministry of Public Health Thailand has published the medical device risk base classification to conform to the ASEAN Agreement on Medical Device Directive (AMDD). This came into effect on the 19th December 2019.

Refer to the Medical Device Act 2008 and the 2nd revision Medical Device Act 2019, there are some modifications as the following:

1) Classify the medical devices into 2 groups
1.1 In Vitro Diagnostic (IVD) Medical Devices
1.2 Non-In Vitro Diagnostic (Non-IVD) Medical Devices

2) To classify IVD medical devices by risk base to individual and public health from low risk to high risk
2.1 Class 1 Medical Device: Low individual risk and Low public health risk
2.2 Class 2 Medical Device: Moderate individual risk and/ or Low public health risk
2.3 Class 3 Medial Device: High individual risk and/ or Moderate public health risk
2.4 Class 4 Medical Device: High individual risk and High public health risk

3) To classify Non-IVD medical devices by risk base that might be occurred from low risk to high risk
3.1 Class 1 Medical Device: Low risk
3.2 Class 2 Medical Device: Low-Moderate risk
3.3 Class 3 Medical Device: Moderate-High risk
3.4 Class 4 Medical Device: High risk
4) TFDA secretary department has authorize to finalize the medical devices classification should there be any issues of medical devices classification
5) There are Medical Device Control for the risk base medical devices classification
5.1 Licensed Medical Devices CSDT Submission
5.2 Notified Medical Devices  CSDT Submission
5.3 Listing Medical Devices* (e-Listing) Non-CSDT Submission
*Amendment of Medical Device Act 2008

6) This notification will be effective on the day after the publication of Thai government gazette
The regulation (Thai version).

MDCD official launch of Medical Devices Risk Classification Tool (Thai version) which is now available online HERE.

2020-02-03T01:28:55+08:00 January 28th, 2020|Insight, Medical Regulation Updates, News & Events|

Philippines Food and Drug Administration (FDA) releases a draft schedule of fees for Licensing, Registration and Regulatory Services for public comments

advertising

The new draft schedule of fees and charges shall apply to all persons, establishments and health products under the FDA’s jurisdiction. This includes, but is not limited to, national and local government agencies, state colleges and universities, public schools, private entities, and non-governmental organizations who utilize the FDA’s services.

The FDA is rationalizing and streamlining its fee structure to strengthen regulatory enforcement and post-marketing surveillance activities, and to address rising operational costs and expenses for qualified personnel who have technical skills in the evaluation of health products, inspection of establishments and/or laboratory testing. Furthermore, it also aims to sustain the cost of the development, maintenance, and upgrading of information and communication technology and online systems.

The draft new schedule of fees and charges shall apply to all persons, establishments and health products under the FDA’s jurisdiction. This includes, but is not limited to, national and local government agencies, state colleges and universities, public schools, private entities, and non-governmental organizations availing of the FDA’s services.

The new schedule of fees and charges applicable to the Center for Device Regulation, Radiation Health and Research (CDRRHR) is outlined below. The application fees shall not cover the University of the Phillipines Law Center’s Legal Research Fee (LRF), which is equivalent to Php 10.00 or 1% of the application fee, whichever is higher, and the fees incurred from the use of payment collection facilities, such as service fees charged by banks authorized to collect fees on behalf of the FDA.

The application fees for granting the authorization stated in the draft issuance shall cover the expenses of all or any of the following activities:

1) Receiving of application documents;
2) Pre-assessment of received applications for product market authorizations;
3) Pre-marketing activities, including but not limited to assessment, technical evaluation and pre-licensing inspection of establishment;
4) Post-marketing surveillance of products and establishments: (a) Collection of samples (b) Laboratory testing (c) Complaints and reports processing (d) Safety monitoring (e) Post-licensing inspection (f) Routine inspection (g) Pharmacovigilance
5) Printing;
6) Records management and archiving; and
6) Courier services to deliver the authorization.

