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MedicalDevice版 - 美国进口医疗器械程序: basics
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话题: fda话题: import话题: product话题: compliance话题: device
进入MedicalDevice版参与讨论
1 (共1页)
s*********e
发帖数: 884
1
Source:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/I
Importing into the U.S.
Please note: as of October 1, 2002, FDA charges fees for review of Premarket
Notification 510(k)s and Premarket Approvals
Overview
Foreign firms that manufacture medical devices and/or products that emit
radiation that are imported into the United States must comply with
applicable U.S. regulations before, during, and after importing into the U.S
. or its territories. In order to import medical devices and/or products
that emit radiation into the U.S., the product must meet FDA regulatory
requirements. FDA does not recognize regulatory approvals from other
countries. The following is a summary of FDA requirements for medical
devices and products that emit radiation.
Medical Devices
Foreign manufacturers
Foreign manufacturers must meet applicable United States (U..S.) medical
device regulations in order to import devices into the U.S. even if the
product is authorized for marketing in another country. These requirements
include registration of establishment, listing of devices, manufacturing in
accordance with the quality system regulation, medical device reporting of
adverse events, and Premarket Notification 510(k) or Premarket Approval, if
applicable. In addition, the foreign manufacturers must designate a United
States agent. As with domestic manufacturers, foreign manufacturing sites
are subject to FDA inspection. Information on U.S. regulatory requirements
can be found in the Device Advice section.
Initial Importers
The initial importer of the device must register its establishment with FDA.
An initial importer is any importer who furthers the marketing of a device
from a foreign manufacturer to the person who makes the final delivery or
sale of the device to the ultimate consumer or user, but does not repackage,
or otherwise change the container, wrapper, or labeling of the device or
device package. Registration information can be found under Establishment
Registration.
Initial importers are also subject to Medical Device Reporting (MDR) under
21 CFR 803, Reports of Corrections and Removals under 21 CFR 806, and
Medical Device Tracking under 21 CFR 821, if applicable. Under the MDR
regulations importers are required to report incidents in which a device may
have caused or contributed to a death or serious injury as well as report
certain malfunctions. The importers must maintain an MDR event file for each
adverse event. All product complaints (MDR and nonMDR events) must be
forwarded to the manufacturer. Under Medical Device Tracking requirements,
certain devices must be tracked through the distribution chain.
Products that emit radiation
Foreign manufacturers that export electronic products (medical device or non
-medical) that emit radiation to the United States are subject to the
requirements of the Federal Food, Drug, and Cosmetic Act, Subchapter C -
Electronic Product Radiation Control (formerly the Radiation Control for
Health and Safety Act of 1968). These requirements include performance
standards, labeling, and submission of radiation safety product reports.
Guidance on these requirements can be found on the Internet under Electronic
Product Radiation Control. When manufacturers submit radiation safety
product reports, the reports are entered into a database and assigned an
accession number (file point). Importers may submit radiation safety product
reports on behalf of manufacturers.
Import Process
All medical devices that are imported into the U.S. must meet Bureau of
Customs and Border Protection (CBP) requirements in addition to FDA. Product
that does not meet FDA regulatory requirements may be detained upon entry.
The major responsibility of CBP is to administer the Tariff Act of 1930 as
amended. Primary duties include assessment and collection of all duties,
taxes, and fees on imported merchandise; administration and review of import
entry forms; the enforcement of CBP and related laws; and administration of
certain navigation laws and treaties. There is a working agreement between
FDA and CBP for the cooperative enforcement of Section 801 of the FD& C Act.
The import process, as shown in the "Import Procedures Flowchart" below,
begins with the importer or filer submitting the necessary entry information
to the local CBP district office. For those entries not filed
electronically, a paper entry consisting of the commercial invoice, CBP
entry forms CF3461/3461ALT and/or CF7501 or documentation that would need to
be provided by the importer or filer.
Entry information should identify the product and include appropriate
information to demonstrate that the product is in compliance with FDA
regulations. Product information should include device name and product code
. FDA, CDRH, issued a letter which clarifies what entry information should
be provided at the time of entry. The correct information will help expedite
the entry review process and increase the likelihood that your shipment may
be processed based on import system screening and not held for further FDA
entry review. Please note that the product code provided to CBP must include
a two digit prefix identifying the medical specialty in addition to the
three letter code. The medical specialty codes are as follows:
(OMITTED, please refer to the original link)
Importers of radiation emitting electronic products subject to a federal
performance standard are required to submit a written declaration on "
Declaration of Products Subject to Radiation Control Standards," form FDA-
2877, along with other import entry information, including accesssion number
, if appropriate, through CBP to the appropriate FDA district office.
Electronic products that fail to comply with the applicable performance
standard or do not have a certification label or tag (21 CFR 1010.2) affixed
to each product shall be refused entry.
Most importers ask that domestic customhouse brokers (or filers) complete
these forms electronically and make the submissions on their behalf. Filers
have access to the Operational and Administrative Systems for Import Support
(OASIS), the FDA computerized import system. The OASIS program is an
electronic interface between FDA and the CBPs Automated Commercial System (
