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

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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|

Indonesia: Government Regulation PP No. 64 of 2019 on the Change of Tariffs on Registration Renewal

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The Ministry of Health Indonesia has implemented a new tariff on medical device registration renewal with amendment. This new tariff was enacted on the 17th October 2019 after regulation PP No. 64 of 2019 was released.

The Indonesia government has issued a new regulation namely PP No. 64 of 2019 concerning Types and Rates of Non-Tax State Revenues that apply to the Ministry of Health (MoH), which was previously regulated in PP No. 21 of 2013. This new regulation was promulgated on 17 September 2019, and it start implemented 30 days after promulgated, that’s mean since 17 October 2019.
This change of tariff already Socialize by MoH to all distributors in Indonesia. Socialization held by MoH more focused on the information about the change tariff for the Renewal with Amendment.

Below is the tariff changes information.
1. The services of Medical Devices Marketing Authorization

*) PP PNBP No. 21 of 2013: there is an increase of IDR 500,000 for Renewal with Amendment

2. The services of Household Health Supplies (PKRT) Marketing Authorization

*) PP PNBP No. 21 of 2013: there is an increase of IDR 500,000 for Renewal with Amendment

Criteria of change notification or amendment of medical device are as follows:
1. Size
Including addition or reduction of product content and/or size

2. Packaging, including
– Increase or decrease of packaging size
– Addition or reduction of packaging types
– Design change in package shape
– Changes in packaging material

3. Marking
– Language changes in the instructions for use (instructions for use) and/or packaging
– Changes to the logo or symbol, including the halal logo, quality management system, CE, and company logo.
– Changes to product expiration date if stated in the designation
– Changes to product code/type
– Changes in storage temperature
– Improvements to the product name
– Designation of designation markings (color, image, text and layout)1. Size, including:
– Addition or reduction of product content and/or size

4. Accessories/attachments on marketing authorization:
– Accessories
– Type
– Product code
– Product Size

5. Name and/or address of the representative authorized by the Manufacturer, including:
– Change in the name and/or legal address of the manufacturer
– Change in legal entity
– Change in manufacturer’s address due to changes in urban planning
– Change the manufacturer’s name as long as the manufacturer’s address does not move/ change the location
– Change the name of the distributor if the Tax ID Number (NPWP) and business permit number (NIB) do not change
– Change of address of the distributor who moved the province

6. Writing on marketing authorization (typo)

Criteria of change notification or amendment of PKRT device are as follows:
1. Size (for certain products)
2. Packaging
3. Marking
4. Principal’s name and/or address that is not an acquisition, without a change in manufacturer’s name, for imported PKRT.
5. Other changes that do not affect PKRT’s specifications and claims

2019-12-03T04:58:19+08:00 November 26th, 2019|Insight, Medical Regulation Updates, News & Events|

Medical Device-Drug Combination Product Registration in Malaysia

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A guideline for the registration of drug-medical device and medical device-drug combination products has been released and was fully implemented in Malaysia on 1st July 2019. This article focuses only on Medical Device-Drug Combination Products (MDDCP).

On the 20th June 2019, a guideline for the registration of drug-medical device and medical device-drug combination products was released. This guideline was fully implemented on the 1st July 2019. This article focuses only on Medical Device-Drug Combination Products (MDDCP). MDDCP is where the primary mode of action on the human body is not based on pharmacological, immunological or metabolic means, but is assisted by the device to the extent that the Medical

The Medical Device Authority (MDA) is the primary agency of the combination product. All medical devices with substances incorporated, that when used on their own could be considered a medical product, must comply with this regulation. All medical devices that fall under Class D, Rule 13 of the Medical Device Regulations 2012 shall conform to this new directive.

Some examples of medical devices that fall under this section include but are not limited to soft tissue filler or dermal filler that incorporates local anesthetic, synthetic fluid tissue reconstructive material that incorporates a pharmacologically active substance, root canal filling incorporating antibiotics, drug-eluting stents, drug-eluting beads, general-body orifice lubricant incorporating local anesthetic and enteral feeding kits that contain an iodine pack drug.