The FDA plans to implement these revised fees in 2020 (except as otherwise stated in its Annexes).

2020-02-04T13:48:34+08:00 January 28th, 2020|Insight, Medical Regulation Updates, News & Events|

Malaysian Medical Device (Duties and Obligations of Establishments) Regulations 2019

advertising

The Malaysian Ministry of Health has recently released a regulation on the Duties and Obligations of Establishments of medical devices. The regulations will come into effect on the 1st July 2020.

.

The categories of the duties and obligations that are imposed in this regulation are as follows:

1. Distribution records
This section highlights the contents required for a distribution record, the contents required for an implantable medical device distribution record and the period of maintenance required for a distribution record.

2. Records of complaint handling
This section focuses on complaint handling procedures and highlights the requirements for a record of complaint handling and the holding of a complaint record.

3. Mandatory problem reporting
The regulation states than an establishment must submit an investigation report to the Authority within thirty days from the date of the submission of the mandatory report. For incidents that occur outside of Malaysia, if it has been reported by the establishment to the regulatory agency of the country in which the incident occurred and a field corrective action has already been taken by the manufacturer or establishment, the requirement to submit a mandatory report does not apply.

4. Field corrective or preventive action
Establishments shall notify the Authority before undertaking field corrective or preventive action. After the field corrective action or preventive action has been completed, the establishment is required to submit a report to the Authority.

5. Voluntary recall
Before an establishment undertakes a voluntary recall of a medical device, the establishment shall notify the Authority and all those affected by the recall of the medical device within the time frames outlined below:
– for a Class I (high risk) recall, no less than forty-eight hours before the recall is made;
– for a Class II (medium risk), no less than three days before the recall is made;
– for a Class III (low risk), no less than five days before the recall is made.

6. Mandatory recall
The Authority may, in writing, order an establishment to recall any medical device at any time for reasons of patient safety and public health. If the Authority is satisfied with the report of the recall (required by the establishment to undertake), the Authority may close the matter and notify the establishment in writing of its decision.

2020-02-03T01:27:30+08:00 January 28th, 2020|Insight, Medical Regulation Updates, News & Events|

Vietnam: Business Dialogue Conference on Management of Medical Equipment Regulations

business dialogue

The Ministry of Health, Vietnam has shared with attendees of a business dialogue that the validity of import licenses and the effective date for product licenses Class B, C and D will be extended. The official announcement has been published on the government website..

The Ministry of Health (Department of Medical Equipment and Construction), Vietnam organized a business dialogue conference (3rd of Dec 2019 in Hanoi and on the 14th of Dec 2019 in Ho Chi Minh city) focussing on the regulations of the management of medical equipment and asked for comments on policies supporting the development of domestic production of medical equipment.

The general guidelines about import licenses and product licenses are:
• The import license is valid until 31st of December 2021 for Class B, C, D medical devices for all import licenses issued in 2018 (valid on 31 December 2018) and all import licenses issued in 2019.
• For Class B, C, D medical devices that do not require an import license, importation can continue as normal until 31st of December 2021 without the requirement for a Confirmation Letter from the Vietnamese Ministry of Health.
• Vietnam will apply the Common Submission Dossier Template format until the 1st of January 2022.

In conclusion, the Ministry of Health will expand the valid date for import licenses until the 31st of December 2021 and, the effective date of product licenses for the next two years (1st of January 2022). Every registrant should understand the medical devices that are being registered and the regulations surrounding these.

The new decree is released to public early this month, January 2020. For further information, please refer to the following website: www.dmec.moh.gov.vn

2020-01-13T11:34:42+08:00 December 29th, 2019|Event, Insight, Medical Regulation Updates, News & Events|

Indonesia: Exemption from Import Duty for Health Services Goods

conference

The import of health goods will normally be subject to a fiscal levy through customs duties and taxes in the framework of import (PDRI). Certain health goods may be exempt of import duties and taxes via the import duty exemption scheme

Goods for health services can be sourced domestically or internationally. Importation of such items can be divided into two: goods obtained from the purchase, and grant goods. The import of health goods will normally be subject to fiscal levy through customs duties and taxes in the framework of import (PDRI). This is likely to increase the price of imported goods. For savings and efficiency, the import of health goods can be provided with fiscal facilities through the exemption of import duties and import taxes (PDRI).