ACS). OASIS is an on-line interactive and automated system, which replaced
the process of reviewing the paperwork for import entries manually.
When an entry is filed with CBP, a copy of the entry is also provided to the
local FDA district office. The FDA district office then determines if the
product complies with FDA requirements. The FD&C Act authorizes FDA to
detain a regulated product that appears to be out of compliance with the Act
. If a product appears to be out of compliance, the FDA district office will
issue a "Notice of FDA Action" specifying the nature of the violation to
the owner or consignee. The owner or consignee is entitled to an informal
hearing in order to provide testimony regarding the admissibility of the
product. If the owner fails to submit evidence that the product is in
compliance or fails to submit a plan to bring the product into compliance,
FDA will issue another "Notice of FDA Action" refusing admission to the
product. The product then has to be exported or destroyed within 90 days.
Failure to do so within 90-days may result in issuance of a Customs
Redelivery Notice and an assessment for liquidated damages for up to 3 times
the value of the lot.
Upon entry, FDA may examine certain devices to assure their safety and
effectiveness. When this occurs, FDA will issue a notice to the importer of
a record on a form titled "Notice of FDA Action." Sampling may involve
examining the product at the port of entry or physical collection of a
statistical portion of the lot for analysis by an FDA laboratory. If the
sample is violative, or if the sample is determined to be out of compliance
with required specifications, the device will be detained and the importer
of record will be issued a "Notice of FDA Action" indicating that the
article is being detained due to the appearance of a violation under the FD&
C Act. The "Notice of FDA Action" will state the specific violations to the
FD&C Act.
Under certain conditions, the importer of record of a device that has been
detained, is given an opportunity to submit application for authorization to
bring the device into compliance with the FD&C Act. If FDA permits
reconditioning, another sample may be collected and analyzed after
reconditioning. If the device is then determined to be in compliance, it
will be released. Only the FDA District Office at the port of entry has the
authority to authorize reconditioning and/or to release the shipment. You
must provide the appropriate documentation or bring the products into
compliance unde ther authorization from the District Office. When contacting
the District Office, you should ask for the Compliance Office and provide
the entry number and/or sample number as a reference.
Additional information on importation of medical devices can be found in the
following documents:
Regulatory Procedures Manual, Chapter 9, Import Procedures
FDA Investigations Operations Manual, Chapter 6, Imports
Import Alerts
Import Program System Information
Import for Export
A firm may import device parts, components, subassemblies, etc. for further
processing or incorporation into unapproved devices which are to be
subsequently exported. A firm may not import a finished unapproved device
without prior marketing clearance, even if the device is to be imported
solely for subsequent export. The terms "further processing" and "
incorporation" as detailed in the Regulatory Procedures Manual is rather
broad in its interpretation. For example, a device imported for further
packaging or labeling would fall into this category; a device which is
simply stored without any further action prior to export would not fall into
this category.
The provisions for import for export under section 801 of the FD&C Act have
been amended by the section 322 of Bioterrorism Act of 2002. Importers
wishing to import devices (including components or an accessory of a device
or other article of a device requiring further processing, which is ready or
suitable for use for health-related purposes) that are intended for further
processing or incorporation into another product and subsequest export must
provide FDA with certain information at the time of initial importation.
The information includes a statement that confirms the intent to further
process such article or incorporate such article into a product to be
exported and identifies entities in the chain of possession of the imported
article. At the time of initial importation and before delivery to the
importer, initial owner, or consignee, a bond must be executed providing for
liquidated damages in the event of default, in accordance with Bureau of
Customs and Border Protection (formerly called U.S. Customs) requirements.
The initial owner or consignee of the article must maintain records of the
use and/or destruction of such imports and must submit the records or a
report to FDA upon request. Additional guidance on import for export can be
found in Chapter 9 of the Regulatory Procedures Manual, Import for Export.
References
Regulatory Procedures Manual, Chapter 9, Import Procedures
FDA Investigations Operations Manual, Chapter 6, Imports
Import Alerts
Import Program System Information
Regulatory Procedures Manual.
Food Drug & Cosmetic Act
Compliance Policy Guides
Export of FDA Regulated Products from U. S. Foreign Trade Zones, Compliance
Policy Guide, Section 110.200 (CPG 7150.11)
Food and Drug Guaranty - Imports, Compliance Policy Guide, Section 110.500 (
CPG 7153.10)
FDA Authority Over Products of Foreign Origin Located in Foreign Trade Zones
, Bonded Warehouses or on Bonded Carriers, Compliance Policy Guide, Section
110.600 (CPG 7150.14)
Seizures by the U. S. Customs Service of Prohibited Articles of Foreign
Origin Not Intended for Entry into the United States, Compliance Policy
Guide, Section 110.700 (CPG 7153.08)
Imports, Post Detention Sampling, Compliance Policy Guide, Section 110.800 (
CPG 7150.04)
Imported Products - Lack of English Labeling, Compliance Policy Guide,
Section 110.900 (CPG 7150.15)
Regulations 21 CFR 1, Subpart E--Imports and Exports
§1.83 - Definitions.
§1.90 - Notice of sampling.
§1.91 - Payment for samples.
§1.94 - Hearing on refusal of admission.
§1.95 - Application for authorization to relabel and recondition.
§1.96 - Granting of authorization to relabel and recondition.
§1.97 - Bonds.
§1.99 - Costs chargeable in connection with relabeling and reconditioning
inadmissible imports.
z***a
发帖数: 8436
2
有意思!
有空了我要慢慢看
美女是对medical device感兴趣,还是来给太尉捧场的呀?呵呵

