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|