IMPORT DUTY EXEMPTION SCHEME
The procedure for the exemption of import duties for medical goods can differ from one party to another. It is important to distinguish the difference in the subject (recipient of goods), object (type of goods) and the allocation of the intended goods.
In accordance to Article 25 and 26 of Law No. 17 of 2006 concerning The Amendment of Law No.10 of 1995 on customs, health goods can be granted a Customs Exemption Sign using the scheme below:
a. Goods for charity and social purposes;
b. Goods for the sake of natural disaster management.
c. Goods for research and development of Science;
d. Goods for the need of disability;
e. Goods for the Central Government or Local government for public interest.
f. Goods for the need of government projects financed by loans and/or grants from abroad

COSTS INCURRED DURING THE PROCESS OF ISSUING GOODS (CLEARANCE)
In the process of issuing goods from the port, it is possible that costs associated with warehouse rental, handling, etc. may arise. Although the recipient of the goods has obtained the exemption from import duty and PDRI, the exemption is not related to these costs incurred in the process of issuing the goods and cannot be waived . The recipient can anticipate this cost by confirming the carrier and the designated customs broker, PPJK.

AFTER THE GOODS EXIT THE PORT
After the goods are released from the port by obtaining import duty exemption and PDRI, the importer or the receiver still has an obligation to comply with the provisions set forth in the letter ‘Decision on import duty Exemption’. Conditions that the recipient must comply with:
a. The recipient must use the goods in accordance with the provisions specified in the exemption decree of import duty.
b. The goods are not transferable to another party, except with the permission of the Directorate General of Customs and Excise. This is mainly used for items that are not consumables. In the event that the goods are used or intended to be shared (consumed or worn) to the prescribed party, then the handover does not require permission from Directorate General of Customs and Excise (DGCE)
c. The DGCE will conduct monitoring and evaluation for those goods that receive exemption from import duty. In this monitoring and evaluation, the recipient of the goods must be able to show related documents and/or the existence of imported goods.
d. DGCE may also conduct customs audits of importation of goods that obtain Exemption of import duty.

2020-01-13T09:36:12+08:00 December 29th, 2019|Insight, News & Events|

Classification of Medical Devices and In Vitro Diagnostic Devices in India

conference

Medical devices and in vitro diagnostic devices are classified according to the intended use of the device, risks associated with the device, and other parameters specified in the First Schedule

Historically there has been minimal regulation of medical devices in India. However, the medical device industry has changed with the Medical Devices Rules 2017, For the regulation of medical devices with respect to import, manufacturing, clinical investigation, sales and distribution, the Central Government (in consultation with the Drugs Technical Advisory Board) has developed the Medical Devices Rules 2017. This came into effect from the 1st of January 2018 under the provisions of the Drug and Cosmetics Act 1940. The safety and performance of medical devices and in vitro diagnostic devices are regulated under this Act.

Medical devices and in vitro diagnostic devices are classified based on the intended use of the device, risks associated with the device and other parameters specified in the First Schedule. Based on these factors, devices have been categorised into risk classes under the provisions of sub-rule (I), Rule 4 of the Medical Devices Rules 2017. A total of 350 categories of medical devices and 247 categories of in-vitro diagnostic devices have been classified in accordance with the amended Annexure I as of the 6th of June 2018.