For a medical device-drug combination product registration, where the MDA acts as the primary agency, the registration process shall undergo 3 stages:
• Stage 1 – Obtaining Endorsement from the National Pharmaceutical Regulatory Agency (NPRA)
• Stage 2 – Obtaining Certificate from the Conformity Assessment Body (CAB)
• Stage 3 – Application for Registration to the Medical Device Authority (MDA)

Stage 1 – Obtaining Endorsement from the NPRA
Applicant shall submit the following documents to the NPRA manually:
1. Application form for Endorsement Letter of Ancillary Component for Registration of Combination Product (Appendix 3)
2. Ancillary Drug Dossier (Appendix 2)
Note: for the specific labelling requirement, please refer to Appendix 9: Labelling Requirements, released by the NPRA.
Upon satisfactory evaluation, the NPRA shall issue an endorsement letter.

Stage 2 – Obtaining Certificate from the Conformity Assessment Body (CAB)
Applicants shall submit the documentation to the CAB. The CAB shall issue a certificate and report upon satisfactory conformity assessment.

Stage 3 – Application for Registration to MDA
Once the applicant has obtained the endorsement letter from the NPRA, certificate and report from the CAB, an application (in accordance with the Medical Device Regulation 2012) shall be made on Medcast 2.0 for the MDA to evaluate the medical device application. The MDA shall register the Medical Device-Drug combination product and issue a medical device registration certificate upon approval.

2019-12-03T05:22:33+08:00 November 25th, 2019|Event, Medical Regulation Updates, News & Events|

CT-MRI Society of the Philippines Conference

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Thousands attended the 2019 joint conference held by the CT-MRI Society of the Philippines and Ultrasound Society of the Philippines event to discuss scientific programs that involve new treatments, therapies, techniques, as well as new ground-breaking technology and innovation.

The CT-MRI Society of the Philippines and Ultrasound Society of the Philippines held its 2019 Joint Annual Convention with the theme “Basic and Advanced Imaging: Heading Down to Sound Decisions” on October 24-26, 2019 at the Manila Hotel’s Fiesta Pavilion. Thousands of radiologists, radiologic technologists, trainees from the government and private sector, as well as foreign delegates and speakers attended this event to discuss scientific programs that involve new treatments, therapies, techniques, as well as new ground-breaking technology and innovation.

The convention was sponsored by some of the notable medical device companies in the Philippines. In addition, exhibitors from the medical device industry that supply diagnostic imaging medical devices attended the 3-day event. Participant exhibitors showcased their products and took the opportunity to meet with their end-user clients and prospects to promote their products and services as well as create brand awareness.

2019-11-01T05:29:40+08:00 October 29th, 2019|Event, Insight, News & Events|

Reminder of Medical Device status of Non-Corrective Contact Lenses in Malaysia

Contact lenses

Non-corrective contact lenses are also known as cosmetic, decorative, colored or fashion contact lenses. This is a gentle reminder to those non-corrective contact lens manufacturers to register their contact lenses with the Medical Device Authority (MDA) before the devices are placed on the market.

Non-corrective contact lenses were regulated as medical devices by the MDA in Malaysia as of the 1st of January 2018. This is a gentle reminder to those non-corrective contact lens manufacturers to register their contact lenses with the MDA before the devices are placed on the market.
Non-corrective contact lenses are also known as cosmetic, decorative, colored or fashion contact lenses in the market. According to the Medical Device (Declaration) Order 2017, released on the 14th of September 2017, “non-corrective contact lens” means a contact lens which is not used to correct, remedy or relieve any refractive abnormalities or optical defects of sight. Non-corrective contact lenses are used to change the look or color of a user’s eyes. Unlike corrective contact lenses, they do not correct vision.

Non-corrective contact lenses, just like corrective contact lenses can pose serious risks if they are obtained without a prescription or not used correctly. The risks include:

• A cut or scratch on the top layer of the eyeball (corneal abrasion)
• Allergic reactions like itchy, watery red eyes
• Blindness
• Decreased vision
• Infection

All types of contact lenses have associated risks. Thus, the MDA regulate non-corrective contact lenses as medical devices. Manufacturers of non-corrective contact lenses shall obtain ISO 13485 certification. According to the Medical Device Regulations 2012, non-corrective contact lenses shall be considered as Class B or C medical devices, depending on the duration of use.