Premarket
.S

【在 s*********e 的大作中提到】
: Source:
: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/I
: Importing into the U.S.
: Please note: as of October 1, 2002, FDA charges fees for review of Premarket
: Notification 510(k)s and Premarket Approvals
: Overview
: Foreign firms that manufacture medical devices and/or products that emit
: radiation that are imported into the United States must comply with
: applicable U.S. regulations before, during, and after importing into the U.S
: . or its territories. In order to import medical devices and/or products

h********e
发帖数: 2823
3
无香也来了,呵呵!
我假公济私,kaka
捐了那么多包子,得在这里多吃点儿赚回来 :P

【在 z***a 的大作中提到】
: 有意思!
: 有空了我要慢慢看
: 美女是对medical device感兴趣,还是来给太尉捧场的呀?呵呵
:
: Premarket
: .S

s**********8
发帖数: 25265
4
super!

Premarket
.S

【在 s*********e 的大作中提到】
: Source:
: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/I
: Importing into the U.S.
: Please note: as of October 1, 2002, FDA charges fees for review of Premarket
: Notification 510(k)s and Premarket Approvals
: Overview
: Foreign firms that manufacture medical devices and/or products that emit
: radiation that are imported into the United States must comply with
: applicable U.S. regulations before, during, and after importing into the U.S
: . or its territories. In order to import medical devices and/or products

h********e
发帖数: 2823
5
谢谢版主包子!
最近在贵版吃到很撑!

【在 s**********8 的大作中提到】
: super!
:
: Premarket
: .S

1 (共1页)
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巴西就是牛Humanitarian Use Devices (HUD)
相关话题的讨论汇总
话题: fda话题: import话题: product话题: compliance话题: device