Recently, on the 15th of May 2019, further classification of 12 newly notified medical devices have been added to the existing list of classified devices. All these newly notified device types have been assigned moderate to moderate-high Class B and Class C risk classifications:
• CT scan equipment (Class C)
• MRI equipment (Class C)
• Defibrillators (Class C)
• Dialysis machines (Class C)
• PET equipment (Class C)
• X-ray machines (Class C)
• Bone marrow cell separators (Class B)
• Nebulizers (Class C)
• Blood pressure monitoring devices (Class B)
• Digital thermometers (Class B)
• Glucometers (Class C IVD)
• Organ preservation solutions (Class C)

These classifications will come into effect from the 1st of April 2020. These risk classifications will allow the industry to get a better idea of the costs involved, clinical data requirements (if any) and the import licensing authority as they commercialize their products in India.

2020-01-13T09:42:38+08:00 December 29th, 2019|Event, Insight, News & Events|

Andaman Medical Expanding Its Footprint in Asia

conference

Are you looking into seizing an opportunity in India’s medical device market? Andaman Medical India is commencing its operation in 2020. We are excited to assist you in regulatory matters and contribute to your business development in India. We will be sharing more on our new division soon.

India is the fourth largest medical device market in Asia after Japan, China and South Korea. The current medical device market size is estimated to be worth USD 5.2 billion, with projections that India will become the world’s most populous nation by 2024, with a medical device market size between USD 9.3bn to 10.8bn. This provides an opportunity to help to shape the Indian medical device market and to enhance the quality of life of those living in India.

Andaman Medical may be able to help you to seize this opportunity. From 2020, Andaman Medical will expand its footprint in India. We aim to assist you in navigating the complex regulatory requirements by being the local license holder, facilitating registration processes with authorities, providing regulatory intelligence work and business development services.

For medical device regulations in India, the regulatory body responsible for medical device registration is the Central Drug Standards Control Organization (CDSCO). Only notified medical devices shall undergo registration with CDSCO. Currently, there are about 30 medical device product families that require registration. For example, disposable hypodermic needles, catheters, drug eluting stents and bone cements require registration with CDSCO. By the 1st of April 2020, blood pressure monitoring devices, CT scanning equipment, MRI equipment, defibrillators and dialysis machines are some of the devices that are scheduled for regulation.

We look forward to sharing more information on Indian regulatory updates and news of Andaman Medical India.

Andaman Team India

2020-01-13T09:46:56+08:00 December 6th, 2019|Event, Insight, News & Events|

Philippines: A Review of the Importation System, Requirements and Documentation

conference

Importing into the Philippines is straight forward with the guidelines provided by the Bureau of Customs. We explain the importation classifications and the basic requirements for importation.

The importation of certain commodities into the Philippines is either regulated, restricted or prohibited for reasons of public health and safety, national security, international commitments and development/rationalization of local industry. Imports are classified into the following:

  • Free Importation and Exportation – refers to goods that may be freely imported into and exported from the Philippines without the need for import and export permits, clearances or licenses (unless otherwise provided by law or regulation). (Chapter 3, Section 116 Customs Modernization and Tariff Act [CMTA])
  • Regulated Importation and Exportation – goods which are subject to regulation can only be imported or exported after securing the necessary declaration, clearances, licenses, and any other requirements prior to importation. For importation, submission of requirements after arrival of the goods, but prior to release from customs custody, will only be allowed in cases provided for by governing laws or regulations (Chapter 3, Section 117 CMTA). Examples of regulated imports are: food, drugs, cosmetics and medical devices regulated by the Food and Drug Administration.
  • Restricted Importation and Exportation – except when authorized by law or regulation, the importation and exportation of restricted goods listed in Chapter 3, Section 119 of the CMTA are prohibited. Examples of restricted imports are habit forming chemicals/substances such as opium, marijuana, heroin and other narcotic and synthetic drugs.
  • Prohibited Importation and Exportation – the importation and exportation of goods listed in Chapter 3, Section 118 of the CMTA are prohibited. Examples of prohibited imports are adulterated or misbranded food, drug, cosmetics, devices or goods for human consumption in violation of relevant laws and regulations. The list of regulated Import Commodities and their Administering Agencies can be viewed in the Philippine National Trade Repository.