2019-11-01T05:37:42+08:00 October 29th, 2019|Insight, Medical Regulation Updates, News & Events|

Vietnam National Single Window as a Singular Product Registration Website

Halal

The Ministry of Health (MoH) of Vietnam has introduced a new feature on their registration website system (the Vietnam National Single Window) that combines two registration systems – import and product license – into one website.

Previously, a registrant had to (1) register on the Vietnam National Single Window website (VNSW) for an import license, and (2) set up an account on the Department of Medical Equipment and Construction website (DMEC) for a product license. As of mid-October 2019, one account in VNSW will be sufficient for both import license and product license registration. The system is currently being trialled on the site; the official system will be implemented on January 1, 2020.

According to the authorities, the registration number on the dossier submitted via the Department of Medical Equipment and Construction (DMEC) will not change, thus no update is required. The system will automatically transfer the information to VNSW for follow-up and to receive feedback from the previewer. By using the VNSW to send information and electronic documents, customs declarants can carry out customs procedures in addition to procedures of the state management agencies related to exported and imported goods through one integrated information system.

State management agencies decide whether goods should be allowed to be exported, imported or transited; customs authorities decide customs clearance and release goods on the integrated information system. The list of administrative procedures of medical equipment registration after implementation includes:

1. Issuing an import license for medical equipment
2. Issuing a product license for medical equipment
3. Assigning a certificate of trading class B, C, D medical equipment
4. Granting a Certificate of Free-sale
5. Announcement of eligibility for classification of medical equipment
6. Obtaining a medical equipment classification practice certificate
7. Announcement of eligibility for technical services of medical equipment
8. Announcement of facilities eligible for testing and calibration of medical equipment
9. Announcement of eligibility for production of medical equipment

2019-11-01T05:42:45+08:00 October 29th, 2019|Insight, Medical Regulation Updates, News & Events|

Malaysia Medical Device Expo (myMEDEX) and International Medical Device Conference (IMDC) 2019

Malaysia Medical Device Expo

The opening ceremony for these events was launched by the Prime Minister of Malaysia, Tun Dr. Mahathir bin Mohamad, in the presence of the Minister of Health, Datuk Seri Dr. Dzulkefly Ahmad. The Prime Minister said that Malaysia could strengthen its global market competitiveness by providing a conducive business environment for multinational companies.

The Malaysia Medical Device Expo (myMEDEX) and International Medical Device Conference (IMDC) were held concurrently at the Malaysia International Trade & Exhibition Centre (MITEC) from the 15th October 2019 to 17th October 2019.

The opening ceremony was launched by the prime minister of Malaysia, Tun Dr. Mahathir bin Mohamad, in the presence of the Minister of Health, Datuk Seri Dr. Dzulkefly Ahmad. Prime Minister Tun Dr. Mahathir bin Mohamad said that Malaysia could strengthen its global market competitiveness by providing a conducive business environment for multinational companies. Besides that, Tun Dr. Mahathir stated that Malaysia is the world’s largest producer and leading exporter of rubber gloves, contributing 63% of the global supply while the export revenue was projected to reach a total of RM19.88 billion in 2019.

On the first day of the International Medical Device Conference (IMDC), a few well-known speakers were invited to provide a presentation. Ms. Quan Tran gave a presentation focusing on the ASEAN Medical Device Directives, and Mr. Thomas Stefen Brand gave a talk on the “Challenges of the New European Union Medical Device Regulations for Medical Device Companies”. Later that day, the participants were given three tracks to choose to attend: regulatory requirements, medical device research environment, or state of the arts.

On the second day of the event a few topics were presented, including Global Strategy for Digital Health, R&D&C&I of Medical Device in Malaysia, Unlocking Innovation in Healthcare, Spearheading Healthcare Innovation with Internet of Things and Big Data, and Supporting Innovation and Faster Access to Safe Medical Devices. In the afternoon, the Medical Device Authority (MDA) in Malaysia updated the industry players on the new regulations, focusing on the re-registration requirements, prohibition order & advertisement, and post-market, surveillance & vigilance (PMSV) & enforcement. The group discussed the possible routes taken by the Authority to implement the regulation. It is expected that new regulations will be introduced in year 2020.

With the conclusion of myMEDEX and IMDC, the government hopes that industry players can continue innovating and revolutionizing processes and business models in the medical devices industry.