Documentation Required for Importation
The printout of the Single Administrative Document (SAD) signed by both the declarant and the customs broker(and if applicable, duly notarized), must be submitted to the Formal Entry Division (FED) or its equivalent office or unit, with the following documents:
1. Duly endorsed Bill of Landing or Airway Bill, or certification by the carrier or agent of the vessel or aircraft;
2. Commercial Invoice, Letter of Credit or any other verifiable commercial document evidencing payment. In cases where there is no sale for export, a commercial document indicating the commercial value of the goods is required;
3. Packing List
4. Duly notarized Supplemental Declaration on Valuation (SDV);
5. Documents that may be required by specific rules and regulations, such as:
1. Import Permit or Clearance (Ex. FDA LTO, CPR, NTC permit, DDB Exemption);
2. Authority to Release Imported Goods (ATRIG);
3. Proof of Origin for Free Trade Agreements (FTAs);
4. Copy of an Advance Ruling, if the ruling was used in the goods declaration;
5. Load Port Survey Reports or Discharge Port Survey Reports for bulk or break bulk importations;
6. Document evidencing exemption from duties and taxes;
7. Others, e.g., Tax Credit Certificate (TCC) or Tax Debit Memo (TDM).

Lodgement of Goods Declarations.
Those authorized to lodge a goods declaration or make an import entry are as follows:
a) The importer, being the holder of the bill of landing or airway bill. If the importer is a juridical person, they may authorize a responsible officer of the company to sign the goods declaration on their behalf. For a corporation, the responsible officer must be authorized by the Board of Directors to sign as the declarant on its behalf. For a partnership, the responsible officer must be authorized by the partners. For sole proprietorship, the responsible officer must be authorized by the owner, who shall issue a Special Power of Attorney (SPA).
b) A customs broker acting under the authority of the importer or holder of the bill; or
c) A person duly empowered to act as agent or attorney-in-fact for each holder of the bill. The duly notarized power of attorney should be approved by the Port Collector. No more than signing power may be accepted.

Period Within Which to Lodge.
A goods declaration must be lodged within (15) days from the date of discharge of the last package from the vessel or aircraft. The period to lodge the goods declaration may upon request, be extended on valid grounds for another fifteen (15) days subject to the approval of the District Collector. The request must be made before the expiration of the original period to lodge the goods declaration. The period for lodgement of the goods declaration may be adjusted by the Commissioner.

Goods Liable to Duties and Taxes.
All goods, when imported into the Philippines, shall be subject to duty upon importation. These include goods previously exported from the Philippines, except for the following:

  • Those that are conditionally tax and/or duty-exempt importations under section 800, Chapter 1, Title VIII of the CMTA;
  • Those considered as De Minimis importations;
  • Importations of books under the Florence Agreement;
  • Other tax privileges granted by law;
  • Importations under the Customs Bonded Warehousing Systems; and
  • Importations intended for free port zones.

When Importation Begins and when it is deemed Terminated.
Importation begins when the carrying vessel or aircraft enters the Philippine Territory with the intention to unload therein. Importation is deemed to be terminated when:

  • The duties, taxes and other charges have been paid or secured to be paid at the port of entry (unless the goods are free from duties, taxes and other charges and legal permit for withdrawal has been granted); or
  • If the goods are deemed free of duties, taxes and other charges, they have legally left the jurisdiction of the Bureau.
    Selectivity System. Determines the selection of examination procedures based on risk criteria established in the Customs Cargo Clearance System. The Customs Cargo Clearance System assigns the declared goods to one of the following control channels:
  • Red lane – documentary check; and physical examination or non-intrusive inspection, or magna scale weighing (when necessary);
  • Yellow lane – documentary check;
  • Blue lane – to be considered for post clearance audit; or
  • Green lane – released without documentary check and without examination of the goods.

References:
https://www.dti.gov.ph/business/imports/import-facilitation

2019-12-29T17:58:12+08:00 November 27th, 2019|Insight, News & Events|