2019-11-01T06:02:32+08:00 October 29th, 2019|Insight, Medical Regulation Updates, News & Events|

Malaysia: Control of Orphaned, Obsolete and Discontinued Medical Devices in Hospitals, Healthcare Institutions or Any Related Facilities

Halal

On 28th July 2019, the Medical Device Authority (MDA) in Malaysia released a revision of the circular letter, dated 22nd May 2018, on the control of orphaned, obsolete and discontinued medical devices in hospitals, healthcare institutions or any related facilities. According to the circular letter, an orphaned, obsolete and discontinued medical device is exempt from medical device registration and establishment license requirements; however, healthcare facilities that are in possession of orphaned, obsolete or discontinued medical devices must provide a notification/listing to the Medical Device Authority.

On 28th July 2019, the Medical Device Authority (MDA) in Malaysia released a revision of the circular letter, dated 22nd May 2018, on the control of orphaned, obsolete and discontinued medical device in hospitals, healthcare institutions or any related facilities.

An orphaned medical device is an existing medical device in a hospital, healthcare institution or any related facility that is not registered under Act 737 as it no longer has the manufacturer or authorized representative to register the medical device. Obsolete medical devices are outdated medical devices that are no longer used due to design changes or the evolution of new technologies etc. Discontinued medical devices are medical devices that are no longer distributed in the market or are no longer being produced.

According to the circular letter,
a) An orphaned, obsolete and discontinued medical device is exempt from medical device registration and establishment license requirements
b) Establishments or healthcare institutions in possession of orphaned, obsolete or discontinued medical devices must provide a notification/listing to the Medical Device Authority
c) The risk of using orphaned, obsolete and discontinued medical devices the responsibility of the establishment, users and healthcare institution
d) Establishments shall be responsible for post-market issues associated with any obsolete or discontinued medical device for the projected useful life of the medical device as determined by the manufacturer
e) Compliance is required with notification requirements as specified by the Authority

This circular letter shall be used as part of requirements under Act 737 and shall be effective from the date it is issued. The revised circular letter can be referred to here and the original circular letter released in 2018 can be referred to here.

2019-10-02T04:16:12+08:00 September 28th, 2019|Insight, Medical Regulation Updates, News & Events|

International Medical Device Conference (IMDC) and Malaysia Medical Device Expo (myMEDEX)

Halal

The Medical Device Authority (MDA) in Malaysia is organizing both IMDC and myMEDEX to be hosted at the Malaysia International Trade and Exhibition Centre (MITEC), Kuala Lumpur, Malaysia from 15 to 17 October 2019. The target audience for these 3-day events includes regulators, industry representatives, researchers, clinicians and members of academia.

The International Medical Device Conference (IMDC) 2019 and Malaysia Medical Device Expo (myMEDEX) 2019 will be held in Kuala Lumpur, Malaysia this October. The Medical Device Authority (MDA) is organizing both IMDC and myMEDEX to be hosted at the Malaysia International Trade and Exhibition Centre (MITEC), Kuala Lumpur, Malaysia from 15th October 2019 (Tuesday) to 17th October 2019 (Thursday). The target audience for these 3-day events includes regulators, industry representatives, researchers, clinicians and members of academia.

The International Medical Device Conference 2019 will provide a forum for medical device regulators, healthcare institutions, healthcare service providers, research institutes, conformity assessment bodies, training bodies, medical device testing laboratories and stakeholders to discuss and share experiences on regulations and quality and safety of medical devices. The purpose of this Forum is to provide a platform for regulators and stakeholders of the medical device industry worldwide to meet and receive updates on current affairs pertaining to the medical device industry.

The Malaysia Medical Device Expo is an initiative by the MDA to highlight the latest innovative technologies and advances of global medical devices. The aim is to create an insightful one-stop center for medical device solutions. The medical device industry is one of the largest industries in global healthcare.

For more information on IMDC 2019, contact the IMDC 2019 secretariat at the following email address: imdc2019@mda.gov.my or on +603 8230 0300.

For more information on myMEDEX 2019, contact the myMEDEX secretariat at the following email address: info@mymedex.com.my or on +603 8070 7666.

2019-10-02T04:13:15+08:00 September 28th, 2019|Event, News & Events|